By Kurt R. Karst –
On November 18, 2015, Representative Peter Sessions (R-TX) introduced H.R. 4075, the Cosmetic Modernization Amendments of 2015, to little fanfare. The bill continues a recent trend among legislators (both federal and state) to attempt to legislate in the personal care products space. In addition to the Cosmetic Modernization Amendments of 2015, there’s the Microbead-Free Waters Act of 2015 (S.1424 and H.R.1321) that would begin a phase-out of synthetic microbeads used as exfoliants in some personal care products, and the Humane Cosmetics Act (H.R. 4148) that would phase out animal-based testing for cosmetic products in the United States. There have also been other bills in recent years that, like H.R. 4075, are broad in scope insofar as FDA regulation is concerned. There’s the Safe Cosmetics and Personal Care Products Act of 2013 (H.R. 1385), the Cosmetic Safety Amendments Act of 2012 (H.R. 4395) (see our previous post here), the Safe Cosmetics Act of 2010 (H.R. 5786) (see our previous post here) and the more recent Personal Care Products Safety Act of 2015 (S. 1014) (see our previous post here).
The Cosmetic Modernization Amendments of 2015 is a pared down version of some of the “Safe Cosmetics” bills mentioned above. H.R. 4075 would amend the FDC Act to add several new sections and would redefine cosmetics as we know them under the FDC Act.
Proposed Section 605 would require FDA to promulgate regulations requiring that every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be sold in the United States, and that is not otherwise exempt under another section of the bill (e.g., beauty shops, spas, and cosmetic retailers), be registered with FDA within 60 business days after the first commercial sale of a cosmetic in the United States. FDA would provide each registrant with a unique “cosmetic establishment registration number” and would create a publicly available list of registered establishments.
Proposed Section 606 would require FDA to promulgate regulations requiring that every domestic establishment and foreign establishment engaged in the manufacture of a cosmetic intended to be sold in the United States to submit to the Agency a “cosmetic and ingredient statement” for each cosmetic manufactured in the establishment (except for cosmetics manufactured by establishments exempt from registration) within 60 business days after the first commercial sale of the cosmetic. The statement would include the unique establishment registration number of each manufacturing establishment where the cosmetic is manufactured, the brand name(s) for the cosmetic, the applicable cosmetic category or categories for the cosmetic, the ingredients in the cosmetic, and establishment contact information. FDA would be required to use the statement information to compile and maintain an up-to-date and publicly available electronic list of cosmetics and ingredients.
Proposed Section 607 would require FDA to promulgate regulations requiring that a domestic or foreign manufacturer, packer, or distributor whose name appears on a cosmetic label to submit to FDA 15-day adverse event reports. Specifically, such reports would include “information received concerning any serious and unexpected adverse event in the United States allegedly associated with the use of the cosmetic for which it is reasonably likely that the adverse event was caused by the cosmetic when used as recommended or suggested in the labeling,” and “a copy of the label for the cosmetic.” The bill states specifically that such adverse event reports “shall not be construed as an admission that the cosmetic involved caused or contributed to the adverse event,” and that they “may be accompanied by a statement that denies that the report constitutes an admission that the cosmetic involved caused or contributed to the adverse event.”
Proposed Section 608 would permit FDA to establish by regulation “principles and standards for good manufacturing practice for the manufacture of cosmetics” in accordance with FDC Act §§ 601(a) and (d), which sections specify when cosmetics are adulterated.
Proposed Section 609 would provide what ingredient and nonfunctional constituent categories are “deemed to be adequately substantiated for safe use in cosmetics subject to the requirements of good manufacturing practice.” Safe ingredients include:
- Color additives approved by [FDA] for use in cosmetics, within any limits established in such approval;
- Food additives approved by [FDA] for direct addition to food for human consumption, within any limits established in such approval;
- Food ingredients that have been determined by [FDA] to be generally recognized as safe for direct addition to food for human consumption, within any limits established in such determination;
- Food ingredients for which monographs have been included in the Food Chemicals Codex for direct addition to food for human consumption, within any limits established in such monographs;
- Pharmaceutical excipients and inactive ingredients approved or permitted by the Secretary, listed on a [FDA] website for use in drugs for human consumption or for which monographs have been included in the Handbook of Pharmaceutical Excipients, within any limits established in such lists or monographs;
- Cosmetic ingredients that have been reviewed for safety by a qualified nongovernmental or governmental expert scientific body, including the Cosmetic Ingredient Review Expert Panel, and that are the subject of a monograph published in a peer-reviewed scientific journal, within any limits established in such monographs;
- Fragrance ingredients that have been reviewed for safety by a qualified nongovernmental or governmental expert scientific body, including the Research Institute of Fragrance Materials Expert Panel, and that are the subject of a monograph published in a peer-reviewed scientific journal, within any limits established in such monographs; and
- Cosmetic ingredients approved or permitted for use in cosmetics by any of the countries listed in section 802(b)(1)(A) as having an adequate regulatory authority, within any limits established by such regulatory authority.
Safe nonfunctional constituents are those that fall within certain levels specified in the bill. For example, “[t]he levels approved or permitted for nonfunctional constituents by [FDA] for color additives for cosmetic use and for food additives and generally recognized as safe food ingredients for direct human consumption,” and “[t]he levels approved or permitted for nonfunctional constituents by [FDA] or the United States Pharmacopeia for oral nonprescription drugs.”
FDA would also be required to establish within the Center for Food Safety and Applied Nutrition a program “to evaluate and make determinations, by regulation, on the safe use of cosmetics and ingredients and nonfunctional constituents thereof.”
The Cosmetic Modernization Amendments of 2015 includes several smaller provisions – at least in length (but not in effect) – concerning myriad topics, including requiring the establishment of a “National Cosmetic Regulatory Databank” containing various pieces of information required to be submitted to FDA under the bill, providing when the importation of a cosmetic may be denied, and, importantly, revising FDC Act § 752 to rename it “National Uniformity for Cosmetics” and to make modifications concerning the scope of the preemption provision (think preemption of California Proposition 65). Also tucked away in a section of the bill titled “Special Rules” is an attempt to redefine the term “cosmetic.”
Currently the statute defines the term “cosmetic” at FDC Act § 201(i) to mean:
(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
The Cosmetic Modernization Amendments of 2015 would amend that definition as follows:
(b) Cosmetic definition.— Section 201(i) (21 U.S.C. 321(i)) is amended by adding at the end the following: “An article described in subparagraph (1) that is intended only for topical external use to alter the appearance by temporarily affecting the structure or any function of the human skin, and that is not the subject of an approved new drug application under section 505, shall, for purposes of this Act, be treated only as a cosmetic and not a drug.”
If this definition is enacted, it would significantly change the historical line defining the boundary between drug claims and cosmetic claims for topical products, pushing some claims that are now drug claims over into cosmetic territory.