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57–983 PDF 2010

S. HRG. 111–651 

DIETARY SUPPLEMENTS: WHAT SENIORS NEED 

TO KNOW 

HEARING 

BEFORE THE

SPECIAL COMMITTEE ON AGING 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

WASHINGTON, DC 

MAY 26, 2010 

Serial No. 111–18 

Printed for the use of the Special Committee on Aging 

( 

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

BILL NELSON, Florida 

ROBERT P. CASEY, Jr., Pennsylvania 

CLAIRE McCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

MARK UDALL, Colorado 

KIRSTEN GILLIBRAND, New York 

MICHAEL BENNET, Colorado 

ARLEN SPECTER, Pennsylvania 

AL FRANKEN, Minnesota 

BOB CORKER, Tennessee 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

GEORGE LeMIEUX, FLORIDA 

ORRIN HATCH, Utah 

SAM BROWNBACK, Kansas 

LINDSEY GRAHAM, South Carolina 

SAXBY CHAMBLISS, Georgia 

DEBRA WHITMAN, Majority Staff Director 

MICHAEL BASSETT, Ranking Member Staff Director 

(II) 

C O N T E N T S 

Page 

Opening Statement of Senator Herb Kohl ............................................................. 1 

Opening Statement of Senator Bob Corker ........................................................... 3 

Opening Statement of Senator Al Franken ........................................................... 3 

Opening Statement of Senator Orrin Hatch ......................................................... 3 

PANEL I 

Statement of Greg Kutz, Forensic Audits and Special Investigations, Government Accountability Office, Washington, DC .................................................... 6 

Statement of Tod Cooperman, President, Consumerlab.com, White Plains, 

NY ......................................................................................................................... 36 

Statement of Charles Bell, Program Director, Consumers Union, Yonkers, 

NY ......................................................................................................................... 43 

Statement of Steven Mister, President and CEO, Council for Responsible 

Nutrition, Washington, DC ................................................................................. 61 

PANEL II 

Joshua Sharfstein, Deputy Commissioner, Food and Drug Administration, 

Silver Spring, MD ................................................................................................ 98 

APPENDIX 

Prepared Statement of Senator Al Franken .......................................................... 127 

Mr. Mister’s Response to Senator Al Franken’s Question .................................... 127 

Testimony submitted by The Coalition for Dietary Supplements, Washington, 

DC .......................................................................................................................... 128 

(III) 

(1) 

HEARING ON DIETARY SUPPLEMENTS: WHAT 

SENIORS NEED TO KNOW 

WEDNESDAY, MAY 26, 2010 

U.S. SENATE, SPECIAL COMMITTEE ON AGING, Washington, DC. 

The committee met, pursuant to notice, at 2:05 p.m. in room SD– 

562, Dirksen Senate Office Building, Hon. Herb Kohl (chairman of 

the committee) presiding. 

Present: Senators Kohl [presiding], Franken, Corker, and Hatch. 

OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN 

The CHAIRMAN. Good afternoon. We’d like to thank our witnesses 

for participating in today’s hearings on dietary supplements. 

The use of dietary supplements, which can take the form of vitamins, minerals, fiber, or other nutritional products, has grown substantially over the past few decades. Recent surveys indicate that 

at least 40 percent of American adults consume these products, 

many of which can serve as a valuable addition to daily diets. 

Today, we’ll address concerns that have arisen over whether the 

marketing and manufacturing of these products meet the standards that American consumers deserve. 

Dietary supplements have become a multibillion-dollar industry. 

In 2006, Americans reportedly spent $23 billion on herbal and specialty supplements, which is almost half the amount that they 

spent on prescription drugs. However, several consumer safety 

issues arise with these products. Because dietary supplements are 

available over the counter, consumers sometimes take them in addition to, or even as a replacement for, other prescription medication or drugs, without consulting their doctors or receiving notification of potentially harmful interactions. In fact, the accurate information is not always easily accessible to the average consumer. 

The number of scientific studies conducted on the safety or efficacy of herbal supplements is limited, and unlike pharmaceutical 

drugs, these supplements are not subject to FDA approval before 

being marketed and sold. In addition, claims about these products 

and advertisements are subject to only limited regulation. 

In 2007, the FDA released Good Manufacturing Practices, or 

GMPs, that began to address some of these concerns. Though it 

took 13 years to complete them, these guidelines are intended to 

improve the safety and production of dietary supplements. 

The industry itself has stepped up oversight efforts and has 

taken on an active role in monitoring its own practices and helping 

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fectively deal with misleading ads and unfair marketing. Despite 

these positive developments, we’ll hear today that legitimate concerns remain about the industry. 

A Government Accountability Office investigation uncovered both 

improper advertising and marketing of dietary supplements, as 

well as the existence of contaminants, such as mercury, lead, and 

pesticides, in certain products. 

While the levels of contaminants have not set off alarms with 

Federal regulatory officials or scientists, some exceed allowable 

limits. As part of their investigation, GAO referred marketing and 

contaminant samples to FDA and FTC for further review and possible action. Given these findings, it’s obvious that more must be 

done. 

We look forward to working with colleagues in the Senate, including Senators Harkin and Hatch, and Senators McCain and 

Dorgan, who have long taken an interest in dietary supplement 

issues, in order to ensure that meaningful provisions addressing 

these issues are included in the Food Safety Act, soon to come 

about. 

We need to be sure companies are properly registered, including 

their product lists, so that FDA has the ability to identify and act 

on safety concerns. Since two-thirds of consumers believe the government requires supplement labels to contain warnings about potential side effects or dangers, we must ensure consumers receive 

comprehensive information about the safety of these products, by 

requiring warning labels on products that contain ingredients 

known to have adverse effects or harmful interactions with prescription drugs. We should also encourage vigorous oversight to reduce and eliminate dangerous contaminants even in small 

amounts. We need to ensure that FDA has the authority to recall 

products that are found to harm those who take them. 

Finally, as FDA authority expands, we need to continue to provide them with the resources to do these things. Last year, we were 

successful in securing a $152-million increase for FDA’s food safety 

oversight, and we’ll continue to advocate for additional funding in 

the future. 

Now, let’s be clear, no one is suggesting that consumers should 

not be able to take vitamins or other dietary supplements. Our concern is that be able—that they be able to do so safely. American 

consumers should have access to comprehensive, accurate information about these products so that they are empowered to make the 

best decisions about their own health. 

We thank you once again for being here, one and all. 

We turn, now, to the ranking member, Senator Corker, for his 

comments. 

3 

OPENING STATEMENT OF SENATOR BOB CORKER, RANKING 

MEMBER 

Senator CORKER. Mr. Chairman, thank you. I thank you for having this hearing, and certainly welcome the witnesses. 

I wake up every morning, drink a cup of coffee, and take some 

dietary supplements. Certainly I care about the safety of those. I 

know today we going to hear about some of the practices of vendors 

and others relating to dietary supplements. 

I do want to point out that, back in 1994, we passed a law, 

DSHEA, that in implementation, would have overseen the safety of 

many of these dietary supplements. Sixteen years later, we still 

haven’t fully implemented a portion of that law, which is Good 

Manufacturing Practices. 

I think one of the things that we should do here in Congress, before we look at passing new laws, is try to make sure the laws that 

are on the books are actually implemented appropriately. 

So, today I look forward to hearing from our witnesses. As I’ve 

said, I thank you for coming, and certainly look forward to being 

educated, in the process. 

Thank you very much. 

The CHAIRMAN. Thanks, Senator Corker. 

Senator Franken. 

OPENING STATEMENT OF SENATOR AL FRANKEN 

Senator FRANKEN. I really have no opening comments. 

I’m eager to hear the witnesses and thank them for coming. 

Thank you, Mr. Chairman, for having this hearing. 

The CHAIRMAN. Thank you, Senator Franken. 

Senator Hatch. 

OPENING STATEMENT OF SENATOR ORRIN HATCH 

Senator HATCH. Well, thank you, Mr. Chairman. 

As the author, along with Senator Harkin, of the DSHEA—of the 

Dietary Supplemental Health and Education Act—if you don’t 

mind, I would like to make a formal statement. 

The CHAIRMAN. Sure. 

Senator HATCH. I appreciate you, Mr. Chairman, for allowing me 

to. 

This issue before the committee today is extremely important to 

my home State of Utah, and my fellow Utahans, and, I think, every 

citizen in America. I want all Americans, including senior citizens, 

to have the best and most accurate information about the dietary 

supplements that they use. 

False health claims about these products, on the Internet and 

newspaper ads or on product labels, are illegal today. So is selling 

contaminated dietary supplements. Companies engaging in these 

types of activities are breaking the law, and therefore, should be 

taken off the market immediately. That power is granted through 

current law. So, amending that law is not necessary. What is necessary is providing the Food and Drug Administration the funding 

it needs to properly enforce and implement current law. 

As an original author of the 1994 Dietary Supplement Health 

Education—Health and Education Act, and the Nonprescription 

4 

Drug Consumer Protection Act of 2006, it is important for committee members to understand the history behind these laws. 

Senator Tom Harkin and I were the lead sponsors of both bills, 

which enjoyed strong bipartisan support. In fact, DSHEA passed 

the Senate twice, by unanimous consent; in the House of Representatives, once, by unanimous consent. DSHEA established a 

statutory framework for the FDA so that dietary supplements are 

regulated as foods. The law grandfathered U.S. dietary supplements already on the market at the time of its enactment, because 

these products had a history of safe use. DSHEA also includes a 

strong safety standard so that potentially harmful products could 

be removed from the market. 

Through DSHEA, the FDA has an imminent hazard authority it 

may use to immediately remove any unsafe product from the market. The law also requires manufacturers to submit marketing safety information to the FDA about any new agreements not previously marketed. This information must be submitted to the FDA 

75 days prior to putting a product on the market. 

Another key provision authorized issuance of Good Manufacturing Practice, or GMP, standards so that FDA inspectors could 

ensure products are being manufactured in compliance with the 

law. One of my biggest frustrations was that, once the DSHEA was 

signed into law, it took the FDA many years to implement any 

GMP standards. Today, these GMP standards apply to large- and 

medium-sized manufacturers, and, in a few weeks, will apply to 

small manufacturers. 

Finally, DSHEA required that all ingredients on dietary supplements be listed on the label, and that any claims made must be 

truthful and not misleading. Misleading claims or labels are a violation of the law, and the FDA should take products with misleading claims and labels off the market, period. 

Some have argued that dietary supplements should be subject to 

premarket approval. But, let me explain why this is not done. Most 

dietary supplements have been used safely for years and raised no 

concerns warranting the time and resources necessary for premarket approval, or even review. The entire time Senator Harkin 

and I were writing this legislation, not one Member of Congress 

raised any concerns about the Grandfather Clause. 

In addition, the FDA has not been able to find the necessary resources to even enforce the current law. As chairman of the Appropriations Subcommittee which funds the FDA—you are aware of 

this issue. Therefore, it is clear to me that FDA has much higher 

priorities than dietary supplements. Moreover, the FDA has not 

asked for additional funding for supplement enforcement, which I 

believe is an indicator these products are not the safety concerns 

some would argue from the cases highlighted at this hearing. 

The Dietary Supplement and Nonprescription Drug Consumer 

Protection Act of 2006 mandated a system to provide the government with information about serious adverse events associated 

with the use of the two FDA-regulated products: dietary supplements and over-the-counter drugs. This law requires manufacturers, packers, or distributors of these products to provide to the 

FDA, within 15 business days, any reports of serious AERs. It also 

is important to note that previous FDA commissioners—Dr. Jane 

5 

Henney, Dr. Mark McClellan, Dr. Lester Crawford, and Dr. Andy 

von Eshenbach—have all stated, in Senate hearings and in meetings—in my meetings with them—that through DSHEA they had 

the power necessary to regulate dietary supplements. Moreover, 

current FDA commissioner, Dr. Margaret Hamburger—Hamburg, 

excuse me—has assured me that she will work with me to ensure 

that these laws are enforced. 

To ensure that these laws are properly enforced, Senator Harkin 

and I introduced a Dietary Supplement Full Implementation and 

Enforcement Act of 2010. This legislation requires the Secretary of 

Health and Human Services to submit annual reports to Congress 

regarding HHS activities on dietary supplements. It directs the 

FDA to issue its ‘‘new dietary ingredient,’’ or NDI, guidance, as recommended by the General Accountability Office, within 180 days, 

and requires the FDA to notify the Drug Enforcement Agency if it 

finds that a new dietary ingredient being evaluated contains an anabolic steroid. Now, I’m also the author of the Anabolic Steroid law, 

along with now-Vice President Biden. We’ve worked hard to make 

sure that the consumers are protected. 

This bill, S. 3414, is supported by the Major League Baseball 

Players Association, the NFL Players Association, the Natural 

Products Association, the United Natural Products Alliance Council 

for Responsible Nutrition, American Herbal Products Association, 

and the Consumer Healthcare Products Association. So, I urge the 

members of the committee to seriously consider supporting our bill. 

Now, Mr. Chairman, before I close, I want to emphasize that a 

vast majority of the dietary supplement industry are providing consumers not only with safe products, but also accurate information 

about their use. They, too, want bad-actor companies—and certainly I do, as well—off the market. 

So, as chairman of the Agricultural Appropriations Subcommittee, please work with me, Mr. Chairman, to ensure that the 

FDA has the money to enforce existing laws. That should be this 

committee’s first goal. We should not be talking about changing 

current law; and, instead, focus on enforcing current law. Hopefully, today’s hearing will begin such discussions. 

Thank you, Mr. Chairman, sorry it took so long. 

The CHAIRMAN. Thank you very much, Senator Hatch, for your 

statement. 

We’ll now introduce the first panel. 

