In response to the recently proposed Personal Care Product Safety Act, the United Natural Products Alliance (UNPA) has called for input to better serve companies that would be affected by the bill.
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). If passed, the bill could significantly increase FDA’s authority over cosmetic and personal care products within the United States.
Loren Israelsen, UNPA president, said the organization has been in discussion with cosmetic trade associations and NSF to “assess the prospects of this bill and its effect on companies manufacturing or selling cosmetics." UNPA issued a survey to the industry to identify which companies would be affected, pinpoint any major concerns and determine if a UNPA working group on cosmetic legislation/regulation would helpful. Companies manufacturing or selling cosmetics are encouraged to participate.
“It is evident that there is a pendulum swing back toward greater FDA oversight of dietary supplements, cosmetics and now homeopathics," Israelsen said in a previous member memo. “The question is whether this is a blip or a major trend."
In addition to the changes discussed above, 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. 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.