Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/07/page/2/
Timestamp: 2016-10-22 06:59:37
Document Index: 354461256

Matched Legal Cases: ['arts 710', '§ 601', 'art 700', '§ 601', '§ 4205', '§ 156', '§ 156', '§ 156', '§ 156', '§ 505', '§ 740', '§ 741']

FDA Sued Over Enforcement Action on Marketed Unapproved Morphine Sulfate Oral Solution By Kurt R. Karst – Earlier this week, Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the U.S. District Court for the District of Wyoming requesting that the court enjoin FDA from taking any enforcement action with respect to their marketed unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL products. The lawsuit is (to our knowledge) the first challenge arising from FDA’s Unapproved Drugs Initiative, which was kicked off in June 2006 with the publication of the Agency’s Compliance Policy Guide (“CPG”). FDA’s CPG articulates the Agency’s risk-based enforcement approach to taking enforcement action with respect to the manufacture and distribution of marketed unapproved drugs. Under that policy, FDA gives higher priority to enforcement action against unapproved drugs in certain categories, including drugs that present direct challenges to the “new drug” approval and over-the-counter drug monograph systems (e.g., when a drug is approved under an NDA and other companies market the same product without approval). (An article we authored that appeared in RAPS Focus a couple of years ago discussing the world of marketed unapproved drugs is available here.)
Shortly thereafter, in April 2009, FDA announced that the Agency would reverse course to allow the continued marketing and distribution of one of the drug products – Morphine Sulfate Solution Immediate-Release 20mg/mL – on an interim basis due to concerns over a drug shortage, and sent letters to the affected parties, including Cody and Lannett. (see our previous post here) Specifically, FDA stated that the Agency would exercise discretion not to take enforcement action “until 180 days after any firm receives approval for a morphine sulfate oral solution 20 mg/ml product.” FDA approved an NDA for Morphine Sulfate Solution Immediate-Release 20mg/mL on January 25, 2010. In follow-up letters sent to Cody and Lannett (here and here) in March 2010, FDA stated that consistent with the Agency’s previous communications, FDA would exercise enforcement discretion with regard to the shipment and distribution of Cody’s/Lannett’s unapproved Morphine Sulfate Solution Immediate-Release 20mg/mL until July 24, 2010. Meanwhile, Lannett submitted its own NDA to FDA in late February 2010. Cody/Lannett have continued to market their unapproved morphine sulfate products, but have reportedly encountered problems in obtaining quota from the Drug Enforcement Administration for additional raw material to manufacture new product – apparently as a result of FDA’s position on this unapproved drug.
The 1938 and 1962 grandfather clauses in the FDC Act have been construed very narrowly by FDA and the courts. FDA believes that there are few, if any, marketed drugs that are actually entitled to grandfather status, because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage form, strength, method of manufacture, route of administration, indications or intended patient population. If a company claims that its product is grandfathered, FDA considers it the firm’s burden to prove that assertion. FDA stated in the Agency’s 2006 CPG that it believes “it is not likely that any currently marketed prescription drug product is grandfathered or is otherwise not a new drug,” but recognizes that “it is at least theoretically possible” that such a product exists. Cody/Lannett take aim at FDA’s 2006 CPG in their lawsuit, stating that the CPG “operated effectively to render the grandfather provisions of the FDCA inoperative,” and that the CPG “is contrary to the express terms of the statutory grandfather provisions of the FDCA, through which Congress expressed an unequivocal intent that the FDCA apply only prospectively to ‘new drugs’ and not retroactively to drugs on the market at the time of its passage.”
