New FDA regulations on supplements: What do they mean?

Recently, the U.S. Food and Drug Administration (FDA) released a new plan to improve regulation of dietary supplements – the first update in 25 years. In 1994, Congress passed the Dietary Supplement and Education Act (DSHEA), a bill that distinguished dietary supplements from prescription drugs in important ways.

Dietary supplements, in contrast to prescription drugs, cannot make claims to prevent, treat or cure a disease. For the most part, dietary supplements, including herbal medications and vitamins, were considered as “safe” under DSHEA unless proven otherwise.

The current dietary supplement market and number of consumers using supplements have grown exponentially since DSHEA was passed. The FDA is taking action to modernize and strengthen oversight of dietary supplements without compromising the work of DSHEA.

There are four main tenets of the new plan:

  • Improve communication with consumers about products deemed be a threat to health.
  • Develop a pathway for new dietary ingredients (NDI) to be reviewed.
  • Form a collaborative group of stakeholders from both public and private sectors – the Botanical Safety Consortium – to develop innovative methods of evaluating the safety of single ingredients and mixtures.
  • Continue enforcement of corrective/prohibitive actions against companies that are non-compliant with guidance standards.

The FDA has listed multiple priorities and steps that aim to achieve its goal of improving safety, integrity, and decision-making for all parties involved in producing and consuming dietary supplements. The primary goal of the FDA is to preserve consumer access to dietary supplements while protecting individuals from dangerous and unlawful products.

As the FDA moves to make these changes within the industry, we as consumers should stay informed and move to continue these advancements for the safety of all. More detailed information will be released in the coming months as the FDA continues to develop these plans.

For more information and specific details about initiatives, please visit the FDA website.

First-year Pharmacy resident Brian Norman, PharmD, authored this blog post, with clinical oversight from Lucy Crosby, PharmD, drug information pharmacy specialist with Prisma Health’s Upstate Pharmacy.

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