February 28, 2008


The Honorable Andrew C. von Eschenbach, M.D.
Commissioner 
United States Food and Drug Administration
Parklawn Building/Mail Code: HF-1
5600 Fishers Lane
Rockville, MD 20856

Division of Dockets Management
(HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dear Commissioner von Eschenbach:

Re:  Draft Guidance for Industry (Docket No. 2007D-0491) entitled: Questions and 
Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary 
supplement and Nonprescription Drug Consumer Act (73 Fed. Reg. 196, January 2, 
2008), and Draft Guidance for Industry (Docket No. 2007D-0496) entitled: Questions 
and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (73 Fed. Reg. 197, 
January 2, 2008). 

Congress established the Office of Advocacy (Advocacy) under Pub. L. 94-305 to 
represent the views of small business before Federal agencies and Congress.  Advocacy is 
an independent office within the U.S. Small Business Administration (SBA); as such the 
views expressed by Advocacy do not necessarily reflect the views of the SBA, or of the 
Administration.  Section 612 of the Regulatory Flexibility Act (RFA) also requires 
Advocacy to monitor agency compliance with the RFA, as amended by the Small 
Business Regulatory Enforcement Fairness Act.(1)

As Chief Counsel for Advocacy, I am writing because my office has received inquiries 
from small dietary supplement manufacturers and their representatives (including the 
American Herbal Products Association) voicing concern with the Food and Drug 
Administrations (FDA) Draft Guidance for Industry: Questions and Answers Regarding 
the Labeling of Dietary Supplements as Required by the Dietary supplement and 
Nonprescription Drug Consumer Act (73 Fed. Reg. 196, January 2, 2008), and Draft 
Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary 
Supplements as Required by the Dietary Supplement and Nonprescription Drug 
Consumer Protection Act (73 Fed. Reg. 197, January 2, 2008).(2)  Industry 
representatives have told Advocacy that they are concerned that the draft guidance will 
have a significant economic impact on their industry.  Therefore, I want to take this 
opportunity to comment on the draft guidance and alert the FDA about many of the 
concerns those industry representatives have voiced to Advocacy. 

Legislative and Regulatory Background

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (Act) was 
signed into law on December 22, 2006, and went into effect on December 22, 2007.  The 
Act required the FDA to publish guidance on the minimum data elements that should be 
included in a serious adverse event report as described by the amendments in the Act.  
The FDA published the prescribed guidance in the Federal Register on October 15, 2007, 
when it announced the availability of two separate draft guidance documents: one for 
dietary supplements (72 Fed. Reg. 58313); the other for nonprescription drug products 
(72 Fed. Reg. 58316).  

On January 2, 2008, the FDA published two additional draft guidance documents that 
provided questions and answers regarding the labeling of dietary supplements (73 Fed. 
Reg. 197), and for the labeling of nonprescription products (73 fed. Reg. 196).  The FDA 
asserts that the draft guidance documents represent its recommendations and 
requirements under the Act. 

Considering the likely effect of the draft guidance, the FDA should consider making 
the guidance a rulemaking subject to notice and comment.

Industry representatives suggested that the true effect of the draft guidance will force 
businesses to comply with its provisions which will have a significant economic impact 
on an industry that is comprised of predominately small businesses.  The industry 
justifies this assessment based on the fact that no dietary supplement labels currently 
carry information to inform consumers that the address or phone number on the dietary 
supplement label is for reporting serious adverse events.  The industry assumes that the 
draft guidance will require that all dietary supplements will need to be relabeled in order 
to meet the FDAs recommendations and requirements.   

Industry representatives argue therefore, that the draft guidance should be a rulemaking 
pursuant to the Administrative Procedure Act (APA)(3) rather than a mere guidance 
document.  The APA requires agencies to publish rules for public notice and comment.    
The RFA requires that during rulemaking, the promulgating agency must analyze the 
rules economic impact on small businesses and analyze regulatory alternatives that 
minimize the regulations impact on those businesses; unless it can certify that the 
rulemaking will not have a significant impact on a substantial number of small 
businesses.(4)

Affected small businesses point out that in a prior rulemaking in 2003 the FDA estimated 
that there were 29,514 dietary supplement stock-keeping units (SKUs).(5)  In the same 
rulemaking FDA estimated that the cost of re-labeling (exclusive of inventory disposal) 
would be between $2,400 and $4,200 per SKU.  Therefore, the cost of re-labeling dietary 
supplements under the draft guidance would be between $70 million and $124 million (in 
2003 dollars).  Industry suggests that the aforementioned estimates may indeed be too 
low based on data from the Office of Dietary Supplements at the National Institutes of 
Health (NIH) which places the number of dietary supplements sold in the United States at 
between 50,000 and 60,000.  Utilizing NIHs estimates the cost of re-labeling dietary 
supplements under the guidance would be between $120 million and $252 million. 