The first witness today will be Greg Kutz. Mr. Kutz is the Managing Director of the Government Accountability’s Office of Forensic Audits and Special Investigations Unit. The unit is charged 

with providing Congress with the results of these forensic audits 

and investigations. 

Our second witness today will be Tod Cooperman. Dr. 

Cooperman is the President and Founder of ConsumerLab.com and 

PharmacyChecker.com, which publish consumer reports and independent evaluations of popular products and online pharmacies. 

He’s a graduate of Boston University’s School of Medicine. 

Third today will be Charles Bell. Mr. Bell is a Programs Director 

for Consumers Union, the nonprofit publisher of Consumer Reports 

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tive information on health insurance and other consumer 

healthcare issues. 

Next, we’ll be hearing from Steve Mister. Mr. Mister is the President and CEO of the Council for Responsible Nutrition, a trade association that represents product manufacturers and raw ingredient suppliers of dietary supplements. Mr. Mister is speaking here 

today on behalf of the five major trade organizations. He’s a former 

Vice President and Associate General Counsel for the Consumer 

Healthcare Products Association. 

We welcome you all here today, and we’re looking forward to 

your statements, hopefully at about 5 minutes. 

Mr. Kutz. 

STATEMENT OF GREG KUTZ, FORENSIC AUDITS AND SPECIAL 

INVESTIGATIONS, GOVERNMENT ACCOUNTABILITY OFFICE, 

WASHINGTON, DC 

Mr. KUTZ. Mr. Chairman and members of the committee, thank 

you for the opportunity to discuss dietary supplements. 

Today’s testimony highlights the results of our investigation into 

allegations of deceptive marketing practices. My testimony has two 

parts. First, I will discuss the marketing of supplements; and second, I will discuss our testing of supplements for harmful substances. 

First, posing as fictitious elderly consumers, we tested the marketing practices of numerous storefront and mail-order retailers. 

This included telephone calls across the country and in-store visits 

here in the Washington, D.C., area and in Florida. We also evaluated claims made on Web sites and in other written materials. 

What we found was deceptive marketing practices related to supplements frequently used by the elderly. 

Perhaps more alarming was the dangerous medical advice provided to our fictitious consumers. Key claims made include: first, 

supplements can prevent and cure serious disease; second, supplements can replace prescription medications; and, third, supplements can safely be combined with aspirin or other medications. 

I have in my hand a bottle of garlic capsules that cost us about 

$11 for a 30-day supply. Mr. Chairman, you’ll be amazed to know 

that this product, according to its marketing materials, ‘‘prevents 

and cures cancer.’’ As an added bonus, it ‘‘prevents the common 

cold, obesity, and diabetes.’’ If these claims were true, imagine how 

this product could reduce healthcare costs in this country. 

Next, I have in my hand a bottle of ginseng capsules that cost 

us about $10 for a 50-day supply. In another amazing claim, this 

product ‘‘reduces brain damage from a stroke.’’ As an added bonus, 

it’s supposed to ‘‘treat Lou Gehrig’s disease, and improve digestion, 

endurance, and sexual performance.’’ There are numerous supplements claiming to treat and cure things like cancer and Alzheimer’s disease. You can see these products for sale on eBay, 

Amazon.com, and craigslist. 

So, what’s the problem with this? These products should not be 

marketed as a treatment or cure for specific disease without FDA 

approval as a drug. None of these products has that FDA approval. 

In addition to these deceptive claims, we found other dangerous 

information provided to our fictitious consumers. For example, we 

7 

were told that we could stop taking our prescription medication for 

high blood pressure, and instead, take garlic. In another case, we 

were told that we could take ginkgo with our daily prescription of 

aspirin. According to FDA, combining ginkgo with aspirin can increase the risk of bleeding. As the Chairman mentioned, we have 

referred several of these cases to FDA and FTC for further investigation. In a moment, I will play for you excerpts from some of our 

undercover visits and phone calls to sellers of supplements. 

Moving on to my second point, we found trace amounts of harmful substances in 37 of the 40 herbal supplements that we tested. 

All 37 had trace amounts of lead, while others had trace amounts 

of items such as mercury, arsenic, and pesticides. However, FDA 

and EPA do not consider these trace amounts to be an immediate 

health risk. 

In conclusion, the deceptive marketing and dangerous advice 

identified pose a risk to the health of the elderly and perhaps other 

consumers. Aggressive marketers are providing consumers with unsubstantiated claims that their products can treat incurable disease. My advice to consumers across the country is to consult with 

your doctor before taking any dietary supplements. 

I will now play the audio excerpts I mentioned, Mr. Chairman, 

of our marketing tests. You will see the transcription of the conversations on the monitors as you listen. 

[Video presentation.] 

Mr. KUTZ. Mr. Chairman, I applaud you and the other members 

of the committee for your efforts today to protect elderly and other 

consumers from the deceptive marketing of dietary supplements. 

That ends my statement, and I look forward to your questions. 

[The prepared statement of Mr. Kutz follows:] 

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The CHAIRMAN. Thank you very much, Mr. Kutz. 

Dr. Cooperman. 

STATEMENT OF TOD COOPERMAN, PRESIDENT, 

CONSUMERLAB.COM, WHITE PLAINS, NY 

Dr. COOPERMAN. OK. Senators Kohl, Senator Corker—— 

Can you hear me? OK. 

Senators Kohl and Corker, members of the committee, I’m Dr. 

Tod Cooperman, President of ConsumerLab.com, a company that I 

founded 11 years ago to help consumers better identify high-quality 

health and nutrition products based on independent testing. 

I’m accompanied by Dr. William Obermeyer, our Vice President 

for research, who spent 9 years at the FDA, testing foods and dietary supplements within the Center for Food Safety and Applied 

Nutrition. 

We appreciate this opportunity to present findings that are particularly relevant to the aging population. 

ConsumerLab’s testing is funded by over 40,000 individual and 

institutional subscriptions to our Web site. We also provide a voluntary certification program, and test products for clinical researchers, particularly those funded by the NIH. Our recent survey 

of people who receive our free e-newsletter revealed that, among 

those aged 65 and older, 32 percent use 10 or more supplements 

daily. 

A senior citizen in a vitamin store is a bit like a kid in a candy 

store. However, while the FDA recommends a strict limit on lead 

contamination in candy, it has not set a limit in supplements. Our 

tests show that this policy has created a buyer-beware situation. 

Based on tests of over 2,000 dietary supplements, representing over 

300 different brands, we find that one out of four has a quality 

problem. Problems have been found in products from every-size 

manufacturer and are most common in herbal supplements, multivitamins, and products with ingredients that are newer to the market. 

The most common problem is a lack of ingredient or substandard 

ingredient. Our most recent tests of herbal supplements show that 

46 percent contained less than their expected amounts of key compounds. For example, an extra-strength ginseng product provided 

less than 10 percent of the claimed amount of expected ginsenoside 

compounds. We reported a similar problem with the same product 

3 years earlier. 

A major cause of these problems is the reliance by some manufacturers on cheap, nonspecific tests which overstate the amount of 

actual ingredient in raw materials and supplements. More specific 

tests show the actual amounts to be lower. 

The next most common problem is contamination with lead and 

other heavy metals. The FDA professes a policy of reducing lead 

levels to the lowest amount that can be practicably obtained in 

manufacturing, yet the FDA has neither set, nor suggested, limits 

on heavy metals in supplements. 

The only limit for lead in supplements in the United States is in 

the State of California. That limit, which is half of a microgram per 

daily serving, typically works out to be just slightly higher than the 

FDA candy limit. But, it is still very conservative and meaningful. 

37 

Products sold in California exceeding this limit must carry a warning label. ConsumerLab has found that 11 percent of herbal supplements exceed the California limit for lead. 

Cadmium, a toxin and carcinogen, also occurs in certain herbal 

supplements, but the FDA has not set a limit on cadmium in supplements. ConsumerLab has found that 40 percent of St. John’s 

wort supplements and 14 percent of valerian supplements exceed 

World Health Organization guidelines for cadmium contamination. 

While individual products with elevated levels of lead and cadmium are generally not toxic in themselves, they unnecessarily expose Americans to toxins, and the effects are cumulative. As noted 

earlier, many seniors take 10 or more supplements daily, and additional exposure comes from foods, beverages, and the environment. 

It would be dangerous to suggest that a single supplement needs 

to contain a toxic amount of heavy metal to be a threat to health. 

However, a 2007 report by the FDA on lead contamination in 

multivitamins made this faulty assumption, and has been criticized 

for doing so. 

Unfortunately, the USP may soon adopt an industry proposal 

permitting 10 micrograms of lead per daily serving of a supplement, 20 times higher than the California limit. We think such a 

lax standard would be a terrible mistake, permitting an individual 

supplement to exceed the total amount of lead that a child can tolerate, and just a few supplements to surpass the daily threshold 

for adults. 

Will Good Manufacturing Practices help? These practices, as 

mentioned, are now required of most supplement manufacturers to 

help ensure batch-to-batch uniformity. However, bad products can 

be made under Good Manufacturing Practices, because the GMPs 

do not include standards for purity and ingredient identity. These 

standards, and the selection of tests used to measure against them, 

are left to each manufacturer to determine for itself. 

In conclusion, nearly 11 years of product reviews by 

ConsumerLab.com have shown consistent problems with a significant percentage of dietary supplements, particularly herbal supplements. However, in nearly every supplement category that we do 

test, we do find products that meet high quality standards, showing 

that this is achievable. If we want our supplements to be the best 

and safest in the world, we will need to have better guidance from 

the government, establishing rigorous standards and test methods, 

greater enforcement of current regulations, and more self-regulation from the industry. 

In my written testimony, you’ll find additional statistics, information, and references. Thank you for your time. 

[The prepared statement of Dr. Cooperman follows:] 

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The CHAIRMAN. Thank you very much, Dr. Cooperman. 

Mr. Bell. 

STATEMENT OF CHARLES BELL, PROGRAM DIRECTOR, 

CONSUMERS UNION, YONKERS, NY 

Mr. BELL. Chairman Kohl, Ranking Member Corker, members of 

the committee, I’m Charles Bell. I work for Consumers Union, the 

nonprofit publisher of Consumer Reports, based in Yonkers, NY. 

I just wanted to point out, at the outset, that even though Dr. 

Cooperman and I both come from New York, we have no official relationship with ConsumerLab.com. We’re separate organizations. 

We certainly appreciate the research work that they are doing. 

If—I would—I submitted a rather long written statement. I 

would just summarize some of the highlights. 

In terms of senior use of dietary supplements, findings from several sources indicate that dietary supplement use generally increases with age. According to a survey published in the Journal 

of American Medicine, 49 percent of Americans aged 57 to 85 use 

a dietary supplement and 52 percent of seniors reported using supplements concurrently with prescription drugs. 

Many dietary supplements, including most vitamins and minerals, taken within recommended limits are generally safe and can 

have important benefits for consumers. However, Consumers Union 

is concerned that there’s a significant and growing number of highly questionable products that are entering the market that would 

probably fail rigorous safety testing. 

We would note that, since the passage of DSHEA in 1994, the 

marketplace has grown. This is quite a large and dynamic marketplace today, with industry sources estimating there could be between 30- to 75,000 dietary supplement products on the market, 

with another 1,000 new products or so entering every year. So, 

that’s a lot of products for the FDA and other health authorities 

to keep an eye on. We think, at the same time, that consumers and 

seniors really do need to be aware that there are significant unresolved safety problems with dietary supplements. 

We publish, in Consumer Reports over the last 20 years or so, 

several articles with lists of unsafe supplements that we think consumers should avoid. For example, in 1995 we published an article 

calling out five herbal supplements, including ephedra. But, the 

other four that were on that list—chaparral, comfrey, lobelia, and 

yohimbe—continue to be sold in the market today. We updated our 

list in 2004 and 2008. 

Generally when Consumer Reports warns about product hazards, 

we’re used to seeing some type of swift response from the marketplace, either of the product being corrected or fixed by manufacturers, or withdrawn by the governments. We are concerned that we 

see a lot of products that we think consumers should not be running into staying on store shelves that could be a dangerous surprise for a senior or a consumer. 

But, we also have advised consumers not to use weight-loss supplements, generally speaking. We are concerned about multi-ingredient herbal supplements, often with concentrated herbal extracts 

spiked with stimulants, like bitter orange or high levels of caffeine. 

We’ve also been concerned about supplements marketed for sexual 

44 

enhancement purposes that also have high levels of stimulants and 

multiple ingredients, and sometimes also turn out to be contaminated with prescription drugs. 

We are concerned that FDA does not have a program of manufacturer registration. When the HHS inspector general visited FDA in 

2001, they found that the agency was unable to provide information for many, many products that it should supposedly be overseeing. 

We cite, in our testimony, information about the increasing 

amount of imported ingredients that are used in supplement manufacturing. China now provides about one-third of global vitamin 

manufacturing, and many herbal and other botanical and dietary 

supplement products are sourced there, as well. We are concerned 

about whether the FDA really has sufficient resources to police the 

imports of products from China, or any other country, because 

there are many other countries that are potentially involved. 

We have also expressed concern about new supplements that 

contain nanoparticles. There is a report that was done by the 

Project Emerging—on Emerging Nanotechnologies, here in DC., 

that there’s more than 44 dietary supplements with nanoparticles 

that have already entered the marketplace. We don’t—we’re not 

sure the FDA has looked at the safety profile for any of these, and 

we do not think that they should be permitted to be sold until they 

are subject to premarket safety testing. 

We believe that seniors really do need to be aware of interactions 

between—potential interactions between prescription drugs and dietary supplements. As noted, 52 percent of seniors are also taking 

prescription drugs. There are many, many different warnings for 

different types of supplements. For example, ginkgo biloba can 

interfere with blood clotting, and physicians generally advise consumers to cease from using herbal medicine 2 weeks prior to having surgery. In other cases, the supplement can lower the effectiveness of the prescription drugs that consumers are taking, or actually intensify it. 

