Proposed Safety Act May Expand FDA Authority Over Cosmetics

Two senators recently introduced a bill that could significantly increase FDA’s authority over cosmetic and personal care products within the United States. The Personal Care Product Safety Act, proposed by Sens. Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine), is a nearly 100-page bill that addresses facility and product registration, FDA’s authority to issue mandatory recalls, adverse event reporting (AERs) and good manufacturing practices (GMPs).

Under the bill, companies would need to report serious adverse events, such as death and life-threatening experiences, within 15 business days, while non-serious adverse events would need to be reported in an annual report. FDA would also have the authority to order recalls of personal care products deemed as threatening to consumer safety. In addition, the association could require labeling of products containing ingredients considered inappropriate for children, or ingredients that should be professionally administered. Companies would need to post complete label information online (including ingredients and product warnings). The new act would also require cosmetic product manufacturers to register with FDA each year and to provide the agency with ingredient information used in their products. FDA could also issue regulations on GMPs for personal care products.

In addition to these changes, the bill would begin an FDA safety investigation of at least five personal care ingredients each year, according to a blog post from Riëtte van Laack, director, Hyman, Phelps & McNamara, who provides regulatory counsel on foods and dietary supplements, over-the-counter (OTC) drugs, cosmetics, and animal feed and drugs. The first year’s study would include research on propylparaben (often used as a preservative in cosmetics); methylene glycol (a chemical previously used in hair products, which releases formaldehyde); diazolidinyl urea (a preservative used in shampoo and conditioner), Quaternium-15 (a preservative used in shaving cream and skin creams,) and lead acetate (used in hair dye). 

Van Laack said if the act is implemented, the estimated cost would amount to US$20.6 million each year, which would be covered by registration fees. The bill would determine the registration fee based on the gross annual sales from companies’ cosmetic products. Therefore, fees would vary from $250 to $1.1 million.

“It is evident that there is a pendulum swing back toward greater FDA oversight of dietary supplements, cosmetics and now homeopathics," Loren Israelsen, president of the United Natural Products Alliance (UNPA), said in a UNPA member memo. “The question is whether this is a blip or a major trend."

Israelsen added that this topic will be discussed further at UNPA’s 2015 Members Retreat in Scottsdale, Arizona, May 11 to 14.