Cody/Lannett also allege that FDA violated the APA by not treating Cody/Lannett fairly in the NDA process. Specifically, that FDA provided another company “greater assistance in moving through the NDA process” and by creating “substantial delays in scheduling meetings with Cody/Lannett and denying Cody/Lannett’s request for expedited treatment of its NDA.” Posted at 01:11 PM in Drug Development | Permalink
Misrepresentation of Active Ingredients Can Be Actionable Under the Lanham Act
By Nisha P. Shah – A U.S. District Court recently held that misrepresentation and false description of active ingredients by a manufacturer of generic prescription vitamins can be actionable under the Lanham Act. Sciele Pharma, Inc. v. Brookstone Pharmaceuticals, LLC. Plaintiff, Sciele Pharma, Inc., develops and sells branded prescription products, including the prenatal vitamins PRENATE ELETE and PRENATE DHA. An alleged unique feature of PRENATE is that it contains a 1 mg combination of 400 mcg of folic acid and 600 mcg of L-Methylfolate (“L-MTHF”), a bioactive form of folate that does not require additional metabolism by the body. Defendant, Brookstone Pharmaceuticals, LLC, a/k/a Acella Pharmaceuticals, LLC, develops and sells generic prescription prenatal vitamins called PNV and PNV-DHA. Defendant’s labels and package inserts represent that PNV vitamins contains the same combination of folate as the PRENATE vitamins. However, plaintiff asserts in this litigation that defendant’s vitamins do not contain L-MTHF, but rather a different dietary ingredient known as D,L-MTHF. This ingredient allegedly contains an equal mixture of the L-isomer and D-isomer of MTHF. According to plaintiff, D,L-MTHF and L-MTHF are recognized as distinct dietary ingredients. Plaintiff also claims that the presence of the D-isomer may be harmful to women taking the PNV vitamins. Plaintiff argues that defendant’s labels and package inserts for PNV vitamins are false and likely to deceive consumers, pharmacists, and others in the pharmaceutical distribution chain as to the content of the vitamins. Since PNV vitamins are cheaper than PRENATE vitamins, plaintiff contends that pharmacists could decide to substitute PNV for PRENATE, despite having different active ingredients. Plaintiff asserts claims under (1) the Lanham Act for false advertising and unfair competition, and (2) the Georgia Uniform Deceptive Practices Act. Defendant filed a motion to dismiss on the grounds that the Federal Food, Drug, and Cosmetic Act (“FDCA”) precludes plaintiff from bringing Lanham Act claims. The Court initially recognizes that the FDCA does not allow for a private right of action and that a tension exists between the FDCA and the Lanham Act in cases involving products regulated by FDA. Further, the Court remarks that plaintiffs cannot use the Lanham Act as a vehicle to enforce the FDCA. Nevertheless, the Court looks at “the extent to which the plaintiff relies on the FDCA as the basis for its claim, or alternatively the extent to which the claim would require the Court to interpret or apply the FDCA or FDA regulations.” Id. at *10. According to the Court, “plaintiff credibly argues” its claim that defendant is misrepresenting the content of the PNV vitamins “can, and will, be proven without reference to the FCDA.” Id. at *12. In rejecting defendant’s motion, the Court concludes that “the simple fact that a Lanham Act claim touches upon an area that is within the purview of the FDCA is not a bar to proceeding,” and that “the Lanham Act prohibits exactly the type of misconduct that plaintiff alleges in its complaint: the misrepresentation and false description of the nature of the product.” Id. at *12-13.
The Court similarly dismisses Brookstone’s second motion to dismiss on the merits of the Lanham Act claims. Defendant argues that plaintiff’s claims cannot success because defendant complied with Georgia law on pharmaceutical substitution and that the disclaimers used with the vitamins insulate defendant from Lanham Act liability. According to the Court, at the motion to dismiss stage, it must accept as true plaintiff’s allegations that the L-MTHF in PRENATE vitamins and the D,L-MTHF in the PNV vitamins are distinct dietary ingredients, and therefore, the two vitamins are not legally substitutable. If plaintiff’s claims are accurate, the Court concludes that defendant’s misrepresentation is “unquestionably actionable under the Lanham Act.” Id. at *14-15. Moreover, the Court agrees with plaintiff’s argument that the disclaimer issue is better resolved on a motion for summary judgment or at trial. The Court also addresses several other motions, including the Court’s grant of plaintiff’s motion to remove the confidentiality designation to documents that (1) identify defendant’s manufacturers and suppliers, and (2) state the current formulation and/or ingredients of PNV vitamins, as both types of documents are not considered trade secrets. ADDITIONAL READING:
March/April 2010 issue of FDLI Update article - The Lanham Act: Another Vehicle to Enforce the FDC Act?
