Enforcement:
Dietary Supplement Manufacturers Fined for Marketing Anabolic Steroids
On January 17, DCD, LLC and R & D Holdings were fined $125,000 and $21,000 respectively, the amount of profits the companies received through the sale of products containing synthetic anabolic steroids or synthetic clones of anabolic steroids. Although the products were marketed as supplements, the steroid ingredients caused the products to be unapproved drugs.
DCD, doing business as Advanced Muscle Science, distributed Dienedrone and Liquidrone. R & D Holdings, doing business as Culver Concepts, Bradley Asgard and Bjorklund, distributed Orafinadrol 50, Microdol and Methyldrostanolone. As a condition of its probation, DDC, LLC and its subsidiary, Advanced Muscle Science, must implement a testing protocol to ensure that future products sold as dietary supplements do not contain synthetic steroids. R & D Holdings no longer manufactures or distributes supplements or drugs and is prohibited from doing so for two years.
FDA Issues Warning Letter for Cancer and Other Disease Claims
The Food and Drug Administration ("FDA") issued a warning letter to a supplement manufacturer on the grounds that its website claims established that the products are drugs. FDA objected to claims relating to cancer, anti-inflammatory properties, insulin sensitivity, glucose tolerance, improving cholesterol and venous insufficiency.
NAD Decisions:
Neutrogena “Rapid Wrinkle Repair"
January 17, 2012 - The National Advertising Division of the Council of Better Business Bureaus ("NAD") recommended that Neutrogena modify or discontinue certain claims for the company’s “Rapid Wrinkle Repair,” to avoid conveying the message that the product can eliminate wrinkles in just one week.
The NAD examined Neutrogena’s express claims, which included the following:
- "Most anti-wrinkle creams disappear long before the wrinkles. Until now. Introducing Neutrogena Rapid Wrinkle Repair";
- "It has Accelerated Retinol SA, which is the fastest retinol formula available"; and
- "In fact, it’s clinically proven to smooth wrinkles in just one week."
The NAD also reviewed Neutrogena’s implied claims. In its decision, the NAD noted that the advertiser’s evidence included superior testing and could support certain claims. However, the NAD stated that the fast-acting nature of the retinol does not necessarily support the claim that the product reduces or eliminates wrinkles in one week. NAD recommended Neutrogena discontinue this claim, but did determine that the Retinol claim was supported.
Proven Health Results,“Diab-X”
January 19, 2012 - The NAD determined that Proven Health Results took necessary and proper action in discontinuing a wide range of advertising claims for the company’s Diab-X dietary supplement. Such action included discontinuing all claims related to the prevention and treatment of diabetes.
The claims at issue were challenged before NAD by the Council for Responsible Nutrition ("CRN") as a part of an initiative to expand NAD review to advertising claims for dietary supplements. In response to the initial inquiry, Proven Health Results stated that it would discontinue use of all testimonials and all express or implied claims that the product, or its ingredients, can help reverse, prevent or cure diabetes.
The NAD noted in its decision that it was “very concerned over the strong health and medical benefit claims that originally appeared on the advertiser’s website.” Such claims included: “Imagine Your Life Free of Diabetic Risks” and “Defeat Diabetes Naturally!” However, the NAD did find that the advertiser provided a reasonable basis for some of its claims limited to ingredients. Finally, the NAD recommended that Proven Health Results stop its use of FDA logos to avoid the implication that the product or its ingredients are somehow certified.
Combe Incorporated (Vagisil Screening Kit)
January 19, 2012 - The NAD has recommended that Combe Inc. modify or discontinue certain advertising claims and more clearly disclose the limitations of its Vagisil Screening Kit. Claims were made by the advertiser in print, Internet, radio and television, and they were challenged before NAD by Johnson & Johnson Healthcare Products, Inc., which makes Monistat (treatment cream for vaginal yeast infections).
Some of the challenged claims included:
- “If you have symptoms of a yeast infection, know this. The STD trich has similar symptoms. So before you try Monistat, use the Vagisil Screening Kit. It can tell you if you have a yeast infection, or need to see a doctor. Don’t guess, test”; and
- “Many women who think they have a yeast infection don’t actually have one. In fact, two out of three women misdiagnose themselves.”
