For the full version, read the April edition of C&T magazine
The U.S. Food, Drug & Cosmetics Act was enacted in 1938 and has not been significantly updated since then. In the last several years, a variety of bills has been introduced to modernize the act but none were passed. In a surprise move, however, the Modernization of Cosmetics Regulation Act (MOCRA) was written into H.R. 2617, the Consolidated Appropriations Act, on Dec. 23, 2022; and on Dec. 29, President Biden signed H.R. 2617 into law. The 1,653-page bill includes 14 pages on cosmetics. Importantly, the original 21 U.S.C. 361 et seq. was not changed as far as major provisions are concerned, only added to; following is a synopsis. Note that he information provided should not be construed as legal advice. Also, language within MOCRA that could cause issues or confusion has been emphasized in bold by the author.
Section 604: Definitions
- Adverse Event – Any health-related event associated with the use of a cosmetic product that is adverse.
- Authorized Person – An officer or employee of the Department of Health and Human Services who has appropriate credentials, as determined by the Secretary, and has been duly designated by the Secretary to have access to Adverse Event or Serious Adverse Event records.
- Cosmetic product – A preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
- Facility – See below.
- Professional – An individual who is licensed by an official state authority to practice in the field of cosmetology, nail care, barbering or esthetics.
- Responsible Person – The manufacturer, packer or distributor of a cosmetic product whose name appears on the label of the cosmetic product.
- Serious Adverse Event – An event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual, or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described [above].
Section 605: Adverse Events
Companies must keep records of all Adverse Events reported. They may voluntarily report such events but it is not mandatory. Serious Adverse Events must be reported to the U.S. Food and Drug Administration (FDA) by the Responsible Person within 15 days and must include the product label. Updated information received on the Serious Adverse Event must be submitted to the FDA within one year from the time it was received by the Responsible Person. Companies must be sure to include, with each submission, a statement that the report or the records do not constitute an admission that the product involved caused or contributed to an Adverse Event or Serious Adverse Event. The contact information on the product label should be sufficient for the submission of Adverse Events or Serious Adverse Events to the Responsible Person. Generally, records must be kept for six years although for small businesses, as defined below, the requirement is only three years.
Important note: Note the importance of having a Standard Operating Procedure (SOP) in place for Adverse Events and Serious Adverse Events. Be sure to include the date each piece of information is received as it asserts the time limit. Additionally, the Authorized Person must have access to Adverse Event and Serious Adverse Event records. If the FDA finds the fragrance or flavor in a company's product may have contributed to a Serious Adverse Event, the company is required to provide the FDA with a list of the fragrance/flavor ingredients or categories of ingredients within 30 days. This information is important to have on file ahead of time to ensure compliance, should the need arise.
For the full version, read the April edition of C&T magazine