So, we support the Dietary Supplement Safety Act of 2010 that 

would strengthen public oversight of dietary supplements. It would 

include provisions for manufacturer registration, mandatory recall 

authority, and reporting of nonserious adverse events. 

We thank you very much for your interest in these issues, and 

look forward to working with the committee, and with the industry, 

to address the problems that are being discussed here today. 

[The prepared statement of Mr. Bell follows:] 

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The CHAIRMAN. Thank you, Mr. Bell. 

Now we’ll hear from Mr. Mister. 

STATEMENT OF STEVEN MISTER, PRESIDENT AND CEO, 

COUNCIL FOR RESPONSIBLE NUTRITION, WASHINGTON, DC 

Mr. MISTER. Good afternoon. My name is Steve Mister. I’m the 

President of the Council for Responsible Nutrition. 

More than 150 million Americans take dietary supplements each 

year, including many who are extremely passionate about their 

rights to purchase supplements and to have access to information 

about their health choices. 

The dietary supplement industry is committed to manufacturing 

and marketing high quality, safe, and beneficial products that have 

a valuable role in a wellness regimen. This industry is likewise 

committed to ensuring that consumers receive truthful, accurate, 

and nonmisleading information on dietary supplements. 

We also share the committee’s concerns about bad actors in the 

industry, whether they are unaware of the extensive regulatory 

framework governing dietary supplements or they are willfully 

breaking the law. We condemn adulterated or misbranded products, and we denounce false, misleading, or deceptive marketing 

practices, activities that are engaged in by a very small minority, 

who damage the reputation of the responsible industry. 

The supplement industry, as a whole, has a demonstrated track 

record of providing high quality products to its consumers, as well 

as a reputation on Capitol Hill for active lobbying for stronger enforcement of the law under which our industry operates. Our industry has gone even further; through its five industry associations, we have developed a variety of voluntary self-regulatory programs that address the issues that have the potential to tarnish 

our industry and hurt our consumers. 

So, let’s put some perspective on the committee’s concerns: 

First, the notion that supplement users will forsake conventional 

medicine or other healthy behaviors is a myth. To the contrary, 

supplement users are more likely than nonusers to engage in other 

healthy habits, such as eating a healthy diet, exercising regularly, 

and visiting their doctors. 

Second, among our passionate supplement users are a high percentage of healthcare professionals—doctors, nurse practitioners, 

pharmacists, and registered dietitians. 

Third, there are literally millions of dietary supplements sold in 

this country each year, and very, very few serious adverse events. 

The strong safety profile for the overwhelming majority of these 

products defies the examples that were raised before the committee. 

Let’s also be clear here that the FDA and the FTC have ample 

authority under existing law to address the concerns that are being 

raised. The Dietary Supplement Health and Education Act authorized FDA to prescribe comprehensive regulations for the manufacturing of supplements, called ‘‘Good Manufacturing Practices.’’ 

When it comes to the safety of ingredients, DSHEA provides the 

agency with the ability to remove products from the market if they 

present an unreasonable or significant risk of injury or illness to 

consumers. It likewise requires companies to notify FDA before 

62 

they bring a new dietary ingredient to the market, and to provide 

evidence that demonstrates a reasonable expectation of the safety 

of the ingredient. The law prohibits labeling claims that purport to 

treat or cure a disease, and it demands that all label claims be 

truthful, not misleading, and substantiated with adequate evidence. 

Separately, the FTC Act gives the Federal Trade Commission 

similar authority over supplement advertising and marketing 

claims, whether made by manufacturers or retailers. 

The problem is that FDA has suffered from a lack of funding, resources, and, until recently, perhaps the political will, to consistently and aggressively enforce and implement this law. The industry calls on Congress today to provide sufficient resources to FDA 

to fully implement the provisions of DSHEA that were enacted 16 

years ago. The Dietary Supplement Full Implementation and Enforcement Act of 2010, introduced recently by Senators Harkin and 

Hatch, will go a long way toward providing adequate funding and 

accountability for FDA. 

The industry recognizes that it, too, must foster a climate of compliance, and all five industry associations have ambitious programs 

to do just that. Individual companies also maintain their own rigorous programs. For instance, all three major vitamin supplement 

retail chains require initial training for all of their entry-level employees, and ongoing continuing education for their retail staffs, to 

remind their employees over and over about the limits on what 

they can and cannot say to consumers. 

However, based on the testimony and the video today, the industry associations recognize that we need to do more. So, today the 

five associations pledge to the committee to increase our efforts to 

educate retailers and their clerks who sell dietary supplements 

about what is permitted under the law. 

We are confident in the role that dietary supplements can play 

in the health and wellness of this Nation, particularly senior citizens. Dietary supplements help to preserve good health and independence for our senior citizens, and they can help to reduce the 

risk of certain chronic diseases. Vitamins fill in nutritional gaps, 

especially when seniors fail to get a nutritious diet, or when aging 

itself reduces their bodies’ natural ability to absorb nutrients from 

conventional food. 

I’m confident this industry and robust government agencies, 

working together, can address the concerns raised today under the 

existing law. We look forward to working with Congress, the FDA, 

and the FTC to provide senior citizens, as well as all consumers, 

with even more confidence in the safety, quality, and benefits of dietary supplements. 

Thank you. 

[The prepared statement of Mr. Mister follows:] 

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The CHAIRMAN. Thank you very much, Mr. Mister. 

As I said, and as you’ve indicated, you’re speaking for virtually 

the entire dietary supplement industry. You were quoted by the 

New York Times as saying that you’ve seen late-night commercials 

for dietary supplement products that, ‘‘made your blood boil,’’. So, 

what more should you and your industry be seeing—be doing about 

this to ensure that your ‘‘blood doesn’t boil’’ and you don’t have to 

take excessive dietary supplements? 

Mr. MISTER. Senator, I don’t know if we have a product for ‘‘blood 

boiling.’’ 

You know, actually, the industry does have a very aggressive approach to these kinds of ads. We were very troubled about this several years ago, and it led to the formation of a program, with the 

Council for the Better Business Bureaus, called the National Advertising Division. Under that program, over the past 3 years, we 

have provided unrestricted grants of almost half a million dollars, 

and over the next 5 years, we will increase that to a total of 1 and 

a half million. It allows the National Advertising Division to look 

at supplement ads, so the ones like I saw on late-night television 

can be referred to the NAD, they can review those ads for the veracity of the claims, decide whether they’re well substantiated, and 

issue a decision. If they recommend a change to the ad and the advertiser chooses to ignore that recommendation, then it can be referred to the Federal Trade Commission. The history is that, when 

those cases go there, the FTC takes high priority on those cases. 

The CHAIRMAN. Well, that’s well and good, but you’ve heard Mr. 

Kutz, today, talk—I mean, he has in his hand dietary supplements 

that make representations that are flatout not true. Now, don’t you 

think your industry should be able to police that? Without—I 

mean, we understand the FDA and its importance. My committee 

oversees the FDA, and we’ve worked hard to get additional monies 

for enforcement; so we’re not indifferent to that need, by any 

means. But, shouldn’t your industry be able to see to it that claims 

that are made, like the ones Mr. Kutz has just—has right in his 

hand, are off the market? 

Mr. MISTER. Well, I think to expect any industry association to 

achieve 100-percent compliance against all its actors is a little unrealistic, Senator. But, first thing I would do would be to encourage 

Mr. Kutz to refer those ads to the NAD—I’d be happy to talk to 

him about how you follow one of those challenges—and to turn over 

the products to the FDA, before Dr. Sharfstein leaves today, so that 

FDA can appropriately prosecute those companies for violating the 

law. 

The CHAIRMAN. You refer to training employees who sell these 

products, very carefully and completely. Yet, as Mr. Kutz indicated 

here on his video, there are employees in your industry who are 

making sales representations that are, again, flatout untrue. When 

I ask you whether or not your industry can do better, of course you 

say, and you should say—and I’m sure you mean—that ‘‘we can do 

a lot better,’’ because I understand that very carefully and clearly. 

But, do you think your industry needs to step up its efforts to see 

to it that products are not misrepresented, either in the manufacturer or in the sale? 

81 

Mr. MISTER. Senator, as I indicated in my testimony, we recognize that we can do more. In fact, one of the other associations, the 

Natural Products Association, already announced, this morning, a 

new retail toolkit that it will get out to its members, who are the 

retailers who sell these products. The other industry associations 

are also evaluating options. 

So, yes, there is more that we can do to make sure that retailers, 

and their clerks, understand what the limits are under the law. 

The CHAIRMAN. Mr. Kutz, in your testimony you outlined several 

examples of what appear to be misleading marketing and advertising claims. Have you reported this information to the FDA or the 

FTC? What do you hope or expect is going to be the outcome? 

Mr. KUTZ. We did—we’ve met with both organizations and sent 

a written referral of the more egregious cases to both organizations. So, that’s what we’ve done. 

The CHAIRMAN. Have they indicated that they’re going to sufficiently take additional look at these reports that you’ve submitted 

to them? 

Mr. KUTZ. I can’t speak with any—certainly they were concerned, 

and I think that they indicated some action, but time will tell 

whether they actually take strict action with this. 

The CHAIRMAN. OK. 

Senator CORKER. 

Senator CORKER. Thank you, Mr. Chairman. Again, thank you 

for having the hearing. 

I appreciate all of you, as witnesses. 

Mr. Mister, the retail salesperson out in the field—I’ve been in 

a lot of these stores, as I’m sure most people in this room have, and 

sometimes there’s a school of thought about a product. I mean, 

some people think garlic does certain things, how would you go 

about, on a realistic basis, with retailers across the country and 

clerks who come in to work in these various units—how would the 

industry go about ensuring that each of these clerks in each of 

these situations with—some of these products are sort of built 

around a belief system that exists about what certain things do. 

There are different beliefs around what they do. How would you, 

in fact, adequately police units like this? Should that even part of 

what your responsibility is, as an entity? 

Mr. MISTER. Well, Senator, there is a lot of emerging evidence, 

very good scientific evidence, about the benefits of supplements, 

that goes beyond just general health and maintenance. So, there 

are research studies now looking at the ability of these products to 

actually prevent diseases and treat diseases. However, unlike the 

belief system, the law is very clear. We’re not allowed to make 

those kinds of claims in our labeling and our advertising. 

So, I think it would be very easy for the industry to develop programs that train their employees, just as some of these major retail 

chains already have, that make it clear that, when you’re talking 

to a consumer, you can talk about basic nutritional information, 

you can talk about those things that are already on the label that 

deal with the structure and function of the body, but you can’t take 

a product—no matter what you personally believe, you can’t take 

a product off the shelf and recommend it to a consumer to treat or 

82 

cure a disease. We can make that message fairly clear to retail 

clerks. 

Senator CORKER. The retail clerk—I expect that I could probably 

go get a job at one of these units pretty easily, even with my lack 

of experience, and would my advocating on behalf of that be based 

on what’s on the label? I mean, is that how these are actually marketed? 

Mr. MISTER. Well, as I indicated, I’ve had the opportunity to talk 

to all three major retail chains, in the last week. Their programs 

differ from one company to another. But, all of them have programs that start with all entry-level employees, and talk to them 

about what they can say about individual products. Then they have 

these continuing programs that go beyond just the basics of what 

you can and cannot say, and will get into particular lines of products. So, these are the things that they could say about weight loss, 

these are the things you can say about general nutrition information, these are things you can say about men’s specialty supplements, or women’s specialty supplements. The longer the employee 

is there, the more training they get. 

Senator CORKER. The laboratory that you use to test these 

units—y’all don’t actually do testing yourself. Y’all get others to do 

the testing and accumulate the information, is that right? 

Mr. KUTZ. We use the lab that FDA had recommended—— 

Senator CORKER. Yeah. 

Mr. KUTZ [continuing]. To us, yes. 

Senator CORKER. So, when you talked about these trace amounts 

that you found, and they were not damaging enough to—the trace 

amounts that you found in most—in all of these products, were not 

enough to actually damage anybody, is that correct? 

Mr. KUTZ. According to FDA and EPA. We do not have the inhouse expertise to make that type of a conclusion, so we consulted—— 

Senator CORKER. Yet—— 

Mr. KUTZ [continuing]. With the government experts on that, 

yes. 

Senator CORKER. So, look—each of us probably, from time to 

time, take prescriptions also, in addition to the dietary supplements that some of us may take daily, and many Americans do. 

What—do you have any idea how that would compare to trace elements that might be found in actual prescription drugs? 

Mr. KUTZ. I wouldn’t have that information, no. 

Senator CORKER. Would that be helpful to know? 

Mr. KUTZ. Perhaps other experts here might know. I just don’t 

know that, sir. 

Senator CORKER. When you test a particular product for someone, are they paying you to do that? How does that come about? 

Are you paid to test products, by the people that are getting ready 

to market them? 

Mr. KUTZ. We did it on behalf of the committee, actually. We 

went—we paid to have these products tested, on behalf of Senator 

Kohl, to test for things like arsenic, pesticides, and things like that. 

So, that’s what we did. 

Senator CORKER. Yeah. 

Mr. KUTZ. I think other people actually—— 

83 

Senator CORKER. But, I assume you have a business model. You 

certainly don’t rely upon this committee, hopefully, to survive. So, 

what do you do, on a daily basis? 

Mr. KUTZ. I’m not sure what you mean. What do we do—— 

Senator CORKER. So, tell me what the company does, outside of 

work here at the committee. 

Mr. KUTZ. I’m with GAO, so—— 

Senator CORKER. Oh, I’m—— 

Mr. KUTZ. Sorry. 

Senator CORKER [continuing]. I apologize. I apologize. [Laughter.] 

Senator CORKER. I apologize. 

