- This week, FDA kicked-off a new resource about the Modernization of Cosmetics Regulation Act of 2002 (MoCRA) and a follow-up constituent advisory that FDA has stopped accepting and processing submissions to the Voluntary Cosmetic Registration Program (VCRP). FDA is developing a program for submission of the facility registrations and product listings required by MoCRA which we will continue to monitor and provide updates on.
- FDA approved the first naloxone product approved without a prescription: Narcan (4 mg), naloxone hydrochloride nasal spray for Over-the-Counter (OTC), non-prescription use. Naloxone is the standard treatment for opioid overdose, and increasing its access to consumers is anticipated to address the dire public health need. FDA is encouraging manufacturers to make the product’s accessibility and affordability a priority, and is working with stakeholders to facilitate the prescription to OTC switch.
- On the FDA enforcement side, FDA issued a Warning Letter to Cosmetic Science Laboratories, LLC, alleging significant violations of cGMPs for finished pharmaceuticals (21 CFR Parts 210 and 211). Specifically, FDA found that the Company’s manufacture of various Over-the-Counter (OTC) sunscreen products failed to comply with API identity testing prior to manufacture, production and process controls, and manufacturing operations for out of specification results and non-conformances.
FDA also issued a Warning Letter to Wise Spice Catering Company for violations of cGMPs and Preventative Controls under 21 CFR Part 117. Specifically, FDA reported presence of L. monocytogenes in various areas of the facility and in the preparation of RTE closed faced sandwiches. Additionally, FDA found that the Company’s packing and holding areas failed to protect against the contamination of food by pests, facility structure and design and general sanitation.
Additionally, FDA published a Warning Letter to Nara Company, Ltd., for failure of a processor of fish or fishery products to have and implement a HACCP plan, and a Warning Letter to Vanlaw Food Products, Inc. for failure to declare major food allergens on finished product, and alleged failure to comply with CGMP and Preventive Controls under 21 CFR Part 117.
We remind companies to ensure that their operations, whether it is holding and storage, manufacture, or packaging, comply with requisite cGMP requirements via mock-audits, third-party inspections, SOP review and staff training to mitigate public health concerns and FDA enforcement risk. We also remind food Companies to ensure proper disclosure of allergens and cGMP and PC compliance to avoid FDA recalls and other enforcement.