Posted at 01:11 PM in Drug Development | Permalink
By Kurt R. Karst – Earlier this week, Rep. Jan Schakowsky (D-IL), along with Reps. Ed Markey (D-MA) and Tammy Baldwin (D-WI), introduced H.R. 5786, the Safe Cosmetics Act of 2010. The bill would significantly change the regulatory structure of cosmetics in the U.S., more closely aligning it with other FDA-regulated products, such as drugs, biologics, and medical devices. Except for color additives, there is no requirement today that a cosmetic establishment be registered with FDA or that a cosmetic ingredient be approved by, or even listed with, FDA prior to use. Instead, FDA administers voluntary cosmetic establishment registration and ingredient filing programs (21 C.F.R. Parts 710 & 720). Currently, FDC Act § 601(a) simply establishes a general principle that a cosmetic shall be deemed to be “adulterated” (and thus subject to regulatory action by FDA) “[i]f it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual. . . .” FDA’s regulations prohibit or restrict the use of certain ingredients in cosmetics. Most of these regulations appear in 21 C.F.R. part 700. FDA would consider a cosmetic containing an ingredient in violation of any of the prohibitory regulations to be adulterated. FDA may initiate regulatory action (including, for example, a civil seizure action in a U.S. district court, or a request for recall) whenever the Agency concludes that a particular ingredient used in a cosmetic product violates the general adulteration standard of FDC Act § 601(a).
Require domestic and foreign establishments that manufacture, package, or distribute cosmetics to register annually with FDA, including providing FDA with contact information, a description of the establishment’s activities, gross receipts, the number of employees, and the name and address of any company that supplies a cosmetic manufacturing establishment with ingredients for its products. FDA would be required to make its registration list publicly available, but not the registration documents. Establishments would also be required to provide detailed product-specific information to FDA; Require FDA to establish a “schedule of fees . . . to provide for oversight and enforcement” of the new FDC Act subchapter on the regulation of cosmetics. Such fees would be prorated based on an establishment’s gross receipts or sales, and would only be assessed on companies with annual gross receipts or sales of more than $1 million; Require, within one year after the date of enactment of the Safe Cosmetics Act of 2010, “the label on each package of cosmetics, including cosmetics distributed for retail sale and professional use, to bear a declaration of the name of each ingredient in such cosmetic in descending order of predominance.” A similar requirement applies to Internet vendors with respect to providing ingredient information; Require manufacturers and distributors of cosmetics and ingredients to submit (in an electronic format) to FDA, not later than one year after the date of enactment of the Safe Cosmetics Act of 2010, “all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to [FDA] regarding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels,” including function and uses, tests of cosmetics, and exposure and fate information; Require FDA to issue regulations not later than two years after the date of enactment of the Safe Cosmetics Act of 2010 that includes lists of ingredients identified by the Agency as “prohibited ingredients,” “restricted ingredients,” or “safe without limits” for use in cosmetics. FDA must also develop a “priority assessment list of not less than 300 ingredients” that cannot be included on the above-referenced lists “because of a lack of authoritative information on the safety of the ingredient.” FDA must make safety determinations for these ingredients. Prohibit companies from manufacturing, importing, distributing, or marketing a cosmetic or cosmetic ingredient if the company failed to provide information to FDA as required under the bill or if the company’s products contain non-permitted ingredients; Require responsible parties to notify FDA if a marketed cosmetic “is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health consequences or death to humans.” FDA may request a voluntary recall of the affected products, issue an order for the company to cease distribution, and, under certain circumstances, require a recall or issue an emergency recall order; Give FDA the authority to require that cosmetics containing “nano-scale” materials be labeled as such; Mandate the reporting of adverse health effects associated with the use of a cosmetic; and
Require FDA to publish a list of “alternative testing methods” that do not involve the use of animals to test a chemical substance and that must be used in product testing where practicable. (As we recently reported (here and here), FDA was sued by a coalition of animal rights advocates for not substantively responding to a November 2007 citizen petition requesting that Agency require drug and device companies to submit data only from non-animal test methods whenever available. FDA subsequently denied the citizen petiton and explained that there are currently no suitable non-animal alternatives to the testing necessary for FDA to conclude that a drug or device is safe for human use.) The introduction of H.R. 5786 comes just days after The Personal Care Products Council (“PCPC”) (formerly CTFA) announced that the organization had sent a letter to key health policy leaders in Congress outlining “a number of new science-based regulatory changes that we believe should be adopted in legislation that would further strengthen the effective FDA regulation of our products – including FDA reviews of cosmetic ingredients.” The PCPC proposal includes enhanced FDA registration, a new process to set safety levels for trace constituents, a new FDA ingredient review process, new FDA oversight of Cosmetic Ingredient Review findings, and FDA-issued Good Manufacturing Practices. Several of these proposal are included in H.R. 5786 in one form or another.