Mr. KUTZ. We don’t typically test supplements. 

Senator CORKER. I’m getting my witnesses confused. I apologize. 

Mr. KUTZ. That’s OK. 

Senator CORKER. So, I’m actually thinking about Mr. Cooperman, 

here. I apologize. 

Would you have any ideas as to how these would compare to 

other prescription drugs? 

Dr. COOPERMAN. No, we also don’t regularly test prescription 

drugs—— 

I’m sorry. 

We do not regularly test prescription drugs. We are focused primarily on the dietary supplements. 

Senator CORKER. When someone pays you to test—I assume 

that’s what you do, before they want to market. Is that correct? 

Dr. COOPERMAN. Actually, there are two things that we do, as I 

mention in my testimony. We were set up to help consumers identify better-quality health and nutrition products. So, what we do is 

go out, select, on our own, a group of products, such as the ones 

that you may use, and test them against standards that we can 

find—because again, as I mentioned, the FDA has not set standards, so we use standards from California, World Health Organization, Europe—and test these products against those standards to 

see how they compare, and then publish all results for all those 

products that we’ve selected for testing. 

We also have a voluntary certification program so that any manufacturer can come to us and have a product tested. If it’s certified—it passes all the same tests that we use for the products we 

select—it will be—also be noted, on our Web site, as having met 

that standard. 

Senator CORKER. So, when somebody fails a test, do y’all ever follow back up with that? I mean, what happens when a product 

comes through your lab and actually fails? 

Dr. COOPERMAN. Right. It’s a good question. The products that 

we select for testing, if a product fails, it’s reported publicly as— 

to our subscribers—we have about 40,000 subscribers—what happened with that product. Any manufacturer is welcome to contact 

us, and, within 48 hours, we’ll give them the full results for that 

product, the—where it was purchased, the lot number—to help 

them try to figure out, you know, what the problem is so they can 

correct that problem. 

Senator CORKER. Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you very much. 

Senator FRANKEN. 

84 

Senator FRANKEN. Thank you, gentlemen. 

I just want to get something clear, Mr. Kutz. These claims that— 

these deceptive marketing practices—were these all just oral, or 

were they written on the packaging? 

Mr. KUTZ. Both. 

Senator FRANKEN. Both. 

Mr. KUTZ. Both, yes. 

Senator FRANKEN. OK. So, Mr. Mister talked about voluntary 

self-regulatory regimens. If these are marketed—if these are on the 

packaging, I’m not quite sure how robust this voluntary self-regulatory regimen really could be. I mean, this is—was—on the garlic 

packaging, for example, did it have the claims of—that you’d mentioned? 

Mr. KUTZ. I think it was on the Web site, in that particular case. 

Again, on the packaging piece, I would say that the ones on the 

‘‘prevention, cure, treat disease,’’ those were mostly small companies; that was not your major, national chains. 

Senator FRANKEN. OK, I see. 

Mr. KUTZ. The oral is where the national chains were actually 

giving—four of the seven you saw on the—— 

Senator FRANKEN. I agree with—— 

Mr. KUTZ [continuing]. Were national chains. 

Senator FRANKEN [continuing]. Senator Corker, that—I’ll bet you 

Senator Corker could get a job—— [Laughter.] 

Senator FRANKEN [continuing]. Selling. I’ll bet you he’d be a 

manager within months. [Laughter.] 

Senator FRANKEN. So, I mean, I could see how there might be 

some turnover and that kind of thing. So, I can’t hold the industry 

responsible for every person working there. 

Mr. Bell, how does a Minnesota senior know that the supplement 

that he or she is taking works, and works—and does what it claims 

to do? 

Mr. BELL. Well, it’s—you know, if the person had an advanced 

medical degree, it would be—probably help. It’s quite challenging 

for consumers, on their own, to sort out the efficacy and safety of 

dietary supplements. We believe that there’s a significant—— 

Senator FRANKEN. Well, you can go to your doctor. 

Mr. BELL. Sure. There’s a variety of methods that we advocate 

for people to get information. One, you know, there are good 

sources available through the Federal Government, through the 

National Institutes of Health. Office of Dietary Supplements has a 

very good Web site, with authoritative information. We think the 

standard should be, you know, what is in the comparative medical 

evidence. Is there comparative reviews of clinical studies—— 

Senator FRANKEN. What percentage of these supplements would 

you say live up to their claims on their labeling? 

Mr. BELL. I would be hard-pressed to answer. I think it’s very 

hard to characterize a marketplace, where you have so many different products. I think there’s a large mass of products that are 

generally fine, and have, you know, good—vitamins, for example; 

you know, most vitamin products state what they contain; they’re 

relatively straightforward products. Many minerals, and even some 

herbal products, have relatively standardized preparations. People 

can consult labels for—the U.S. Pharmacopeia-verified label is anVerDate Nov 24 2008 15:05 Oct 19, 2010 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 H:\DOCS\57983.TXT SAG PsN: JOYCE
85 

other thing people can look for. But, I absolutely agree that consumers should discuss the use of supplements with their physician 

or—— 

Senator FRANKEN. Especially because—— 

Mr. BELL [continuing]. Medical provider—— 

Senator FRANKEN. I don’t mean to interrupt you, but you testified to the interaction between prescription drugs and supplements, 

that, for example, I know I—if you eat grapefruit, that it acts bad 

on statins, right? 

Mr. BELL. Uh-huh. There is really a lot that people need to 

know. In some of the journal articles I cited in my testimony, there 

are lists of as many as, you know, 20 to 30 different supplements 

that could affect cardiovascular health. They can affect it in multiple ways—you know, they can intensify the effect of medications 

people are taking; they can weaken it; they can interfere with clotting and other factors, so they’re—people who could be at risk in 

surgery. So, we provide, you know, through our Web site, information for our subscribers. I know the General Accounting Office has 

recommended the FDA do more to inform and educate consumers. 

But, I would just say, it’s—it is a very large task, because these 

are very complicated decisions. I think that the medical provider 

and the physician has to be a gateway, because someone needs to 

take a look at the medications and the particular supplements that 

the consumer is taking, and make sure that the harmful interactions will not be present. 

In some cases, physicians have also found patients are taking 

supplements that are contaminated, and then they need to send 

that—— 

Senator FRANKEN. Well, as Mr. Cooperman talked about—— 

Mr. BELL [continuing]. Preparation out to an outside lab—yes— 

send it out to an outside lab to see if prescription drugs might be 

present in that product. 

So, I would urge seniors to do their homework. We try to provide 

straightforward information about supplements that we think are 

beneficial. But, I would say there’s relatively few products that we 

recommend. We think there is scant evidence for many, many products, and that—so consumers may be putting their money at 

risk—— 

Senator FRANKEN. Mr. Mister seemed to have a different opinion, 

for some reason. 

Mr. Cooperman—and I’m running out of time here, and I’m 

sorry—you were talking about the contamination. I was picking up 

on Mr. Bell, there. What do you think can be done to improve— 

just—so that seniors are getting at least what they want, that it’s 

at the level of what they want of the stuff that either does or 

doesn’t do what it’s supposed to do, and that they don’t get the bad 

stuff that they don’t want? 

Dr. COOPERMAN. Yeah—— 

Senator FRANKEN. What can be done, do you think? You know, 

is the new law, that Senator Hatch has crafted with Senator Harkin—is that sufficient? Or is there something that you think needs 

to be done on a policy? 

Dr. COOPERMAN. It’s an excellent question. As we see it, one of 

the biggest problems here, as I said repeatedly in my testimony, is 

86 

that there are no quality standards built into the law, neither into 

the GMPs or into the wider DSHEA law. That is left to the—each 

manufacturer, to pick their own standard. Then, within that, 

they’re each allowed to determine their own way of testing against 

that standard; and there are good tests and there are very lenient 

tests. 

So, a first step, really, would be to set some standards, you know, 

rather than just having States go off, like California, and set their 

standards. Perhaps have some type of guidance, if not law, you 

know, from the Government, in terms of standards. I think—— 

Senator FRANKEN. I’m sorry, but we’ve—my time—— 

Dr. COOPERMAN. OK. 

Senator FRANKEN [continuing]. Is up, and I’ve indulged the panel 

enough. Maybe Senator Hatch would either want to pick up on that 

or ask what he likes—— [Laughter.] 

Senator FRANKEN [continuing]. Whatever he wants to ask. 

The CHAIRMAN. Thank you, Senator Franken. 

Senator FRANKEN. Thank you. 

The CHAIRMAN. Senator Hatch? 

Senator HATCH. Well, thank you, Mr. Chairman. I’m grateful to 

my colleague for recognizing that. 

Have any of you ever used dietary supplements? Everybody is 

shaking their head. 

[Witnesses indicating yes.] 

Senator HATCH. You use them today? 

Mr. BELL. Yes. 

Dr. COOPERMAN. Sure. 

Senator HATCH. How about you? 

Mr. BELL. I take a multivitamin. 

Senator HATCH. Multivitamin. I presume you do. 

Mr. MISTER. Took a handful this morning, Senator. 

Senator HATCH. OK. 

It’s Kutz? 

Mr. KUTZ. ‘‘Kootz,’’ yes. 

Senator HATCH. ‘‘Kootz. Kootz.’’ Mr. Kutz. Yes. 

Senator HATCH. ‘‘Kootz,’’ sorry. I wanted to thank you for your 

testimony. I want to ask you for yes/no answers on some questions, 

just to be clear for the record. 

Based on your testimony, you stated that the FDA statutes and 

regulations do not permit sellers to make claims that their products can treat, prevent, or cure specific diseases. Is that correct? 

Mr. KUTZ. Yes. 

Senator HATCH. OK. When you and your staff shared these drugtype claims with the FDA and the Federal Trade Commission, both 

agencies agreed that these, ‘‘drug-type,’’ claims were improper, and 

were in likely violation of the current statutes and regulations. 

Is that correct? 

Mr. KUTZ. Yes. 

Senator HATCH. OK. Finally, from the samples tested, the levels 

of heavy metals found did not exceed any FDA or Environmental 

Protection Agency, or EPA, regulations governing dietary supplements or their raw ingredients. In fact, the FDA and the EPA officials did not express concern regarding any immediate negative 

87 

health consequences from consuming those 40 supplements. Am I 

correct on that? 

Mr. KUTZ. Can I say yes, with a footnote? 

Senator HATCH. Yes. 

Mr. KUTZ. There were 16 that they did not have a tolerance level 

for, although they did say, Senator, that they were very low, based 

on—— 

Senator HATCH. OK. Nobody’s more interested in making sure 

that this industry works properly in the best interests of our people 

than I am. The trouble is, FDA doesn’t have the money to really 

do what it should do. 

Mr. Cooperman, could you please explain a little bit how 

ConsumerLab works? Do organizations hire you to conduct tests on 

their products? 

Dr. COOPERMAN. Right. I believe that Senator Corker just asked 

the same question. 

We have two programs. We go out and do reviews, where we select products, test them, and report all the results. We also have 

a voluntary certification program, where companies can come to us 

voluntarily, just as the USP does and NSF does, and if that product passes that certification testing, we will note that on our Web 

site, as well. 

Senator HATCH. What do you do with those that don’t pass that 

certification testing? 

Dr. COOPERMAN. The ones that don’t pass, that information is 

given to the manufacturer; hopefully, they’ll correct that. 

Senator HATCH. But, you don’t make that public at all. 

Dr. COOPERMAN. The USP does not, as part of that certification 

program; that’s a separate thing from the reviews we conduct 

where all the result are published. 

Senator HATCH. Am I correct that ConsumerLab is a for-profit 

organization? 

Dr. COOPERMAN. That’s right. 

Senator HATCH. If that is the case, what happens when one of 

your clients doesn’t like the results of your tests, and those results 

show that a product may potentially pose a public health risk? 

What do you do? 

Dr. COOPERMAN. Sure. Yeah, I mean, it’s a very good question. 

Senator HATCH. Are these results still made available to the public, for instance? 

Dr. COOPERMAN. Yes, as I just said, in our product reviews—and 

there are many examples from those in the testimony I gave—all 

those results are published. So, there’s no pulling back on any information. What a manufacturer can do is fix it later. As I said, 

we have a published protocol, where any manufacturer can come 

to us and, for free, not only get the results, but we would even send 

out their sample to another laboratory, of our mutual choosing, if 

they wish to challenge those results. 

Senator HATCH. Are your lab tests and your findings peer-reviewed by scientific experts outside of your organization? 

Dr. COOPERMAN. Our Web site is not a peer-reviewed Web site. 

Dr. William Obermeyer, who is from the FDA, chooses these laboratories. There all accredited laboratories. In fact, going even beyond what the GAO is able to do, any product that fails our tests 

88 

is sent to a second independent laboratory for confirmation before 

we would even publish those results. 

Senator HATCH. OK. Do you have an auditing program for all the 

labs that you use, to ensure the accuracy and reliability of the results you’re giving? 

Dr. COOPERMAN. Right. I can have Dr. Obermeyer speak more toward that. It would be helpful, perhaps, if the FDA actually regulated the laboratories—they do not—in terms of the dietary supplements. 

Senator HATCH. Well, they have the authority to. But, again, 

we—we’re responsible, too, for not providing the money so that 

they can do a better job. 

Mr. Mister, I just—I’m—— 

Mr. Bell, I’m not trying to ignore you, I may get to you. 

But, Mr. Mister, let me ask you this. In Mr. Cooperman’s testimony, he said that Current Good Manufacturing Practices—or 

GMPs, we call them—CGMPs—can still allow bad products on the 

market, because the CGMPs do not include standards for purity 

and ingredient identity. Is this a loophole that allows unsafe products on the market? Can you give the committee some reassurances, here? 