Most importantly, the FDAs own Good Guidance Practices suggest that guidance 
documents should not convey the agencys interpretation of, or policy on, a regulatory 
issue as they are not considered binding.(6)  Industry representatives disagree with the 
FDAs interpretation of section 3 of the Act. Those representatives argue that the 
legislative intent of section 3 of the Act does not mandate that the product label contain 
a full U.S. mailing address as the draft guidance suggests.  

This is an important distinction because the Office of Management and Budgets (OMB) 
final bulletin on Agency Good Guidance Practices (GGP), which establishes policies and 
procedures for the development, issuance, and use of significant guidance documents by 
Executive Branch Departments and agencies, indicates that given their legally 
nonbinding nature, significant guidance documents should not include mandatory 
language, unless the agency is using the words to describe a statutory requirement.(7) 
?(8)(9)  Moreover, if you accept FDAs and NIHs estimates as to the costs associated 
with re-labeling dietary supplements to bring them into compliance with the requirements 
of the Act, FDA would have to seek OMB review of the draft guidance as the costs 
exceed $100 million.

While the draft guidance is meant to inform the regulated dietary supplement industry of 
the FDAs interpretation of the enforcement aspects of the Act, the guidance clearly 
mandates that product labels must bear a full U.S. mailing address that includes the 
street address or P.O. Box, and the city, state, and zip code of the responsible party, if a 
phone number is not provided.  The mandatory nature of this provision suggests that the 
draft guidance should be considered a rulemaking.           

Based on the recommendations from small dietary supplement manufacturers, Advocacy 
recommends that the FDA consider subjecting the provisions contained in the draft 
guidance to notice and comment rulemaking.

The FDA may have exceeded the legislative intent of The Dietary Supplement and 
Nonprescription Drug and Consumer Protection Act, and the draft guidance is 
inconsistent with existing Federal rules.

Small dietary supplement manufacturers acknowledge that dietary supplement labels are 
now required to carry a domestic address or domestic phone number through which a 
responsible person may receive a report of a serious adverse event under section 3 of the
Act.  Those small businesses take exception with the FDAs draft guidance which 
incorporates the Acts legislative mandate by stating that, the statute requires that the 
product label bear a full U.S. mailing address that includes the street address or P.O. Box, 
and the city, state and zip code of the responsible person.  

Dietary supplement representatives argue that existing labeling regulations require 
dietary supplement labels to disclose a place of business, a requirement that can be met 
without a street address, if it is shown in a current city directory of telephone 
numbers.(10)  Small dietary supplement manufacturers submit that Congress did not 
contemplate such a substantive change in the labeling requirements currently required 
under Federal regulation; otherwise Congress would have use more specific language in 
the Act.  More importantly, industry suggests that the guidances requirement for address 
labeling should be consistent with the existing labeling requirements for food and drugs 
so long as any interested person can locate the business to report a serious adverse event.  

By requiring that the label bear a full mailing address, the small dietary manufacturers 
will incur considerable new labeling costs.  Subjecting the guidance to rulemaking would 
require the FDA to entertain alternatives (e.g., not requiring a full mailing address) that 
would minimize the costs on affected industry. 

FDAs recommendation that the dietary label bear a prominent statement 
informing consumers that the domestic address or phone number is for reporting 
serious adverse events associated with the use of the product is not required by the 
Act and will cause manufacturers to incur significant re-labeling costs.

Small dietary supplement manufacturers point out the FDA acknowledges in the draft 
guidance that the Act does not require the label to include anything other than a domestic 
address or domestic phone number.  Industry representatives are concerned that FDAs 
recommendation that the additional language be placed on the label will ultimately 
have the effect of establishing a requirement through guidance that will greatly increase 
costs to the industry.  Further, the FDAs recommendation contradicts the legislative 
intent as expressed in the September 5, 2006, Report of the Senate Committee on Health, 
Education, Labor and Pensions, which stated that, the legislation does not require the 
label to make any statement other than providing the address or phone number.(11)

Advocacy suggests that the FDA reconsider including this recommendation for labeling 
in the guidance because it has the potential to greatly increase costs to industry.  Further, 
if the guidance was subject to rulemaking the FDA would have a chance to analyze the 
impact that such a recommendation would have on industry and an opportunity to design 
less burdensome alternatives. 

