Are Supplements Regulated?

No doubt you have heard many reports about dietary supplements where the reporter asserts that supplements “are not regulated.”

This is blatantly false. Dietary supplements are indeed regulated by the US Food and Drug Administration. Dietary supplements are supplemental nutrition (or nutraceuticals) to one’s diet to ensure more optimal health of the individual.

While both dietary supplements and pharmaceuticals exist to address human health – the major distinctive difference is that dietary supplements are based on elements found in nature (minerals, plants, etc.) – while pharmaceuticals are synthesized compounds. In addition, legally, dietary supplements are defined as foods, they are taken orally to supplement the diet, while pharmaceuticals are legally known as substances that are intended to diagnose, treat or prevent disease. As an important related note: dietary supplements are legally meant to support the structure and function of an element in the body and are NOT allowed to be marketed to diagnose, treat or prevent disease (called “making a disease claim.”)

In 1994, Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) introduced the Dietary Supplement Health and Education Act (“DSHEA”), and it was signed into law on October 25, 1994 by President Bill Clinton.  Upon signing the law, he stated, “After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.”

The confusion about the supplement industry’s state of regulation boils down to another definition of how the FDA can act. Under DSHEA, supplement manufacturers don’t have to receive FDA approval before marketing dietary supplements that were marketed in the United States before 1994. Dietary ingredients that aren’t grandfathered are defined as New Dietary Ingredients (NDI). The suppliers of these NDI ingredients must provide reasonable evidence of their safety, or reasonable expectations of their safety to the FDA for review and approval prior to marketing.

In addition, under the Act, dietary supplements are indeed effectively regulated by the FDA for Good Manufacturing Practices – which all manufacturers must obtain –an arduous process but ensures safety via following numerous high standards of traceability and process operations. Obtaining GMP certification also constitutes a significant monetary investment. Because of these factors, DSHEA thwarts many shady companies that want to quickly cash in on supplement trends.

We at Herbsea are proud to provide you and your family with supplements that comply with DSHEA and GMPs.

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