Mr. MISTER. Well, it’s certainly not a loophole, Senator. The GMP 

regulations do give individual companies some flexibility, when 

FDA comes to inspect, to demonstrate how their product identity 

matches to a standard, to prove that it is what it says it is. 

Senator HATCH. Yeah. 

Mr. MISTER. But, it does leave some flexibility to the company. 

However, that’s not to say that the company can just pick any 

standard they want, the standard must be scientifically defensible 

to FDA during that inspection. Just saying, ‘‘We looked at the product and it looked like Vitamin D to us,’’ is certainly not going to 

pass muster. 

So, companies have to develop standards and use testing that 

FDA would agree to. 

Senator HATCH. OK. 

Mr. Bell, are you familiar with the Bioterrorism Act of 2002, and 

that it requires mandatory registration of all food facilities, including dietary supplement facilities? 

Mr. BELL. Yes, I am aware that law has been passed. However, 

we are concerned that it does not provide the same detail and 

amount of information that could be available through expanded 

manufacturer registration requirements. 

Senator HATCH. Have you ever completed this registration and 

seen that you can click a box to identify oneself as a dietary supplement manufacturer? 

Mr. BELL. I have—I—Senator, I have not seen that registration 

form itself. But, my—our concerns were based on the HHS inspector general report that found that FDA often—you know, 30 percent of the time—did not have information on how to contact manufacturers who had submitted adverse event reports, and they, 60 

percent of the time, did not have ingredients of products that they 

were investigating. I certainly hope that situation has improved. 

But, we would support strengthening manufacturer registration to 

the same level for monograph drugs. 

89 

Senator HATCH. Mr. Chairman, could I ask one more question? 

I notice—— 

The CHAIRMAN. Sure, go right ahead, Senator Hatch. 

Senator HATCH. I’ll finish with this last—— 

I noted, in—Mr. Bell, in your testimony, that Consumers Union 

supports S. 3002, the Dietary Supplement Safety Act of 2010. As 

you may know, consumers of dietary supplements let Senator 

McCain know that they had serious concerns with this bill, because 

it could jeopardize the availability and affordability of dietary supplements. 

Senators Harkin, Enzi, and I worked with Senator McCain and 

Senator Dorgan to incorporate four concepts from this bill into S. 

510, the Food Safety Modernization Act. Now, these concepts include mandatory registration of facilities, mandatory recall of dietary supplements, publication of new dietary ingredients, or NDIs, 

guidance in mandating the FDA to notify the DEA when a ‘‘new 

dietary ingredient’’ application is rejected because the product contains an anabolic steroid. 

Now, the last two concepts were introduced in the legislation 

that Senator Harkin and I introduced yesterday. So, I would hope 

you—that would please you. 

Now, could I ask you one thing? Does the Consumer Union—does 

it put out a list of pharmaceuticals that—with a cross-list—what 

dietary supplements may be harmful or may have—— 

Mr. BELL. Yes, sir, we do. I actually have it with—here with me, 

if you’d like—— 

Senator HATCH. Well, I’d love to have that, if you’d be—— 

Mr. BELL. Sure. Sure. 

Senator HATCH [continuing]. Could get that to my office. 

Mr. BELL. Absolutely. I—— 

Senator HATCH. I’d love to look that over as part of, you know, 

our total desire, here, to get this industry doing everything it can 

to be right. By and large, the vast majority of them, as you’ve indicated, put out pretty good products, that work, and—you know. 

But, we have some bad actors, too, and we’ve got to get those, and 

get them out of this business, because nobody—Mr. Mister, you 

don’t want any bad products in this industry. It hurts everybody. 

Mr. MISTER. Absolutely. 

Senator HATCH. So, we need everybody working on it; but, more 

importantly, I’ll hope you’ll all advocate that we, in Congress, do 

our job by giving enough money to FDA to really look into these 

matters and do the job that DSHEA and these other bills that we 

have passed direct them to do. For example, it took well over 10 

years to get GMPs, and they’re still not done. So, Good Manufacturing Practices are still not done. We’ve been beating up the FDA 

for years to get that done. Part of the problem is money, and part 

of the problem is our fault, up here on Capitol Hill. 

We’re all concerned about the aged and those who rely on dietary 

supplements. Most of the aged I know do, and they feel much better because they do. So, we want to make sure that they’re goodquality products and that they will continue to help people who are 

aging, with the problems they might have. 

Thank you, Mr. Chairman. Sorry I took so long. 

The CHAIRMAN. Thank you very much, Senator Hatch. 

90 

Mr. Mister, I’m sure that you represent an industry that wants, 

in every possible way, to be clean and above board and beyond reproach. I believe that’s your goal. So, we—the GAO has done some 

investigation and uncovered products that may very well be misleading, in terms of what they claim. They’ve given their information to the FTC and the FDA. 

In the event that the FTC and the FDA conclude that what GAO 

uncovered is basically true, I would think, then, that you, your 

trade organization, and your industry would want those who transgressed to be made public, and for everybody to understand and 

know, not only for the public’s sake, but also as a lesson to those 

who would do wrong and, in the process, harm your industry. 

Mr. MISTER. We’ve been a strong advocate for transparency in 

the enforcement actions, and also for increasement in the enforcement actions. 

The CHAIRMAN. Good. 

Mr. MISTER. So, we would absolutely support FDA and FTC investigating any of the claims that have been made today, because 

the vast majority of the industry, who are doing things right, they 

want a level playing field. They are disadvantaged—— 

The CHAIRMAN. That’s good—— 

Mr. MISTER [continuing]. If there are rogue players out there on 

the fringes doing something wrong and misleading consumers. 

The CHAIRMAN. That’s—no, that’s very good. 

Mr. MISTER. Our goal is to increase—— 

The CHAIRMAN. I just want to ask Mr. Kutz—again, those two 

bottles that you have in—at the desk, tell us again what they 

claim, very clearly, the one and the other? 

Mr. KUTZ. The garlic ‘‘prevents and cures cancer,’’ and the 

other—— 

The CHAIRMAN. It what? Say it again, loud. 

Mr. KUTZ. ‘‘Prevents and cures cancer.’’ 

The CHAIRMAN. Wow. 

Mr. MISTER. 

What does the other one say? 

Mr. KUTZ. This ‘‘reverses the effects of a stroke.’’ 

The CHAIRMAN. Mr. Mister. Mr. Mister. [Laughter.] 

Now, I know—I know how hard it is. I’ve been in business all 

my life, and I understand how it’s hard to be 100 percent. So, this 

is not personal or wanting to be overly critical. But, at least on the 

basis of what he says there, believing he’s representing what’s on 

the labels, that’s pretty shocking, isn’t it? 

Mr. MISTER. It’s very disturbing, Senator. Those claims are illegal and most likely untrue. 

The CHAIRMAN. Now, doesn’t your trade association have a way 

of seeing to it that those things don’t occur? 

Mr. MISTER. Well, I can say with relative certainty, Senator, that 

the manufacturers of those products are not our members. We’re a 

trade association, we’re not a police organization. So, we can’t police the industry for companies that are not our members. 

The CHAIRMAN. I see. 

Mr. MISTER. But, certainly, we use our trade association, and the 

other four associations in the industry, likewise, use theirs, as a 

soapbox to preach what companies should do, and then to urge 

91 

companies to do the right thing, to recognize companies that do, 

with certifications programs, and then to hold up those who don’t, 

through programs like our NAD program, to public scrutiny. So, we 

do as much as we can as a trade association. At some point, we 

have to rely on the enforcement agencies, like FDA and FTC to do 

their jobs, too. 

The CHAIRMAN. Very well said. 

Senator CORKER. 

Senator CORKER. Mr. Mister, what kind of process would a company go through at the FDA to make sure the claims that my product was making were actually valid? 

Mr. MISTER. Well, the first thing you would have to do is register 

your facility, wherever you are making the product or storing it, 

under the Bioterrorism Act. They are already required to have a 

onetime registration. The Food Safety legislation would increase 

that to an annual registration, and the industry is on record supporting that. 

The second thing you would do is, you would have to notify FDA 

of the claims you are making. Depending on the kind of claims they 

were, there are different levels of scrutiny. If it is what’s called a 

‘‘structure function claim,’’ which means you’re simply saying that 

this has some affect on the normal function of the body, like maintaining a healthy immune system, then you’d have to notify them 

within 30 days of marketing the product. If you’re going to make 

a claim that you help to reduce the risk of a disease, then you’re 

a ‘‘health claim,’’ and you actually have to submit evidence to the 

agency, and they have to give you approval to make that claim. 

Then the third thing you do is on the ingredients. Regardless of the 

claims you make, if you’re bringing a new dietary ingredient to 

market that was not on the market prior to 1994, you also have 

to give FDA a notification 75 days before when you want to bring 

the product to market. You have to submit evidence to the agency 

that there is a reasonable basis for the expectation of safety of the 

ingredient. 

Senator CORKER. So, the claims that one would make on a label 

would be claims that, assuming everything worked properly, the 

FDA would have had to validate that product actually does that. 

Is that correct? 

Mr. MISTER. If the law were working properly, those claims 

would have been submitted to FDA, and FDA would know that 

they were out there. 

Senator CORKER. So, in essence, the fact that these two products 

were sold—and, while that hurts your industry and y’all are selfpolicing and not really charged with making sure that these things 

occur—the fact is, the FDA and the FTC should have caught that. 

Is that correct? 

Mr. MISTER. We would like to see those cases prosecuted. I mean, 

as—— 

Senator CORKER. But, should—— 

Mr. MISTER. We put an awful lot of attention on garlic and ginseng and ginkgo today—— 

Senator CORKER. But, are these—— 

Mr. MISTER [continuing]. Which disturbs consumers. 

92 

Senator CORKER [continuing]. Are these issues that those two organizations should have caught? I mean, who polices that? 

Somebody behind you is shaking their head, ‘‘No, no, no.’’ So, 

who—I don’t know which one of you is right, but who, in fact, is 

supposed to—— 

Mr. MISTER. Well, the question is, you know, How many resources does the agency have to police everything that’s on the 

Internet? You know, some of the—— 

Senator CORKER. Well, no, no. No—— 

Mr. MISTER [continuing]. Some of the products—— 

Senator CORKER [continuing]. No, no. No, that’s not the question. 

The resource issue is one I know that Senator Hatch has mentioned earlier, but under whose jurisdiction is it to actually ensure 

that somebody’s not out there selling products that are making 

claims that are not warranted? 

Mr. MISTER. Well, it depends, Senator, on whether the claim is 

made in the form of advertising or made in the form of labeling. 

FDA has jurisdiction over the labeling. FTC has jurisdiction over 

the advertising. The interesting thing about—— 

Senator CORKER. So, in these cases, these were labels, and so, 

that would have been the FDA’s responsibility. So, they’re not carrying out their responsibilities in that regard. Is that correct? 

Mr. MISTER. Yes, sir. 

Senator CORKER. So, it’s—but—and again, I’m not trying to shift 

blame—it’s not really your responsibility. Y’all do that because you 

want your industry to be healthy. A lot of industries set up organizations like yours to ensure that’s the case. But, it’s really FDA’s 

responsibility, ultimately, to do the real policing. Is that correct? 

Mr. MISTER. Yes, sir. They have—they’re the ones that have the 

regulatory authority. 

Senator CORKER. Mr. Bell, Senator Hatch asked you the question 

about his legislation and the four points that were added in trying 

to accommodate, I guess, and to get to a place where there’s a lot 

of support. He asked you if you, in fact, supported his legislation, 

in its form, or whether you thought other actions were necessary. 

You didn’t really respond. I think he was trying to lobby for your 

support, and you didn’t answer. So, I’m asking. 

Mr. BELL. Well, thank you, Senator. You know, we’ve just had 

a chance to look at the bill that came out. On the four points that 

you mentioned, those are points that we support, and we’re pleased 

to see that there is emerging agreement around those four points. 

I guess we had also been concerned that we would like to see expanded reporting of the nonserious adverse events for the mild and 

moderate events that are required to be reported for prescription 

drugs and over-the-counter drugs. 

We think that those should be reported for dietary supplements, 

as well, because it would give FDA a much fuller record to warn 

the public about emerging safety problems. 

In the recent Hydroxycut recall, where—or the removal from the 

marketplace—the public never got any information, even though 

the FDA had received about 72 serious, you know, adverse-event 

reports about that product. So, we would like to see more transparency and realtime information flowing to consumers, because 

93 

we think consumers are put at risk when that information is not 

there. 

The FDA estimates that there’s about 50,000 adverse events taking place related to dietary supplements each year, but GAO said, 

under the expanded reporting of serious events, we only got about 

900 reports to FDA last year. So, there’s a lot more information out 

there that could potentially be helpful for—to consumers, in our 

opinion. 

Senator CORKER. So, to educate a layman and others who may 

be tuning in, give me an example of one of those types of events 

that you would like for consumers to know about. 

Mr. BELL. Well, it could be things like headache or temporary 

nausea. The standard for the serious event is really something that 

puts consumer in a hospital, that maybe causes organ damage or 

a stroke. You know, it’s a pretty high level of medical events that 

require some sort of detailed intervention. But, there’s a lot of 

other types of events that consumers may experience and complain 

to manufacturers about that would be useful for FDA to know. 

Senator CORKER. So, Senator Hatch may respond to this himself, 

but, these are the types of things, I guess—when we all see advertising with pharmaceuticals; they’re always talking about the disclaimers and the minor things that may occur if you take this, that 

are sort of side-effects. Would that be something that would be difficult for the industry, if it was added in to the legislation he’s talking about, that component? 

Mr. BELL. You know, I think that’s—given that the prescription 

drug companies are able to deal with it, it is a reasonable requirement. The reporting requirement is actually just an annual requirement; it’s not the 15-day requirement. So, it’s—and they 

maintain records in their offices. So, we think this would strengthen the safety profile, because we’re mostly catching problems after 

the fact with these products, given that there wasn’t a lot of premarket safety testing for them. We think having a fuller information base would really be helpful both for the agency and for physicians around the country. 

