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INSIGHTS

March 30, 2023

FDA Roundup: The Latest Activity

  • 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.

★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
R.G. Client
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Mike H. Client
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
Dr. Sastry Client
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
Claire P. Client

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