Cosmetic companies are also now required to maintain records of, and report, adverse events. FDA requires these records to be available should any of your products pose a potential threat to public health. Upon identification of a threat, FDA now reserves the right to enforce detentions, refusals, and mandatory recalls of these products.
Cosmetic serious adverse event reporting must be conducted and submitted to FDA within 15 business days — including any updates that follow within a year of the original submission.
Adverse events are also required to be accepted through a U.S. address, telephone number, or electronic contact information supplied on each of your product labels.
Section 605 of MoCRA also expanded FDA’s definition of a serious adverse event to better cover cosmetics as a whole.
The definition now includes:
- Significant disfigurement, including serious and persistent rashes
- Second or third-degree burns
- Significant hair loss
- Persistent or significant alteration of appearance
Records of adverse event reports must be maintained for 6 years, and FDA must be able to access them during inspections.
If considered a small business, the responsible person is required to maintain records for no less than 3 years. The FDA categorizes small businesses as those whose average annual gross sales have not exceeded $1,000,000 over the past three years for cosmetic products marketed in the U.S.
If the FDA suspects that an ingredient or a mix of ingredients in the product's fragrances or flavors has led to severe adverse events, it may ask for a written list of all the ingredients. This list must be submitted within 30 days of FDA’s request.