Beware: More Bullets in Russian Roulette Game With The FDA!

Beware: More Bullets in Russian Roulette Game With The FDA!

Often the dietary supplement landscape in the United States has been referred to as the “Wild, Wild West” with many companies taking the approach of “gunslinger,” thinking they can say anything on their label in terms of both marketing and health claims. Many companies have done due diligence to be compliant with FDA and FTC regulations. Others are playing Russian roulette with the FDA & FTC, stating unsubstantiated structure-function claims or even preventative claims (which are not allowed on U.S. labels for dietary supplements) with their advertising and marketing material.

Fortunately, the FDA is taking a more aggressive stance on this and sending warning letters, which can go as far as issuing a recall or stopping the sale of products. The FDA action doesn’t just target marketers of dietary supplements, it targets the manufacturers also. Inspection of dietary supplement manufacturers, packagers, labelers and storage facilities has shown some to be non-compliant. If non-compliance is observed these sites are issued an FDA Form 483. If a “483” is not responded to with corrective and preventative actions, warning letters will be issued.

The FDA is arming their “compliance gun” with more bullets so that fewer dietary supplements can get away with playing the game of Russian roulette. Some of these “bullets” include:

  • No prior notice to conduct site audits
  • Checking more dietary supplement labels to ensure that claims made are substantiated, not misleading, and are not preventative claims. Since products may be sold at retail locations or online, FDA agents are checking these outlets more frequently.

You DO NOT want to be playing games with the FDA. The damage goes beyond a recall. Public notices are sent out by the FDA on their official website and through various media outlets. With social media picking up these feeds, a company’s reputation could be permanently ruined and it could mean the end of business.

Quality Smart Solutions is your dietary supplements regulatory partner. Have us be your due diligence “eyes and ears” for your product packaging, labeling and marketing to ensure that you are FDA and FTC compliant.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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