Industry representatives argue that the draft guidance will effectively shorten the 
time small dietary manufacturers would usually have to make label changes under 
existing FDA regulation.

The FDAs Guidance for Industry Questions and Answers publication indicates that the 
labeling requirements of section 502(x) of the Act became effective on December 22, 
2007; one year after the Act became effective.(12)  The draft guidance further states, We 
believe that it is reasonable to allow an additional one-year period for firms whose labels 
do not yet meet the requirements of section 502(x) of the Act to bring their labeling into 
full compliance.(13)  The FDA states that it will begin enforcing the labeling 
requirements of section 502(x) of the Act on or after January 1, 2009.(14) 

Small dietary supplement manufacturers suggest that their options, e.g., the ability to sell 
existing inventories, have been severely hampered by such a short enforcement delay. 
The effect of the short enforcement delay will be to significantly impact the industry.  
They argue that had FDA endeavored to regulate these labeling guidance requirements 
through rulemaking, the industry would have had more time to make the necessary 
labeling changes.  Industry points out that the draft guidance is inconsistent with FDAs 
January 1, 2010, uniform compliance date for food labeling issued between January 1, 
2007, and December 31, 2008.(15)   Per the FDA, the uniform compliance date 
regulation provides for, an orderly and economical industry adjustment to new labeling 
requirements by allowing sufficient lead time for industry to plan for the use of existing 
label inventories and the development of new labeling materials.(16)  

By establishing the new labeling requirements through the use of guidance, the FDA has 
effectively limited the time industry has to comply with its requirements in an 
economical fashion.  The FDA should revisit its position on enforcement on this matter 
and consider the potential benefits of subjecting the draft guidance to rulemaking.

Conclusion

In summary, Advocacy requests that the FDA give consideration to the issues raised in 
this comment letter.  Advocacy encourages FDA to better analyze the possible effects of 
this regulation on the dietary supplement industry which is predominately comprised of 
small businesses. 
Thank you for your attention to the above matter.  If you have any questions or concerns, 
please do not hesitate to contact me or Assistant Chief Counsel, Linwood Rayford at 
(202) 401-6880, or linwood.rayford@sba.gov.


Sincerely,

/s/

Thomas M. Sullivan
Chief Counsel Advocacy

/s/

Linwood L. Rayford, III
Assistant Chief Counsel for Food, Drug
And Health Affairs


cc: The Honorable Susan Dudley, Administrator, Office of Information and Regulatory 
Affairs, OMB


ENDNOTES

1.  Pub. L. No. 96-354, 94 Stat. 1164 (1981) (codified at 5 U.S.C.  601-612) amended 
by Subtitle II of the Contract with America Advancement Act, Pub. L. No. 104-121, 110 
Stat.857 (1996). 5 U.S.C. 612(a).
2. Hereafter, both guidance documents will be referred to jointly as the draft guidance. 
3. 5 USC section 553.
4. Id. at section 603. 
5.  See FDA rulemaking: Food Labeling: Ingredient Labeling of Dietary Supplements 
that Contain Botanicals (68 Fed. Reg. 51738, August 28, 2003).  
6.  See: www.fda.gov/cder/audiences/iact/forum/200704_derr.pdf. 
7.  72 Fed. Reg. 3432, January 25, 2007. 
8.  Advocacy suggests that FDAs draft guidance is significant as defined in the OMB 
bulletin which states, guidance documents are considered significant when they have a 
broad and substantial impact on regulated entities, the public, or other Federal agencies.  
Id. at 3435. 
9.  OMBs  GGP was incorporated into Executive Order (EO) 13422 which amended EO 
12866.   
10. 21 CFR 101.5(d) for food and 21 CFR 201.5(i) for drugs. 
11. Calendar No. 586; 109th Congress, 2d Session; Senate Report 109-324, at page 9.
12. Guidance for Industry: Questions and Answers Regarding the Labeling of 
Nonprescription Human Drug Products Marketed Without an Approved Application as 
Required by the Dietary Supplement and Nonprescription Drug Consumer Protection 
Act, December 2007, page 6.
13. Guidance for Industry, supra.
14. Guidance for Industry, supra.
15. 71 Fed. Reg. 76599, December 21, 2006.
16. Id.