Background
This legislation was introduced in the 114th Congress by Senator Dianne Feinstein (D-CA) on April 20, 2015 as S. 1014.
The legislation would amend the Federal Food, Drug and Cosmetics Act (FFDCA) to require cosmetics companies to register their facilities with FDA and to submit to the FDA cosmetic ingredient statements that will include the amounts of each ingredient contained in each product. Cosmetic companies would be required to pay a facility registration fee based on the annual gross sales of the cosmetics of that company. All collected fees will be used for cosmetics safety activities.
The legislation was developed to provide clear mandates on Good Manufacturing Practices (GMPs), funding for associated facility inspections, and to tie funding to enforcement of cosmetics.
S. 1014 was co-sponsored by Senators Susan Collins (R-ME), Barbara Boxer (D-CA) *, Amy Klobuchar (D-MN), Mark Kirk (R-IL) *, Mazie Hirono (D-HI), and Kirsten Gillibrand (D-NY). Kirk and Boxer have since then left office.
Issue
Currently, there is only a GMP guidance, not a final rule, for cosmetics regulation. Any FDA guidance document is not legally binding and does not have the force of law. Only formal rulemaking through public notice and comment will provide effective enforcement of GMPs in the cosmetics industry.
In the absence of a formal definition for the term “natural” in the cosmetics industry, U.S. courts are left to rule on the legitimacy of natural claims. False-advertising class actions have increased in the personal care space, following a similar trend that began in the food sector. Once FDA defines the term “natural,” it will alleviate the current backlog of congestion in the courts and future potential lawsuits from the Plaintiff’s bar over use of the term and how it is perceived by consumers.
NPA Position
NPA supports a cosmetics bill that will include mandatory GMPs to be issued for the cosmetics industry in the form of final rulemaking and comment.
NPA believes better clarity over the term “natural” will be positive for the cosmetic industry and consumers and strongly urges the 115th Congress to push for the FDA, under the Trump Administration, to finally define the term in personal care products. NPA defined “natural” for personal care products. Since then, more than 1,300 products and ingredients have been certified under the NPA Natural Standard.
