PCPC/FDA Briefing: VOCs, HEMP, PFAs, Talc and the Safe Cosmetics Act

VOCs, hemp, 1,4-dioxane, talc, inclusion, transparency, PFAs in cosmetics, formaldehyde, allergens, and elements of the Safe Cosmetics Act are among the top current areas of focus for the Personal Care Products Council (PCPC) and the U.​S. Food and Drug Administ­ration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN). During the session, Tom Myers, executive vice president of legal and general counsel for the PCPC, emphasized the many challenges the personal care industry is facing.

Also, Myers described current initiatives including collabor­ations with the California Air Resources Board (CARB) to set emission level standards for products such as dry shampoos, fragrance, and other sprays—which, for some companies, means reformul­ation.

In addition, a listing of both hemp (marijuana) smoke and THC as reproductive toxins requires warning labels. “Hemp smoke is not a concern to cosmetics,” he said, “but THC is, as it [may be present in] hemp, which is a potential ingredient for use in cosmetics.”

On the East Coast, Myers emphasized limits set by the state of New York for 1,4-dioxane levels due to concerns over human health and its persistence in the environment. On the environmental front, Myers sees the next big area of concern being plastics and packaging.

PCPC/FDA Briefing: VOCs, HEMP, PFAs, Talc, and the Safe Cosmetics Act

VOCs, HEMP, 1,4-dioxane, talc, inclusion, transparency, PFAs in cosmetics, formaldehyde, allergens, and elements of the Safe Cosmetics Act are among the top current areas of focus for the Personal Care Products Council (PCPC) and the U.​S. Food and Drug Administ­ration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN).

Finally, Mayne outlined elements and challenges posed by the currently proposed Safe Cosmetics Modernization Act. The primary elements include:

Mandating the registration and listing of products and ingredients;

Giving explicit authority to establish GMPs by regulation;

Mandating serious adverse event reporting;

Mandating access to records including consumer complaints during routine or for-cause inspections;

Mandating recalls;

Requiring the disclosure of known cosmetic allergens on product labels;

Requiring ingredient reviews; and

Requiring sufficient resources to implement these protections.

The challenges currently faced include the FDA’s limited legal authority, competing agency priorities, and the significant changes occurring over the past 15 or more years. Regarding the latter, Mayne points to companies manufacturing more globally; utilizing animal alternatives for testing; and developing increasingly sophisticated ingredients with the potential to cause structure and function effects in the body (i.e., nanotech, “active” ingredients, microbiome and probiotic products, hemp, etc.).