The NAD was particularly concerned by the alarmist tone of the challenged advertisements. It also determined that none of the cited studies could support claims that women with uncomplicated medical histories who have been previously diagnosed with a yeast infection currently misdiagnose their symptoms at a rate of 25-66%. Combe disagreed with NAD’s conclusions, but had already discontinued the television advertisements that were the principal focus of the proceeding and was in the process of changing the related website. Combe said it would consider NAD recommendations in future advertising.
Novartis Consumer Health, Inc. (Excedrin Extra Strength)
January 24, 2012 - The National Advertising Review Board ("NARB") has recommended that Novartis discontinue advertising claims that the company’s Excedrin Extra Strength product starts relieving headache pain faster than Advil. The claims were initially challenged before the NAD by the maker of Advil, Pfizer Consumer Healthcare. NAD determined that Novartis did not provide a reasonable basis to support its claim, and it recommended the claims be discontinued.
In its decision, NARB noted that when efficacy claims are made for pain-relief medication, “those claims must be supported by at least one adequate and well-controlled scientific study that measures efficacy in treating the type of pain for which efficacy is claimed, e.g., substantiation for claims involving relief of tension headache pain should include at least one scientific study that evaluates efficacy in treating tension headache pain.” Like NAD, the NARB found that the study results used by Novartis did not provide a reasonable basis for the general onset superiority claims and recommended Novartis discontinue such claims. Novartis released a statement saying it disagrees with both the NAD and NARB, but it will comply.
Ingredients:
U.S. Pharmacopeia Proposes Draft Standards for Probiotics
The U.S. Pharmacopeia has released new draft standards for probiotics to help ensure their quality. The proposal includes comprehensive information on testing to confirm identity, microbe count, purity, safety, intended uses in food, and regulatory status. The draft standards will be included in the Food Chemicals Codex. A public comment period closes March 31, 2012.
Go here for more information.
New Cosmetic Ingredients Required to be Listed Under Prop 65
On January 20, 2012, California's Office of Environmental Health Hazard Assessment ("OEHHA") issued a notice of its intent to list benzophenone, cocamide diethanolamine, and diethanolamine as chemicals known to cause cancer under California's Proposition 65. Once listed, any product in California containing one of those chemicals must carry a warning label unless exposure is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. This potentially poses significant problems for the cosmetics industry where these three chemicals are commonly used. OEHHA is receiving comments on the issue until February 21, 2012.
Go here for more information.
Proposed Rules and Guidance Open for Comment:
FDA Reopens Comment Period for Direct-to-Consumer Prescription Drug Advertisements Proposed Rule
FDA is reopening the comment period on a proposed rule on direct-to-consumer television and radio advertisements that would establish standards to be considered in determining whether the major statement relating to the side effects and contraindications of an advertised prescription drug is presented in a clear, conspicuous, and neutral manner. FDA is seeking comments on a study entitled: ‘‘Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements.” This study was designed to investigate some advertising factors that could influence consumers’ understanding of a drug’s risks. Any new comments must be submitted by February 27, 2012. A full version of the Federal Register notice can be found here.
FDA Soliciting Comments on Selenium Health Claims Study
FDA has announced that it is soliciting comments on a study entitled “Experimental Study of Consumer Response to Health Claims and Disclaimers about the Relationship between Selenium and Risk of Various Cancers.” Any comments must be submitted by March 27, 2012. A full version of the Federal Register notice can be found here.
FDA Announces New Guidance for Industry on Prescription Drug Labels
FDA has announced the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Advertising and Promotion Labeling.” The Guidance is intended to clarify for applicants the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human and animal drugs and biological products. Comments can be submitted at any time. A full version of the Federal Register notice can be found here. The Guidance itself can be found here.
FDA Releases Three Guidance Documents on Biosimilars
FDA has announced the availability of three guidance documents on biosimilar product development.
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
This draft guidance addresses FDA’s basic scientific approach to determining biosimilarity in the review of a biosimilar application, which FDA refers to as a “351(k)” application. The document describes a risk-based “totality-of-the-evidence” approach that the FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity, and recommends a stepwise approach in the development of biosimilar products.
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
This draft guidance addresses analytical factors related to demonstrating biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a “351(k)” application. The document describes the importance of extensive analytical, physico-chemical and biological characterization in demonstrating that the proposed biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.
This draft guidance addresses a number of issues related to biosimilars in a question-and-answer format. The document addresses issues related to biosimilarity, interchangeability, exclusivity, and the “biological product” definition. It includes both substantive advice and practical advice on how to address these issues with the agency through meetings and otherwise.
FDA is seeking comments on these guidance documents by April 16, 2012.