Posted at 11:08 AM in Cosmetics | Permalink
FDA Seeking Public Comment on Federal Menu Labeling Requirements By Susan J. Matthees – FDA recently announced that the Agency is seeking public comments on how to implement section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose nutrition information. The docket opened on July 7 and will remain open for comment for 60 days. Under PPACA § 4205, chain restaurants and retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu (“chain restaurants”) as well as vending machine owners or operators with 20 or more vending machines must display certain nutrition information. The law does not limit the location count to the United States, so it is not clear whether restaurants and vending machines outside the US count towards the 20 limit. Chain restaurants with drive-through menus must display calorie information next to each standard menu item. All chain restaurants also must include on menus the Secretary of the Department of Health and Human Services’ (“the Secretary”) statement on suggested daily caloric intake, provide written nutrition information to customers upon request, state on menus that written nutrition information is available, and, for self-service foods (e.g., buffets), include calorie disclosures next to each food. The Secretary must pass regulations that establish how nutrition content will be disclosed for standard menu items that are offered in a variety of flavors or combinations (e.g., pizza, ice cream). Vending machines must bear calorie disclosures for each item offered for sale unless the Nutrition Facts panel for a food is available for the customer to view before purchasing food. FDA seeks input on a number of matters related to implementing the law, including: The types, sizes and nature of activities of chain restaurants, and size of chain vending machine operators; Current practices with respect to the use of menus and menu boards, including the disclosure of nutrition information on menus and menu boards; The disclosure of calorie content in self-service areas and for vending machine foods; The calorie disclosure statement to be established by the Secretary for addition to chain restaurant menus; Methods on how to achieve nutrition disclosure for menu items offered in a variety of flavors and combinations; Categories that should be exempt from the disclosure requirements; Estimated number of chain restaurants and vending machine operators that might be affected by the law and those that might voluntarily comply; How to determine calorie content of foods offered by chain restaurants; and How to display the Nutrition Facts panels on vending machines. The comment period closes on September 5.
Posted at 12:44 PM in Foods | Permalink
By Kurt R. Karst – Last week, the U.S. Court of Appeals for the Federal Circuit denied Lupin Pharmaceuticals, Inc.’s (“Lupin’s”) Petition for Rehearing en banc of a May 10, 2010 panel decision in Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc. in which the Court affirmed a May 2009 decision from the U.S. District Court for the District of New Jersey that the Patent Term Extension (“PTE”) granted by the U.S. Patent and Trademark Office (“PTO”) with respect to U.S. Patent No. 5,053,407 (“the ‘407 patent”) covering Ortho McNeil’s (“Ortho’s”) LEVAQUIN (levofloxacin) is valid. The Court’s May 2010 panel decision, which was issued on the same day as the Federal Circuit’s decision landmark PTE decision in Photocure ASA v. Kappos, and the Court’s July 2010 denial of Lupin’s rehearing petition leave standing an interesting dichotomy with respect to the treatment of single enantiomers in previously approved racemates insofar as the availability of PTEs and New Chemical Entity (“NCE”) exclusivity are concerned. Levofloxacin is an enantiomer in the previously approved Ortho racemate drug product FLOXIN (ofloxacin). Lupin initially challenged the ‘407 patent PTE in the context of ANDA Paragraph IV Certification patent infringement litigation on the grounds that the PTE is invalid because FDA previously approved the active ingredient levofloxacin when the Agency approved the racemate ofloxacin. (See our previous post here.)
