How are herbal supplements regulated?

How are herbal supplements regulated?

Myth: Herbal supplements are not regulated.

Truth: Herbal supplements are strictly regulated under the category of dietary supplements.

An herbal dietary supplement is defined through the US Food and Drug Administration’s Dietary Supplement Health and Education Act of 1994 as (paraphrased):

A product intended to supplement the diet that bears or contains an herb or other botanical, or a concentrate, constituent, extract or combination thereof. Among other specifics, the product is intended for internal consumption and is not a food or drug.

Dietary supplements are defined and codified by DSHEA, as the act is known, and the FDA requires that dietary supplement companies adhere to strict guidelines known as Current Good Manufacturing Practices (or cGMPs). These help ensure consumer safety with regulations around many aspects of production including (but not limited to): facilities and processes, hygiene and sanitation, training and documentation.

The FDA also works with the FTC (Federal Trade Commission) to ensure that any claims made about dietary supplements are truthful and not misleading. These regulations extend to labels, packaging and other marketing and advertising materials, including websites, social media content, emails and all messaging to consumers and retailers.