Senator CORKER. So, Mr.—I hate to call you this. I’m going to 

call you Steve Mister. The other sounds so odd. What is your response to that? I mean, is that a burden on the industry, for that 

additional portion that Mr. Bell is referring to, to be added in? 

Mr. MISTER. Well, first of all, I want to correct something that 

was said earlier. Over-the-counter drugs are subject to the same 

adverse-event reporting requirement as dietary supplements. So, 

they only report their serious adverse events, as well. Both of those 

categories were in the same—— 

Senator CORKER. Say that one more time. 

Mr. MISTER. Over-the-counter drugs only report their serious adverse events. I think Mr. Bell said that they have to report their 

mild and their moderate. Senator Hatch introduced this legislation 

several years ago, on the Adverse Event Reporting Law, and it 

holds dietary supplements to the same standards as over-thecounter drugs when it comes to reporting your adverse events. 

But, second, when the GAO—— 

Senator CORKER. Hold on—let me—so, just to close this loop— 

Mr. Bell, so—— 

94 

Mr. BELL. Yeah. No, he’s correct, I did misspeak. So—— 

Senator CORKER. So—just out of curiosity—why would you want 

the dietary portion to have a higher standard than over-thecounter? 

Mr. BELL. Well, we are concerned about the—I think the drug 

interaction issues is another huge component of this, that—it’s—— 

Senator CORKER. Well, would that same—— 

Mr. BELL [continuing]. Largely—— 

Senator CORKER [continuing]. Be true, though, with over-thecounter? 

Mr. BELL. Over-the-counter has additional premarket safety requirements that they need to make, so there are—we think there 

are fewer hazards of the type that we see in the dietary supplement world. Again, you know, the difference between 900 reports 

and 50,000 reports is a pretty big gap, in our opinion. 

Senator CORKER. Yeah. 

Mr. BELL. So, we would like to see a larger base of information 

collected. We don’t think it’s an inordinate burden on the industry, 

which doesn’t spend a lot on safety testing for these products. 

Senator HATCH. Would you yield—— 

Senator CORKER. Yup. 

Senator HATCH [continuing]. For just one comment, Senator—— 

Senator CORKER. Yes, sir. 

Senator HATCH [continuing]. On this issue? 

It is true that—I think Mr. Mister could help us to understand— 

it is true that, even though you report the serious adverse events, 

you have to keep track of all of the adverse events that come in. 

Mr. MISTER. That’s correct. We have to keep—— 

Senator HATCH. That’s similar—— 

Mr. MISTER [continuing]. Them for 6 years. 

Senator HATCH [continuing]. To the pharmaceutical industry, as 

well. 

Mr. MISTER. Yes, sir. 

Senator HATCH. OK. I mean, that’s something I think people 

just—— 

Senator CORKER. But—— 

Senator HATCH [continuing]. Don’t realize. 

Senator CORKER. But, would this additional requirement that 

Mr. Bell would like to see—— 

Thank—no, thank you. 

Would that additional requirement be a large burden to the industry? 

Mr. MISTER. It would be a burden on the industry, but, more 

than that, it would be a burden on the FDA. The interesting thing 

is that, when the GAO report came out last year making that recommendation, that it—we should be reporting not just serious adverse events, but all adverse events, FDA responded, at the time, 

saying that they don’t have the resources to process that kind of 

information. It’s enough for them to have to process the serious 

ones that come in from drugs and supplements and OTCs. To increase that to every time somebody called because they had a headache or thought they had a freckle that was—— 

Senator CORKER. Yeah. 

95 

Mr. MISTER [continuing]. Related to their supplement, you can 

imagine how that would—— 

Senator CORKER. But, let’s move away from—— 

Mr. MISTER [continuing]. Multiply the number of events. 

Senator CORKER [continuing]. The FDA, in that I think the 

issue—Senator Hatch has talked about the funding of FDA, and I 

have a sense he’s gonna want to address that through appropriations and other efforts. Let’s move that aside and just talk about 

the industry itself. 

From the standpoint of the industry, if the FDA had those resources, would that issue be something that, on the industry itself, 

is an undue burden? 

Mr. MISTER. It would be a burden, Senator, because the way the 

standard is, is, if the adverse event is associated with the supplement, then the manufacturer turns it over. There’s not a causality 

standard. The manufacturer does not have an opportunity to evaluate whether they really think it’s connected to the supplement. If 

the consumer says it’s associated, they have to turn it over. 

So, there is a large number of consumer complaints and calls 

that come in to any industry where consumers have questions or 

say, ‘‘Well, I think maybe I got a little bit of a headache or something,’’ or, ‘‘It didn’t taste quite right in my mouth as it went 

down.’’ All those kinds of things would be considered mild adverse 

events. You can imagine, that’s quite a burden on a industry, to 

say, ‘‘You must report all of those within 14 days.’’ 

Senator CORKER. This is my last question. I thank you for the 

time, Mr. Chairman, and certainly thank all of you for coming. As 

Senator Hatch has said, the industry itself is something that I 

think is important, and certainly want to make sure that it flourishes, but, at the same time, has proper checks and balances, so 

that consumers are protected. That’s good for the industry, too. 

I understand the gentleman who was shaking his head vigorously in the background is our next witness, the FDA, or part of 

the FDA, saying that, in fact, it is not their responsibility, if his 

body language is correct, to actually check these labels. Before you 

leave the dais do you want to say anything else about that? Apparently he feels 180 degrees the opposite. I find that kind of odd. 

Mr. MISTER. Well, maybe he and I are interpreting the question 

differently. Do they have a legal obligation to prereview that label 

before it gets on the market? The answer to that, I would agree, 

is no. But, if there is a product out there making those claims, and 

it’s brought to the agency’s attention, then absolutely they have authority to enforce the law and to prosecute that company. 

Senator CORKER. So, if I want to make a product that does, 

whatever, I can make that product and make those claims and put 

it on the label, and there’s no preapproval process as to whether 

that’s valid, or not. 

Mr. MISTER. There is no preapproval process—— 

Senator CORKER. It’s only if somebody complains or somebody—— 

Mr. MISTER. You do that at your peril, and we hope the FDA 

would bring its resources to bear and enforce against that company. 

Senator CORKER. I find that to be kind of odd, but I’ll move on. 

96 

The CHAIRMAN. Yeah—I—we want to move on, because we have 

the deputy commissioner of the FDA here. 

But, I just want to reenforce what he said. I used the word ‘‘odd.’’ 

Again, I know how hard it is to be perfect. I’ve been in business 

all my life. But, there should be, hopefully, some mechanism 

whereby those who make false claims—even though they don’t belong to your organization, inasmuch as you represent all the major 

players, or most of the major players—those who make false claims 

and stain the industry, there should be some way in which you can 

shame them into taking their products off the shelf. If nothing else, 

notify the FDA. I mean, there’s some way. 

Mr. MISTER. Yes, Senator, we do that. We have written to the 

FDA, on any number of occasions, when we are aware of these 

kinds of products or these claims that are being made. 

The CHAIRMAN. OK. All right, so let’s move on now to the—— 

Senator HATCH. Mr. Chairman, can I—— 

The CHAIRMAN. Oh, yes, go ahead, Senator Hatch. 

Senator HATCH. There is no formal obligation for FDA to check 

before the product is made, and the—but, there is a tremendous liability if you represent—and tell me if I’m wrong, Mr. Mister— 

there’s tremendous liability if you misrepresent what’s on that 

label. 

Mr. MISTER. We should never forget that the Food and Drug Act 

is, at its heart, a criminal statute. So, there are criminal sanctions 

for misbranding or mislabeling a product. 

Senator HATCH. Yes. 

Now, Dr. Cooperman, I just want to understand the service you 

provide to dietary supplement manufacturers. For those companies 

that pay ConsumerLab to test their products, if unsatisfactory results are found, do you still make those results public? 

Dr. COOPERMAN. We—— 

Senator HATCH. For people who pay? 

Dr. COOPERMAN. Yeah, as I said before, we have a certification 

program, a voluntary certification program, and we have our product reviews. The way that the certification program operates is the 

same as the way that the USP operates its certification program, 

which is, a company comes to you voluntarily, pays a testing fee, 

you run it through all the rigorous tests that you see as appropriate—which are the same we use for the ones that we select on 

our own—and in that voluntary program, if it is certified, we will 

publish that. Those results are the property of the manufacturer, 

so they can do what they want with those results. 

Senator HATCH. But, you don’t make them public, though. 

Dr. COOPERMAN. No, those are those results. Those are their results, just in the USP program. 

Senator HATCH. I just wanted to make that clear. 

Dr. COOPERMAN. Right. 

Senator HATCH. Mr. Mister, one last question. Would you just 

talk to us about the outreach efforts your industry has made to 

consumers so that they might have more information about dietary 

supplements? Also, what type of education could be provided to better educate medical professionals to prevent bad interactions between drugs and dietary supplements? 

97 

Mr. MISTER. I think all of the associations have various programs 

that do outreach to consumers. At CRN, we have a program called 

‘‘Life Supplemented.’’ We have our own Web site, and we try to 

educate consumers, through the Web site, that dietary supplements 

are not a magic bullet. They are not a magic cure for any disease. 

They are part of an overall wellness regimen. They should be incorporated into your lifestyle, along with diet, exercise, seeing a doctor 

regularly, getting a good night’s sleep, all of those kinds of healthy 

behaviors. So, that’s one of the things that we’re doing at CRN. 

When it comes to medical professionals, again, we have funding 

issues, just like the government does. We would like to see more 

emphasis being placed in pharmacy schools, in medical schools, to 

teach these would-be doctors and pharmacists more about the use 

of supplements, both the benefits and then the interactions. Supplements can also have positive interactions and can be used to 

augment drug therapy. So, we’d like to see that done. 

We’ve also done continuing education with both nurse practitioners and pharmacists, to educate them on some of these issues. 

Again, with more funding, we could do more of that. 

Senator HATCH. Thank you, Mr. Chairman. 

The CHAIRMAN. OK, thank you, everyone. 

Just one—Mr. Kutz, the manufacturers of those two labels, are 

they obscure manufacturers, or—what’s on the label? 

Mr. KUTZ. They would be—do you want me to read them to you? 

The CHAIRMAN. Pardon me? 

Mr. KUTZ. You want me to read the labels to you? 

The CHAIRMAN. You ever heard of that name, Mr. Mister? 

Mr. KUTZ. You want me to tell you, I mean? 

Senator CORKER. He, yes, wants you to read it. 

Mr. KUTZ. All right, the first one is American Ginseng capsules, 

and the second is 88herb.com garlic powder. 

The CHAIRMAN. You’ve never heard of those companies, Mr. Mister? 

Mr. MISTER. No, sir. According to the law that Senator Hatch 

helped pass, there should be a name of a company and an address 

on the label. 

The CHAIRMAN. That’s what I was—that’s what I was wonder— 

that’s what I was asking Mr. Kutz. 

Mr. KUTZ. You want to know? 

The CHAIRMAN. Yeah. [Laughter.] 

Mr. KUTZ. Sure. The first one is Marathon, WI. 

The CHAIRMAN. Oh my God, that’s my State. [Laughter.] 

Mr. KUTZ. That’s why I asked you twice. [Laughter.] 

The CHAIRMAN. Forget it. Forget the whole thing. I never asked 

anything. [Laughter.] 

Senator HATCH. Most of your players are taking them—— 

[Laughter.] 

Senator CORKER. I think that’s his uncle. So. [Laughter.] 

Mr. KUTZ. The second one, I think it came from overseas. We 

can’t tell for sure. 

The CHAIRMAN. You’ve not heard—I mean, that those—those are 

names that you’ve not heard of. 

Mr. MISTER. No, sir. 

The CHAIRMAN. OK. 

98 

Senator CORKER. Can I—— 

The CHAIRMAN. Go ahead. 

Senator CORKER. What is a standard? You talked about the 

criminal process if somebody makes a claim. What standard is it 

that one uses in trying to establish criminality in that regard? 

Mr. MISTER. It’s a strict liability standard under the Food, Drug, 

and Cosmetic Act. So, if you say it, you’re responsible for it. 

Senator CORKER. So, based on what you’re saying, these two companies would—based on what you’re saying, these companies would 

have been liable to undergo criminal proceedings? 

Mr. MISTER. Yes, sir. Not only the companies themselves, but the 

officers of those companies can be prosecuted as misdemeanors. 

Senator CORKER. Do you know if that occurred? 

Mr. MISTER. In this case? I don’t. 

Senator CORKER. OK. 

Senator HATCH. It’s been a good—— 

The CHAIRMAN. Thank you very—— 

Senator HATCH [continuing]. Good panel. 

The CHAIRMAN. Go ahead. 

Senator HATCH. It’s been a good panel. 

The CHAIRMAN. Thank you very much. Been a great panel. We 

appreciate your coming, and you’re now excused. 

We’re calling the next panel, Dr. Joshua Sharfstein, who’s the 

Deputy Commissioner of the FDA. 

Are you happy you’re here, Dr. Sharfstein? [Laughter.] 

[Pause.] 

The CHAIRMAN. All right, Dr. Sharfstein went to Harvard Medical School, and he was formerly the Commissioner of Health for 

the city of Baltimore. As I said, he’s now the Deputy Commissioner 

of the FDA, second ranking individual in that very important commission. 

So, we’re happy you’re here. Please limit your comments, maybe 

to 5 minutes, so we can have enough time to dialog with you. Go 

right ahead, sir. 

