FDA and the cosmetic industry recently separated ways as their talks to modernize how FDA regulates cosmetics collapsed. In March, FDA expressed a “profound disappointment” with the legislation proposed by the cosmetic industry and implied that FDA would proceed without industry input. The industry responded that FDA misunderstood the proposed legislation and asked the Agency to return to the table.
Thus far the table appears empty, and industry is looking to work with Congress (who would have to pass changes to the law anyways).
How FDA regulates cosmetics has remained essentially the same since Congress passed the Food, Drug, and Cosmetic Act in 1938. In the last 75 years, the laws regulating foods, drugs, and medical devices have been updated several times, while cosmetics stayed the same.
Consumer advocacy groups are increasing, and focusing their attention on how FDA will regulate cosmetics after the passage of the Food Safety Modernization Act (FSMA). Although it is not clear when, in the nearish future we anticipate that Congress will update how FDA regulates cosmetics. What will be the final catalyst remains unforeseen.
This new regulatory regime will likely include:
- Premarket review of ingredients
- Good manufacturing requirements
- Facility registration
- Serious adverse event reporting requirements
- Recall authority
- User fees to pay for the new regime (which will be expensive)
