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October 22, 2012

Avon Wrinkle Care Receives Warning Letter from FDA

antiaging.jpgOn October 5, FDA sent a warning letter to Avon Products, Inc. ("Avon") concerning the cosmetic company's online promotion of its anti-aging skin care products. The letter, which FDA posted last week, objects to Avon's marketing claims for a variety of its anti-wrinkle products. Specifically, it warns that they "appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act ['FD&C Act']."

The cited statutory provision (21 U.S.C. § 321(g)(1).) defines "drug" to include "articles (other than food) intended to affect the structure or any function of the body of man or other animals." FDA asserts that Avon's marketing claims indicate that the creams and serums listed in the letter are intended to affect the structure of human skin tissue, in which case they would fall under that definition. For example, the company's website describes that the Anew Clinical Advanced Wrinkle Corrector as "formulated to boost shock-absorbing proteins to help strengthen skin's support layers," and "start rebuilding collagen in just 48 hours." While it is not out of the ordinary for anti-wrinkle products to claim to reduce the appearance of wrinkles and fine lines, FDA believes that Avon's statements go too far. According to the letter, the products are "not generally recognized among qualified experts as safe and effective for the above referenced uses" and are thus new drugs, requiring marketing approval.

Written by Rachael P. McClure

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Congress has prohibited the introduction of new drugs into interstate commerce without filing, and subsequent approval of, a new drug application ("NDA") as stated in 21 U.S.C. § 355(a). A new drug application ("NDA") must include, among other things, "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use." Id. at § 355(b)(1). Other requirements address labeling information and manufacturing controls. Id. The warning letter asks Avon to review its website and product labels and requests a response within 15 days of receipt (October 20) detailing the steps the company has taken to correct the alleged violations. At least some of the accused descriptions still seem to remain on Avon's website.

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July 6, 2012

Nanotechnology: User Fee Bill Increases Funding for FDA Studies

nanotechnology.bmpThe Food and Drug Administration Safety and Innovation Act, otherwise known as the User Fee Bill, has passed through Congress and awaits the President's signature. This Bill, mostly known for implementing user fees for generic drug applications, also provides new programs to foster the study of nanomaterials in products regulated by FDA. Section 1126 of Title XI, Subsection C calls for the Secretary to "intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials, ... to address issues relevant to the regulation of those products, including potential toxicology, the potential benefit of new therapies derived from nanotechnology, the effects of nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems." This provision mirrors the Nanotechnology Regulatory Science Act of 2011 introduced by Sens. Ben Cardin (D-MD) and Mark Pryor (D-AR) last year, which stalled after its introduction in the Senate.

Nanomaterials utilize nanotechnology--manipulation of matter on the atomic and molecular scale. Nanomaterials, measured in billionths of a meter, range from 1- 100 nanometers (nm) and are used in a range of products, from paint and sunscreen to drugs and cosmetics. In 2010, the National Science Foundation estimated that nanotechnology-based products and manufacturing would add 2 million jobs and $1 trillion dollars in revenue to the world economy by 2015. These nanoproducts have different physical, chemical, and biological properties than conventionally-scaled materials, and some speculate that these properties may involve unknown risks to humans and our environment.

Written by Caroline Bercier

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The importance of nanomaterials has been recognized for some time. President Clinton advocated nanotechnology research, and President George W. Bush increased funding for nanotechnology development in 2003 with the passage of The 21st Century Nanotechnology Research and Development Act. However, this will be the first time that Congress has mandated that FDA study nanotechnology to evaluate the safety and toxicity of nanomaterials in consumer goods and products.

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February 14, 2012

Valentine's Kisses Can Lead to Lead Exposure?

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Thumbnail image for lipstick.bmpOn February 7, a week before Valentine's Day, Janet Nudelman, representing the nonprofit coalition of environmental- and cancer-prevention groups, the Campaign for Safe Cosmetics ("CSC"), once again wrote to FDA, asking FDA to take follow California and Canadian health authorities and set safe limits of lead in lipstick. The letter notes that while FDA maintains certain information on its website about lead in lipstick, e.g., a "Is there lead in lipstick?" page and December 5, 2011 updated "Lipstick and Lead: Questions and Answers" page, FDA has not conducted a formal assessment of lead in lipstick nor determined safe limits.

FDA's Questions and Answers explains that while FDA sets specifications for lead in color additives used in cosmetics (currently no more than 20 parts per million ("ppm"), FDA does not set limits for lead in cosmetics nor conduct any pre-market approval of cosmetics that could lead to uncover total amounts of lead in lipsticks. FDA stated that since the 1990s it has been aware of traces of lead in lipsticks, which was highlighted again principally by CSC in 2007. As a result of CSC's report, FDA tested in 2007 some 400 lipstick brands, concluding none of them were unsafe, falling all below the more conservative 5 ppm limit recommended by the State of California and below the 10 ppm limit set by Health Canada, which has draft guidelines on impurities in cosmetics. The original study appeared in a July/August 2009 Journal of Cosmetic Science article.

FDA updated its data from a survey of lipsticks from February to July 2010, which will be published in the May/June 2012 issue of the Journal of Cosmetic Science, FDA's Questions and Answers states. What concerned CSC was that left without specific FDA guidelines or lead limits, lead levels in some lipsticks have more than doubled when compared to the maximum amounts found in 2007 (e.g., in 2007, Cover Girl/Procter & Gamble and Revlon sold lipsticks with just over 3 ppm lead, whereas in 2010, Maybelline/L'Oréal sold brands with 7 or more ppm (exceeding the California guideline but still less than Health Canada), despite a majority having levels below 5 ppm). Also, CSC pointed out that FDA's study demonstrated that it is possible to manufacture lipsticks with lead levels as low as 0.03 ppm, suggesting that FDA could limit lead levels to below Health Canada's limits, perhaps approaching the 0.03 ppm mark. CSC analogized this to maximum allowed lead limits in candy that is set to 0.1 ppm "not because that limit is considered safe but because FDA determined that level to be the lowest level candy manufacturers can feasibly achieve."

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