"Invite-Only" Compliance Is Over: Is Your Cosmetic Company Ready?

 The "handshake" era of cosmetic compliance is officially over. Under new authorities in Sections 605, 610, and 704, the FDA has moved from simple observation to an aggressive "access and copy" mandate. In this episode, Darshan Kulkarni breaks down the "SAHCOD" threat and explains why your internal communications, medical assessments, and even cross-contamination logs are now fair game for federal investigators. If you handle raw materials or shared manufacturing equipment, your entire catalog could be at risk of a forensic audit. Learn where the FDA's power ends—and where your defense begins. 

Transcript

Darshan 0:00

Compliance just lost its invitation-only status for cosmetics. Under the new established authorities of Section 605, 610, and 704 of the Food, Drugs, and Cosmetics Act, FT has just moved past simple observation to an aggressive access and copy mandate. Section 605 focuses on mandatory adverse event reporting. 610, now that's where the real game changer is. It grants the FT authority to demand records the moment they have a reasonable belief that a product or ingredient presents a threat of serious adverse health consequences or death. You might see called S-A-H-C-O-D. This is an expansion of the investigational and inspectional authority that places your internal files directly in the hands of federal investigators. Just because there's a guidance doesn't mean that it's binding. So be careful of that. Having said that, adverse event logs are now no longer just annual reviews. The FDA now expects that a comprehensive history for every single health-related event associated with your products is being kept. You must have a responsible person, and this person must maintain records for a minimum of six years after creation. Now, certain businesses may qualify for a three-year window, but that is unique. This archive must include not just the final report, but every scrap of communication with the claimant and your internal medical assessments used to determine if this event was serious. Now, you want to be careful. But this means that if one of your products has a contaminated raw material that can trigger a forensic audit of your entire catalog, you must be tracking that information. So if you share manufacturing equipment, you use common suppliers for containers or closures or even process products in close proximity where cross-contamination is possible, those records are now fair game. The FDA is looking for systemic process deficiencies like failure in sterilization or pH adjustment that can turn a localized issue into a multi-brand disaster. Enjoying our content? Refusing access to mandated records is still a prohibited act, but there are limits to Section 610 authority. For example, it generally excludes your secret recipes, financial data, and pricing structures. Failure to comply can result in civil actions, criminal prosecution, or effectively ban your products from entering the US state andor entering US commerce. Now, if you have questions about this and how it applies to you, reach out to me at the Kilkani Law Firm. I'd be happy to help guide you through this. Call, click, or email.