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).
The Safe Cosmetics Act of 2010 would maintain current FDC Act §§ 601-603 concerning adulterated and misbranded cosmetics, but would amend the FDC Act to add a new subchapter on the regulations of cosmetics. H.R. 5786 would, among other things:
- 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.