Under the PTE statute at 35 U.S.C. § 156(a)(5)(A), the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, “the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.” The term “product” is defined at 35 U.S.C. 156(f)(2) to mean, in relevant part, “the active ingredient of – a new drug, antibiotic drug, or human biological product . . . including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient” (emphasis added). (The term “active ingredient” is defined in FDA’s regulations to mean “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body of man or of animals.”) For several years, the PTO had interpreted the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active moiety” (i.e., the molecule in a drug product responsible for pharmacological action, regardless of whether the active moiety is formulated as a salt, ester, or other non-covalent derivative) rather than “active ingredient” (i.e., the active ingredient physically found in the drug product, which would include any salt, ester, or other non-covalent derivative of the active ingredient physically found in the drug product). In contrast, the Federal Circuit’s 1990 decision in Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 13 USPQ2d 1628 (Fed. Cir. 1990) (“Glaxo II”), construed the term “product” in 35 U.S.C. § 156(a)(5)(A) to mean “active ingredient.” The Federal Circuit’s May 2010 decision in Photocure and Ortho-McNeil, both of which concerned the proper interpretation of 35 U.S.C. § 156(a)(5)(A), ruled that the Glaxo II decision and its “active ingredient” interpretation of the PTE statute should be applied for PTE purposes. In contrast, FDA has for decades, treated single enantiomers of previously approved racemates as previously approved drugs not eligible for 5-year NCE exclusivity (but eligible for three-year new clinical investigation exclusivity). For example, FDA stated in the preamble to its 1989 proposed regulations implementing the Hatch-Waxman Amendments that “FDA will consider whether a drug contains a previously approved active moiety on a case-by-case basis. FDA notes that a single enantiomer of a previously approved racemate contains a previously approved active moiety and is therefore not considered a new chemical entity.” FDA still adheres to this policy today, although the FDA Amendments Act of 2007 amended the FDC Act to add § 505(u), which permits the sponsor of an NDA for an enantiomer (that is contained in a previously approved racemic mixture) containing full reports of clinical investigations conducted or sponsored by the applicant to “elect to have the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug,” and thus be eligible for NCE exclusivity. The dichotomy between the treatment of enantiomers in previously approved racemates with respect to PTE and NCE exclusivity eligibility was at the heart of Lupin’s Petition for Reconsideration. Lupin argued that: The FDA and PTO abused their discretion when they applied two conflicting interpretations to the same words – “active ingredient” – in the same legislation – the “Hatch-Waxman Act.” Thus, the district court and the panel erred in failing to consider the important legal issue: what the term “active ingredient” means and how it should be applied to enantiomers. The Court should grant this petition for rehearing en banc to adopt and apply a consistent definition of “active ingredient” and to reverse the district court’s determination that the [PTE] was properly based on the approval of LEVAQUIN®, which contained the previously approved enantiomer, levofloxacin, as its active ingredient.
Posted at 01:12 PM in Hatch-Waxman | Permalink
By Kurt R. Karst – As the U.S. Senate Committee on Appropriations begins its markup and consideration of appropriations bills for Fiscal Year (“FY”) 2011, and in particular the Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill (S. 3606), rare and neglected disease (i.e., orphan disease) advocates appear to be poised to make big gains (once again!). The FY 2011 Senate bill includes a $2 million increase (for a total of $16,035,000) for FDA’s Orphan Product Development Grant program. The FY 2010 funding for the program was about $14 million, of which approximately $10 million funded noncompeting continuation awards, and approximately $4 million of which funded 10 to 12 new awards. The FY 2011 increase is the first since FY 2005. The FY 2011 Senate bill also includes funding of $1 million for the new Office of the Associate Director for Rare Diseases in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (“CDER”). FDA announced the position of Associate Director for Rare Diseases in February 2010. This orphan drug czar “will serve as CDER’s focal point to the rare disease drug development community and assist stakeholders and developers of drug and biologic products in navigating the complex regulatory requirements for bringing safe and effective treatments to patients in need.” The $1 million funding will be used to hire additional staff with specific expertise in facilitating the development and review of products to treat rare and neglected diseases. Finally, we understand that the manager’s package that will hopefully be adopted by the Appropriations Committee will include the provisions below, which are intended to build on § 740 of the Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act of 2010 (Pub. L. No. 111-80) co-sponsored by Senators Sam Brownback (R-KS) and Sherrod Brown (D-OH). As we previously reported, the Brownback/Brown amendment requires FDA to convene a committee of expert Agency employees to consider the ways FDA reviews products to treat people with rare and neglected diseases, and consider policy improvements that might help people with rare diseases get better treatments faster. The proposed language in the manager’s package (tentatively identified as § 741 in Senate Report 111-221 accompanying S. 3606) states:
The latest legislative push to address rare and neglected disease issues has been spearheaded by the National Organization for Rare Disorders (“NORD”) and Dr. Emil Kakkis’s Kakkis EveryLife Foundation. NORD has issued a press relase on the FY 2011 appropriations bill. The NORD Board of Directors is chaired by Hyman, Phelps & McNamara, P.C. Director Frank J. Sasinowski. There have been several events leading up to the appropriations bill language. On June 23, 2010, the Senate Appropriations Committee held a hearing to discuss FDA’s review process for products to treat rare and neglected diseases. That hearing was followed up by a two-day FDA public hearing on the same topic (see our previous post here). In addition, Representatives Joseph Crowley (D-NY) and Fred Upton (R-MI) recently announced the establishment of the Rare and Neglected Diseases Caucus.
