What Warren G and the FDA Have in Common
Minimizing Product Liability Risk for Life Sciences Companies
Nate Dogg and Warren G had to regulate, and when it comes to vitamins and dietary supplements, so does the FDA. So, how are these products regulated? Are they the same as pharmaceuticals or medical devices? The short answer is no, and here’s why.
Unlike the biotech, pharmaceutical and medical device industries, the Food and Drug Administration (FDA) deems a supplement as safe until it’s proven unsafe. Many vitamins and dietary supplements don’t always go through a clinical trial or verification of ingredients (although ones with a USP seal of approval do). The FDA might not approve dietary supplements, but they can regulate them – along with the Federal Trade Commission (FTC) – once it’s on the shelves of a store being sold.
With the many failure to warn claims, death claim litigations with various products with caffeine powder and the few bad apple companies out there, the FDA is continuing to take notice.
So, how can companies minimize product risk? There are many concerns when operating a company in general, but there are some unique inherent risks when working in an industry that has an ever-evolving regulatory and litigation landscape. Many companies are concerned about their D&O exposure as it relates to the potential for bodily injury from one of their products. Dietary supplement companies can minimize their product liability risk by:
- Following the dietary supplement Current Good Manufacturing Practices (CGMPs) and requiring everyone in your supply chain, like your contract manufacturers, to learn and follow the same principles
- Working with accredited agencies for dietary supplement certifications of those manufacturing principles and ingredient certifications such as NSF or USP
- Choosing the right risk management partners from the panel counsel and regulatory affairs firm to a broker who truly understands the dietary supplement industry
- When it comes to the supplement industry, it’s imperative to understand both domestic and foreign product liability exposures and coverages, claims management, product recall and withdrawal as well as advertising injury
Dietary supplements play an extremely important role and should be considered in the holistic sense, yet the fly-by-night infomercials and companies lying about ingredients will continue to put pressure on the mega-growth industry.
As this industry continues to grow you'll see an increase in regulation by the FDA of new ingredients. There will be tighter controls on the dietary supplement CGMPs and a potential of industry self-imposed evidence-based efficacy studies such as clinical trials. Nonetheless, following these tips and minimizing your product liability will help your company to be prepared for what may come.
For more information on how to minimize risk for your life sciences company, contact us.
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