In recent years, increased consumer interest in improving overall health and well-being has been a key driver behind the growth in the dietary supplement industry. With promises ranging from better sleep to reduced stress and improved memory, opportunities are ripe for the picking for businesses looking to expand into the supplement market. However, increased opportunities come with risks – and businesses must be aware of the strict regulatory demands placed on the dietary supplement industry by the Food and Drug Administration (FDA). 

The FDA defines dietary supplements as additives used to supplement one’s diet. It states that nutritional dietary supplements, even if labeled as such, are considered a drug — meaning the FDA must impose strict regulations.

The FDA shares, “In general, even if a product is labeled as a dietary supplement, a product intended to treat, prevent, cure, or alleviate the symptoms of a disease is a drug, and subject to all requirements that apply to drugs.”

Further, under current law, the FDA:

  • Does not have authority to approve the safety and effectiveness of supplements, or to approve a company’s labeling of a product before being sold to the consumer. 
  • Is not responsible for ensuring that a company’s product meets FDA safety standards not otherwise in violation of the law. This responsibility and liability lie on the shoulders of the company.  
  • Requires that all supplements must include nutrition information in the form of a “Supplement Facts” information label that includes:
    • The suggested number of servings per container
    • The amount per serving and list of ingredients
    • A statement on the packaging that clearly identifies the product as a dietary supplement
Surprisingly, dietary supplements are not required to go through clinical trials prior to being sold to consumers. To regulate these products for effectiveness, safety and quality, the FDA: 

  • Audits manufacturing facilities to ensure they are following manufacturing best practices established and set forth by the FDA.
  • Monitors adverse reports and other product complaints by consumers, health care professionals and even other companies that produce dietary and nutritional supplements. 
  • Reviews the status of new ingredients being brought into the market, confirming them as having “generally recognized as safe” status or as containing newly approved dietary ingredients. 

As a retail broker, it is important to stay informed on the ever-changing and highly regulated supplement industry. By doing so, you can help your clients better understand what they may be up against and secure the right insurance to mitigate potential risks.