Posted at 09:39 AM in Orphan Drugs | Permalink
Whistleblowers: A Potential Problem for Everyone
In the May/June 2010 edition of FDLI Update, HP&M Director John R. Fleder published his latest article on enforcement matters. This article is entitled “Whistleblowers: Treat Them With Kid Gloves.” The article addresses various issues that companies face when they are confronted with employees who raise complaints within a company about its compliance with regulatory requirements. The article discusses how one company benefitted from having generated contemporaneous documents that refuted allegations that a company employee (and potential whistleblower) had made about the company's alleged failure to comply with FDA-related requirements. The article also discusses the current government enforcement environment in which a large percentage of cases brought these days are based on whistleblower complaints. Finally, the article provides a number of practical suggestions for companies with regard to their treatment of potential and actual whistleblowers.
Posted at 05:27 PM in Enforcement | Permalink
Nestle Unit's Settlement with FTC Contains New Provisions Regarding Substantiation By Peter M. Jaensch – On July 14, 2010, the Federal Trade Commission (“FTC”) announced an agreement with Nestle HealthCare Nutrition, Inc. (“Nestle”) to settle an FTC investigation with regard to alleged false and misleading health claims. The FTC's Complaint arose from claims made by Nestle for its beverage product, BOOST Kid Essentials, which employs an attached straw to deliver probiotics to the drinker. According to the Complaint, Nestle claimed in various advertisements that clinical studies showed that the product (1) strengthened children’s immune systems, (2) reduced the duration of acute diarrhea in children, (3) reduced illness-related absences from school and childcare, and (4) reduced fevers among infants. The Complaint asserted that clinical studies did not support these claims. As part of the settlement, Nestle agreed to a Consent Order with some unusual, if not novel, provisions: (1) Nestle agreed not to claim that the product prevents or reduces the risk of upper respiratory tract infections, unless labeling for such claims is approved by the Food and Drug Administration under the Nutrition Labeling and Education Act of 1990. We cannot recall many, if any, prior FTC Orders or Injunctions that contain specific language that a company cannot make a claim unless the claim is approved by FDA. Instead, the FTC has, for years, included a provision in numerous health claim orders that exempt claims from coverage under an Order if the FDA has specifically approved labeling for that claim.
(3) In Part III of the Order, the FTC prohibits other claims from being made unless Nestle has adequate substantiation. It is interesting that for these other claims, the Order employs a totally different definition of what constitutes "competent and reliable scientific evidence." (4) It is also notable that although Nestle made the claims specifically for children up to age 13, the scope of the restrictions in the Order is not so limited.
Posted at 05:00 PM in Enforcement, Foods | Permalink
HP&M Attorney Elected to USP Expert Committee
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Diane B. McColl has been elected to the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs - Food Ingredients) for the 2010-2015 cycle. The committee develops new monographs and revises existing monographs and their associated reference materials for food ingredients, as well as for contaminants/adulterants, flavors and extracts, additives, and colorants. Ms. McColl, who is also a pharmacist, is the only attorney elected to the Expert Committee for the Food Chemicals Codex (Monographs - Food Ingredients). Additional information on USP Expert Committees is available here.
FTC Continues Focus on Cold and Weight Loss Supplement Claims, Settles with Iovate for $5.5M
On July 14th, the FTC announced the settlement of a significant false advertising case against Iovate Health Sciences U.S.A. and Canadian affiliates for false weight loss, cold, flu and allergy claims relating to 5 of the company's products. The settlement includes $5.5M for refunds to consumers, and represents a continuation of the FTC's focus on the weight loss and immune/cold/flu dietary supplement categories. The case illustrates two aspects of advertising that can be expected to result in increased scrutiny -- the use of actors dressed to look like doctors, and claims that products are "clinically proven." Just over one year ago, Iovate conducted a significant recall of one of its major products, Hydroxycut, as a result of adverse event reports that the product was associated with liver damage. Posted at 04:02 PM in Dietary Supplements | Permalink