STATEMENT OF JOSHUA SHARFSTEIN, DEPUTY COMMISSIONER, FOOD AND DRUG ADMINISTRATION, SILVER 

SPRING, MD 

Dr. SHARFSTEIN. Great. Thank you very much, Chairman Kohl, 

Senator Corker, Senator Hatch. I very much appreciate the opportunity to be here with the committee. 

I am Dr. Joshua Sharfstein, the Principal Deputy Commissioner 

of the U.S. Food and Drug Administration, an agency of the Department of Health and Human Services. 

Thank you for the opportunity to discuss FDA’s role in the regulation of dietary supplements, as well as the findings of the study 

on botanical dietary supplements by the GAO. 

As you’ve heard, modern FDA oversight of dietary supplements 

began with the 1994 enactment of the Dietary Supplement Health 

and Education Act. This regulatory system now includes the following key elements: 

First, prior to its marketing, the manufacturer of a dietary supplement is responsible for ensuring the supplement is safe. Manufacturers register their facilities, but not their products. 

99 

Second, manufacturers are only permitted to make certain types 

of claims, and may not make false or misleading claims of any 

time—of any kind. After marketing, for most products, companies 

notify us of the claims. 

I apologize for shaking my head. Dr. Hamburg has told me I 

should not give up my day job to become a poker player. [Laughter.] 

But, I think you got it all sorted out, that people tell us about 

the claims after they start marketing. They don’t give us the substantiation. There’s not a review, before marketing, by the FDA. 

Under no—under only very rare circumstances are companies permitted to make disease-related claims. 

Third, manufacturers must abide by good manufacturing practices, which have—are now in effect for large- and medium-sized 

firms, and shortly will be for small firms. 

Fourth, manufacturers must submit to FDA all reports of serious 

adverse events associated with the product that are manufactured. 

We—as—through our agency program performance initiative, 

called FDA Track, will be posting, monthly, how many reports like 

this we get, and from how many firms. As part of our transparency 

initiative, we have proposed making—the idea of making specific 

information about those complaints, along with disclaimers about 

the limitation of those information, available over the Internet. 

We’re now taking public comment on that proposal. 

Fifth, a manufacturer must submit a notification to FDA before 

it markets a dietary supplement containing a new dietary ingredient. We do get some of those notifications now. Also, through 

FDA Track, we will be telling the public, every month, how many 

we’re getting, and whether we’re able to review them within the 

period of time that we need to. In addition, we’re working on guidance that, hopefully, will make it possible for us to get a lot more 

of those notifications. 

Let me, next, turn to our enforcement priorities, because I think 

you heard very clearly wide agreement—I met extensively with industry and others—wide agreement that FDA’s enforcement role is 

extremely important under DSHEA. 

We enforce by reviewing adverse-event reports, we obtain information from inspections, we review consumer and trade complaints, we perform laboratory analyses, and we monitor retail outlets, including the Internet. We also monitor product information. 

We work closely with the FTC, which is responsible for advertising. 

Currently, we focus on three main areas: 

First, adulteration with drug substances. Products that are marketed as dietary supplements, but contain active ingredients in 

FDA-approved drugs, analogs of approved drugs, and other compounds that do not qualify as dietary ingredients, present an 

emerging and expanding challenge, particularly in three areas: sexual enhancement products, weight-loss products, and bodybuilding 

products; also, I would say, in some cases, cholesterol products. 

These products are often sold with misleading labeling, and are frequently manufactured without quality controls. 

Enforcement in this area is challenging. Nonetheless, in the last 

2 years, FDA has participated in the voluntary recall of many dozens of tainted supplement products, including more than 50 sexual 

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enhancement products, more than 40 weight-loss products, and 

more than 80 bodybuilding supplements, by two distributors, alone. 

We’ve issued multiple consumer alerts and press announcements 

to warn consumers about hazardous products. These include four 

warnings about firms marketing sexual enhancement products, 

multiple consumer alerts about 70 tainted weight-loss supplements, 

and a public health advisory about bodybuilding products that are 

represented as containing steroids or steroid like substances. 

We have also participated in seizures and criminal prosecutions 

to disrupt the distribution of illegal products, including two civil 

seizures of illegal sexual enhancement supplements in 2009, two 

individuals arrested for illegally trafficking weight-loss supplements, and multiple search affidavits on firms marketing 

bodybuilding products that were represented as containing steroids 

or steroidlike substances, with one manufacturer pleading guilty. 

Second major area of our focus is illegal claims, and you’ve heard 

about some illegal claims from GAO today. This is an important 

area of enforcement for FDA. We are concerned that unsubstantiated and illegal claims that—for—such as the one you heard, 

about cancer—can encourage consumers to self-treat for a serious 

disease without the benefit of medical diagnosis. FDA conducts a 

number of enforcement activities against supplements that make 

these type of claims, and in the last several years, have issued, you 

know, hundreds of enforcement actions against these types of products. 

Most recently, we really focused on illegal claims around H1N1, 

because we were very concerned that people wouldn’t get the appropriate treatment for flu. We worked jointly with other agencies, 

and wound up issuing warning letters to about 70 supplement 

manufacturers for illicit claims. We even did a first joint FDA and 

FTC advisory letter. 

We appreciate the help of the GAO in this effort, the help of the 

committee by having this hearing, and the help of the industry by 

their efforts to really try to clamp down on these types of claims. 

The third major area of focus is unsafe ingredients. A dietary 

supplement is adulterated if it bears or contains any poisonous or 

deleterious substance that may render it injurious to health, if it 

presents a significant or unreasonable risk. We can ban a dietary 

supplement if it is an imminent hazard. We have taken these sorts 

of actions against dietary supplements that concern us. 

Very briefly, let me mention the GAO study, which you heard at 

length about. In general, there were a number of claims that they 

found that were illegal claims. We just got, I believe in the last 

couple days, the referral from GAO, where they actually named the 

companies, and we will, in fact, investigate and take action if we 

find those to be still in effect. 

They also analyzed, as you heard, 40 dietary supplements for 

heavy-metal contaminants. I think, given the expected generally 

small consumption of the supplements, we do not believe these levels represent a significant risk to health. For example, the cadmium levels reached to about 1.4 micrograms per day. This compares to FDA’s tolerable daily intake level of 60 micrograms per 

day. 

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The lead levels reached to 1.9 micrograms per day, which is 

about a third of the FDA’s tolerable daily intake. This is not a dangerous level, but it does represent a reasonable fraction of daily intake, and we believe it’s possible that preventive standards, of the 

type authorized by the pending food safety legislation, could help 

FDA and supplement manufacturers keep the lead levels as low as 

feasible. 

Recently, FDA and the New York City Health Department identified lead in a dietary supplement at a level of 1100 parts per million. We immediately notified the public of a potential risk, and the 

manufacturer recalled the supplement. 

You also heard about the pesticide residues. There were 41 residues found, none of which FDA believed posed a threat to health. 

Most of them—seven of them were in—within EPA tolerances for 

dietary supplements, 31 were within tolerances used for fruits and 

vegetables, but there was no tolerance set for the dietary supplement. For example, there was a one that was found at .01 parts 

per million in Echinacea, but the residue levels are allowed at 15 

parts per million for celery and 5 parts per million for tomatoes. 

So, in terms of—there was a legal violation, but it wasn’t—it was 

something that was well within what we would see in a fruit or 

vegetable. 

Then, a couple others were for pesticides that are not permitted 

on any food right now in the United States, but are also at very 

low levels and within what, for example, the European Union permits. 

We do have a program where we routinely test supplements for 

pesticides, and we—it leads to recalls, if we find a problem. 

So, let me stop there, and thank you for the opportunity to discuss FDA’s activities on dietary supplements. We look forward to 

working with you and answering your questions. 

[The prepared statement of Dr. Sharfstein follows:] 

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The CHAIRMAN. Dr. Sharfstein, as a former commissioner of 

health with city of Baltimore, and as a current Deputy Commissioner of the Food and Drug Administration, right now, before a 

prescription drug goes to market, it has to be authorized and 

OKed. That’s not true of dietary supplements, as you know. You 

have a recall, but they don’t have to be examined and authorized 

and OKed by the FDA or any other authority. Are you satisfied, at 

least at that point, that what we’re doing is the right thing? 

Dr. SHARFSTEIN. Well, I think that the framework for—that 

DSHEA puts on dietary supplements is very different than prescription drugs. Congress’s thinking about dietary supplements was 

very different than the framework for prescription drugs. The way 

I think about DSHEA is that it balances access against risk. There 

is a very clear feeling in the law, like Congress and the public, that 

they want access to supplements that they—that are important to 

people, and many people in the United States, and so that people 

can put them on the market without a prereview by FDA, and particularly for the products that have been marketed, historically. 

That’s not the case at all for drugs. 

On the other hand, there are provisions in the law that mitigate 

risk. So, you could have a situation where, you know, you only care 

about risk and it’d be very hard to have access, or you could say, 

‘‘We will let everything on there,’’ and there would be no risk provisions. But, I think DSHEA tries to strike a balance. 

FDA needs to do a few things to maximize the risk part of the 

equation, I think, from what the law permits. That includes getting 

out the guidance on the new dietary ingredients. We have to do our 

enforcement, like you’ve heard. We need to fully implement the 

Good Manufacturing Principles. 

I think, as you think about that balance—the question is, Are we 

striking the right balance? I think, for the most part, the answer 

to that is yes. 

The area where I think—that gives the FDA the most concern 

with that question relates to the pharmaceutical spiking of dietary 

supplements, because we’re talking about very serious risks and injuries that can happen to people. Often they’re, you know, young 

people who don’t really understand and they’re—that they’re taking what are actually prescription drugs or steroids through dietary 

supplements. There has been testimony by FDA, that while we are 

at—being as aggressive as we can with enforcement, we are very 

concerned about the state of the market for these products. I think 

that’s the area that gives us the greatest concern. 

The CHAIRMAN. Thank you. 

Senator CORKER. 

Senator CORKER. It seems, also, that, in earlier testimony, that 

the disease claims—and you said so, just a minute ago—the claims 

of these particular products, and their ability to keep a disease 

from occurring or getting it—is the most serious claim that one 

might make on a label. Is that correct? 

Dr. SHARFSTEIN. Correct. 

Senator CORKER. I know the distinction is food not being 

preapproved, drugs being preapproved, and that’s part, I think, of 

the tension that Senator Hatch is trying to keep from happening, 

actually. Again, I’m a strong supporter of the dietary supplement 

120 

industry, from the standpoint of being a consumer and just seeing 

so many people use these types of products. But, in that particular 

area, is there a way to—with the retailers, for instance—is there 

not some shelf notification or something that the FDA could do to 

say that, if a product of X claims Y, it just, should not be sold? Is 

there a way for the retailers to actually check against that without 

a preapproval process actually having to occur? 

Dr. SHARFSTEIN. Well, I think that’s a great idea. I think we 

would be happy to hear from retailers that are concerned about 

products that are being, you know, peddled to them, that they’re 

concerned about a particular product, and we would then be able 

to look at it. 

But, we do take all these disease claims very seriously, and we 

would pursue enforcement action, if we could. It’s relatively easy 

for us to do, because it’s just the claim, alone, that makes that illegal. So, we see that someone’s trying to market something for cancer, and, boom, you know, you’re not allowed to do that. 

So, you know, I think we—FDA should be doing outreach, and 

working with the industry and the companies that are selling these 

products, to get the word out that, if they have concerns like that 

about products, that we would immediately take a look at them. 

Senator CORKER. But, are there not guidelines that you guys 

have published, where any retailer that’s serious would know that 

some claim by an entity that’s producing a particular product that 

has the ingredients that it says it has in it, there’s no way that 

that claim could be valid? Is there not some commonsense test that 

retailers would know a product that claims that absolutely could 

not be valid? 

Dr. SHARFSTEIN. You know, I’m not—I think we do work with retailers, and we would give them that guidance. I think it’s a very 

good idea, that they should—people—you know, the—generally— 

typically, we don’t think of the retailer as, like, a place to catch 

problems. 

But, in this case, and particularly where there are some major 

retailers, working with them would give us an opportunity to catch 

products. 

The—one of the challenges is the Internet, because, even though 

there are some major retailers, you know, anyone can set up a Web 

site and sell something. So, it gets a—it would get us, I think—if 

we had an effective relationship with the big retailers, we would 

be able to protect those areas from claims, perhaps, but we’d still 

be dealing with, probably, some problems through the Internet and 

other mechanisms. 

Senator CORKER. The good manufacturing practices that we referred to earlier, that, have not yet been implemented—and I’m 

going to leave and go to another meeting, and I thank you for your 

testimony and certainly the early witnesses. I know, you know, 

Senator Hatch certainly has talked about the funding that has 

lacked at the FDA, but is that the only issue that has kept y’all, 

for 16 years, from implementing some of the things that originally 

were put in place in 1994? Is it simply funding, or is it will? What 

is it that has kept you from implementing much of that law? 

Dr. SHARFSTEIN. Well, I think that—and I think you heard Mr. 

Mister talk about the fact that we are committed to implementing 

121 

DSHEA, and we have made progress. We have, now, those GMPs 

in place for the small—the large and medium firms, and, very 

shortly, for the small firms. We are committed to getting the guidance, which is very important, on the new dietary ingredients out. 

You know, I’ve been at the agency for a year, so I can’t speak 

to, you know, what happened before, but a lot of these, you know, 

things are—can be quite complicated and take much more time 

than you wish that they were going to take. I can—I’ve learned 

that already. 

But, I think, in general, I can say that we do think it’s important 

for FDA to do what it can under the law to really manage the risk 

side of the access/risk balance that I think DSHEA strikes. 

Senator CORKER. So, we had people in, earlier, on both sides of 

the issue—that some have concerns about the industry, people from 

the industry here feeling like they are doing what’s necessary to 

self-police. Senator Hatch has introduced legislation. That’s obviously one of the reasons we’re having this hearing today. Do you 

think that what he has addressed in his legislation seeks the balance that’s appropriate for this industry and, if implemented, and 

certainly funded, would do those things, as responsible department 

head, you would think would be appropriate? 

