Nutritional Outlook recently had an interesting article about the concerns of an adulterated sports nutrition ingredients. Multiple organizations have partnered with the U.S. Anti-doping Agency (USADA) to prevent the unlawful development and distribution of bodybuilding products that contain selective androgen receptor modulators (SARMs), which the FDA has been trying to stop. Make sure your dietary supplement products aren’t subject to excluded ingredients.
Since the Designer Anabolic Steroid Control Act of 2014, the vast majority of anabolic steroids and drug-like derivatives were made illegal to sell or possess, however, a handful of other active agents have taken their place, including SARMs, which are being marketed as performance-enhancing dietary supplements. Sometimes the compounds are listed as “Ostarine” on product labels though some have alternative names are may be undisclosed. Ingredients or products that claim “drug-like” effects may be too good to be true. However, many of these are actually unregulated drugs which haven’t been approved by the FDA for safety and effectiveness.
In terms of your company’s liability policy, it is paramount that manufacturers and retailers know specifically what ingredients are in the products that they produce and sell to the public. All insurance underwriters will have a list of ingredient exclusions, and which could leave you without protection from liability? when you most need it. Additionally, FDA enforcement is strict for selling unapproved substances which could lead to additional legal and financial complications.
If you have any questions about if your products are fully covered, reach out to your insurance broker to discuss your coverage and any ingredient exclusions that may affect your business. It may be possible to negotiate coverage and get an exclusion removed. We have several clients that didn’t realize that their previous coverage included exclusions that could have been easily removed.
I hope you found the following tips useful. Having appropriate coverage within the dietary supplements industry is crucial to protecting your reputation and business. For more information about common dietary supplement insurance issues, check out our resource page. If you have further questions, please feel free to reach out to me or Greg Doherty at the Bolton Dietary Supplement Group at 626.535.1459.
We will be attending Natural Products Expo West 2018 in Anaheim, CA on March 8th – 11th. Contact us to set up a meeting.