Dr. SHARFSTEIN. I think it—that that legislation—all the provisions of it make sense to FDA. There’s also language in the Food 

Safety bill that we think would be helpful, as you heard, I think, 

also, from different people in the last panel, including Mr. Mister. 

I think that the one—you know, one particular area where we— 

I have met, multiple times, with industry, because I know they’re 

very concerned about—relates to this issue of pharmaceutical spiking. I think that’s an area that really requires the industry, the 

agency, and others to think through the kind of science, law, resources, other things we can do to really make a lot more progress 

on that. I think, even though we have taken a lot of enforcement 

there, we feel like we need to do better. 

Senator CORKER. Does his legislation deal appropriately with 

pharmaceutical spiking? 

Dr. SHARFSTEIN. I think that there are gaps in what—in our understanding of what we can do to make a difference. So, I think it 

does what it can. I think it’s a good provision to have us, you know, 

kind of insist on FDA to be working with DEA. I think that makes 

sense. But, it’s very challenging, because, particularly for certain 

types of claims, we can’t—like I was saying before, if there’s a 

claim someone says cures cancer, than, boom, it’s illegal. 

The problem with have with pharmaceutical spiking is that the 

claims are not illegal. The claim will be muscle bulking or sexual 

enhancement or weight loss, which are permit—can be permitted 

claims. So, in order for us to get to the point of enforcement, we 

often have to do very sophisticated lab analysis, and that can be 

very time consuming and challenging. 

One project I saw at FDA, they found 37 varieties of Viagra. You 

know, basically they took pharmaceutical Viagra and they—somebody changed little bits of it, as a chemical entity, and put it in, 

to evade detection. It took, you know, Ph.D. chemists quite a long 

time to unpack that. 

122 

To do that kind of testing on so many different products is extremely challenging. That’s what makes it—there was a—FDA testified at a hearing last fall about this, and really went into tremendous detail about the challenge facing the agency here. I don’t 

think that we’ve really solved that challenge. I’m not sure that we 

had—have the answer to that, but I do think, in this area, that’s 

probably our biggest concern right now. 

Senator CORKER. Mr. Chairman, thank you. 

Thank you for your testimony and for your service. 

Thank you. 

The CHAIRMAN. Thank you for being here, Senator Corker, and 

thank you for contributing as much as you have to this hearing. 

Senator HATCH. Senator HATCH. Thank you, Mr. Chairman. 

Mr. Sharfstein—no, Dr. Sharfstein, first, I want to thank you for 

your testimony here today, and for acknowledging that DSHEA 

strikes the right balance. Every FDA commissioner since DSHEA 

has told me that they have enough authority under DSHEA to resolve the conflicts in this industry. We’ve tried, in addition, to pass 

additional statutes that will give you even more authority and 

would help you. 

So, there’s a desire here to do what’s right. Please know that I 

agree with you that enforcement of DSHEA is our top priority; I 

mean, when it comes to dietary supplements. So, I’m grateful for 

much of your testimony here today. 

Now, Dr. Sharfstein, the FDA has recently received more funds, 

and appears to be taking more—a great deal more action. Would 

you agree with that statement? 

Dr. SHARFSTEIN. Yes. I would agree with that. 

Senator HATCH. OK. Now, that being said, is it fair to say that 

the FDA does need additional funding before we implement and enforce the current laws with—which regulate dietary supplements? 

Dr. SHARFSTEIN. Well, I think we’re on track to fully implement 

and enforce. We’re going to be putting all the GMPs in place and 

we—we are on track for the new dietary guidance to—‘‘new dietary 

ingredient’’ guidance to come out, albeit a lot later than a lot of us 

would want. 

Senator HATCH. But, you still could use more money, because of 

the monumental number of companies and number of products in 

this industry. 

Dr. SHARFSTEIN. Well, we’re anticipating doing about 250 GMP 

inspections in fiscal year 2010. We think there are about 1500, 

roughly, companies out there. So, you know, it’s a pretty good fraction to do, as we’re learning about it. I mean, I think it’s obvious, 

with more resources, we would do more, but I think we’re on—we 

feel like we’re on a pretty good track. It’s been frustrating to you, 

members of the industry, us, and others, that these pieces haven’t 

been in place. But, I think we are beginning to see those pieces fall 

into place. 

Senator HATCH. Well, I’m happy to hear that. I’m looking at the 

FDA’s Total Diet Study statistics on element results for various 

food products, and in this report I see that a number of milk and 

cheese products contain arsenic, cadmium, lead, and other heavy 

metals. 

123 

I also have a study here that are—that was published in the 

Journal of Dairy Science. The study is titled, ‘‘A Survey of Selected 

Heavy Metal Concentrations in Wisconsin Dairy Feeds.’’ I’m trying 

to help my colleague from Wisconsin to—you know, to—we’ve got 

to work together on these matters. It surveys the heavy metal content of 203 typical dairy feed products from 54 dairy farms in Wisconsin. It found that there were various levels of heavy metals 

throughout the dairy food chain. Now, am I saying that—that this 

poses some sort of a—or a kind of health concern? 

Dr. SHARFSTEIN. Well, I’ll tell you how I think about these levels 

of various heavy metals. There’s sort of two categories that I put 

it in. 

One category is the—you know, what most people would characterize as very low levels, and we want to keep them as low as possible—— 

Senator HATCH. Right. 

Dr. SHARFSTEIN [continuing]. Just to reduce over—you know, 

overall levels. That’s pretty much how I would characterize the 

findings of the GAO report. 

Senator HATCH. Right. 

Dr. SHARFSTEIN. Right—in that category. I think, in food, it’s a 

similar type of thing. There are low levels of things, and we want 

to, generally, figure out how to keep them low, and lower, if possible. 

The other category are levels that actually pose a real threat to 

health, and that was—there was recently a recall of a dietary supplement, for 1100 parts per million of lead, which is more—almost 

twice the legal limit for lead in paint. That’s not a safe amount, 

and we really had to take action there. 

I do think that, you know, it’s important to distinguish those. I 

consider that a little bit of a warning that it’s very important. I 

know that the industry is very serious about this, to—that the companies understand their supply chain, and really make sure the ingredients they’re using are not contaminated with lead. 

Senator HATCH. Well, that report does confirm that Wisconsin 

dairy products are safe. I, personally, would put that State’s dairy 

products at the top of the list, right under Utah’s dairy products, 

of course. 

But—so, let me ask your—you this. Hasn’t the FDA already established safe levels of heavy metals and trace elements in our food 

products? Don’t those standards already allow the FDA to determine safe levels for dietary supplements? 

Dr. SHARFSTEIN. I’d have to get back to you with a complete answer on that. 

Senator HATCH. OK. 

Dr. SHARFSTEIN. I mean, I think our testimony here is that the 

levels that GAO found in the supplements are not of significant 

health concern. I do think that that one recent recall was, though. 

Senator HATCH. OK. Let me just ask one more question. In 1994, 

DSHEA set forth the definition of a ‘‘new dietary ingredient.’’ I 

know the FDA has been working on a ‘‘new dietary ingredient,’’ or 

NDI, guidance document to better clarify when a dietary supplement is considered a ‘‘new dietary ingredient.’’ The evidence needed 

to document the safety of new dietary ingredients, and the approVerDate Nov 24 2008 15:05 Oct 19, 2010 Jkt 000000 PO 00000 Frm 00127 Fmt 6633 Sfmt 6633 H:\DOCS\57983.TXT SAG PsN: JOYCE
124 

priate methods for establishing the identity of a new dietary ingredient, they’re working on. 

In addition, in a January 2009 GAO report entitled, ‘‘Dietary 

Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding,’’ one of the GAO’s recommendations was that the FDA should promptly issue the NDI 

guidance. Now, could I ask why it’s taken so long for the FDA to 

issue guidance—you know, these particular guidance documents? 

What is the current status of the NDI guidance document? 

Dr. SHARFSTEIN. Sure. I think it’s taken so long, in part, because 

it’s a challenging topic to figure out how to define, how to help people think through both what qualifies as an NDI and what kind of 

information that we’d have. 

I tell people in this job, I’ve got, you know, two lists of things on 

my desk: one list of things that are—need to be moving much faster than they’re actually moving forward; and the other list of 

things that are moving at about the right speed. There’s nothing 

on the second list, you know. [Laughter.] 

So, you know, I think that everybody wants this guidance out. 

The industry wants it out, we want it out. I think that there—it’s 

challenging science, in part, and law. We’re anticipating having it 

out by the end of the calendar year. 

Senator HATCH. Well, as I—if I recall it correctly, it took since 

1994 to 2007 to get GMP recommendations. That’s one of the reasons why I think you do need some more money or you do need 

some help here. That’s really important, especially in an industry 

that takes a certain amount of criticism, even though by and large, 

most all the products are good products. But, I’m going to help you 

in every way I possibly can. 

Let me just close by saying that, since you left Henry Waxman, 

we haven’t been able to get together on anything. So, you’d better 

get back up here on Capitol Hill. We feel badly that you—— 

Dr. SHARFSTEIN. OK. 

Senator HATCH [continuing]. Betrayed us by leaving here and 

going to the FDA. But, we compliment you on being in your present 

position, and how important it is, in my eyes, and how important 

you really are to the people in America. I’ve really have appreciated your testimony here today. 

Dr. SHARFSTEIN. OK, thank you very much. 

The CHAIRMAN. Thank you very much, Senator Hatch. With respect to your budget, Senator Hatch indicated that we may have 

to take another look at your budget. He’s certainly right about that. 

But, I am pleased, as I’m sure you were, when the committee, of 

which I’m chairman, increased the budget for the FDA by $152 million last year, and much of that has gone into, I think, food safety 

examination and enforcement and oversight, hasn’t it? 

Dr. SHARFSTEIN. That’s absolutely true. I think the—those increases have really revitalized the food program, and it—you and 

the committee really deserve tremendous thanks, not only by the 

agency, but all the people who rely on the agency’s evaluation of 

food. 

The CHAIRMAN. No question, food safety in America is paramount. The results of your investigation into the information that 

125 

you got from the GAO recently, that will be made public when 

those results are finished—when that examination is finished? 

Dr. SHARFSTEIN. Sure. We’d be happy to write the committee and 

release those results. 

The CHAIRMAN. Thank you so much. 

Normally, how long does that take? Several weeks, or a month 

or two, or—— 

Dr. SHARFSTEIN. Well, it depends, in part, on the level of our engagement. If we decide that we’re going to pursue enforcement action against a company, that sometimes takes a while, because we 

work with the U.S. attorneys and, you know, there’s a whole enforcement process that has to play out. We can get results—we can 

get significant ill-gotten gains back for the—to people, we can—you 

know, there can be criminal prosecutions—but, those things can 

take time. 

So, we could, you know, probably give you an interim update at 

a certain point, but I don’t want to promise a particular timeframe, 

because sometimes the—you know, the really intense enforcement 

can take a little while. 

The CHAIRMAN. Certainly. 

Well, I’d like to compliment you, Dr. Sharfstein, as well as Dr. 

Hamburg. I think you’re doing a great job at the FDA. A very, very 

important part of America, in terms of ensuring the safety of the 

products that we eat and ingest. We owe you much appreciation for 

what you do, and we look forward to continuing our efforts with 

you and with your organization. 

Thank you all for being here today. 

We will now close our hearing. 

[Whereupon, at 4:08 p.m., the hearing was adjourned.] 

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A P P E N D I X 

PREPARED STATEMENT OF SENATOR AL FRANKEN

Thank you, Mr. Chairman, for holding today’s hearing on such an important topic 

for Minnesota seniors and all Americans. 

It’s important to understand that the issue of dietary supplements is fundamentally about enabling Americans to make informed choices about their health. For example, several years ago, researchers discovered that grapefruit interacts with cholesterol-lowering medications. It interferes with enzymes that metabolize these 

drugs in the digestive system. So if you eat grapefruit while you’re on a statin, you 

can end up with excessive levels of the drug in your blood, and an increased risk 

of serious side effects. 

Although this interaction is potentially harmful, it does not mean that we need 

to outlaw grapefruit! Rather, it means we can avoid problems by educating consumers and doctors. Research and education are crucial to ensuring dietary supplements are taken safely and effectively. This is especially true for older Americans, 

who take more supplements and more prescriptions than younger adults. 

I believe all Americans who want them—and especially seniors—should have access to safe dietary supplements. I’d like to thank our witnesses for being here today 

to share their expertise on this issue. I look forward to your testimony. 

MR. MISTER’S RESPONSE TO SENATOR FRANKEN’S QUESTION

Question. Mr. Mister, I’m a big fan of Medication Therapy Management, a service 

in which pharmacists sit down with seniors and other patients with chronic illness 

to make sure multiple prescriptions are taken properly and safely. Today we’ve 

heard about the risks of potential interactions between dietary supplements and 

prescription drugs. What role can pharmacists and medication therapy management 

play to educate consumers about the potential interactions of dietary supplements? 

Answer. Pharmacists play an instrumental, important and trusted role in providing information to their consumers utilizing multiple prescriptions. Medication 

therapy management (MTM) is another useful tool pharmacists can use to educate 

elderly consumers about the potential interactions that may occur with their medications and other products they may be ingesting. Pharmacists, in particular, are 

in an ideal position to provide key information about drug/nutrient interaction and 

drug/nutrient deficiency health advice, as well as be an information resource for senior citizens on the benefits of many health related products. Conversely, it is equally 

important that pharmacists provide information in context and not unnecessarily 

alarm senior citizens. To benefit their consumer, the pharmacists should not only 

focus on pill interactions, but be aware of potential issues caused by foods in the 

diet, too. 

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