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In August, the FDA announced it was taking enforcement action against manufacturers and distributors of certain natural thyroid medications, raising questions from many practitioners about whether thyroid dietary supplements could be next.
Here’s what happened, and what it means for your practice and your patients.
The FDA sent warning letters to companies selling desiccated thyroid extract (DTE) medications. The FDA’s logic is straightforward: DTE products contain thyroid hormones such as T3 and T4, are explicitly marketed to treat hypothyroidism, and compete directly with FDA-approved alternatives (such as levothyroxine and liothyronine). Additionally, they have the potential for potency variability, which the FDA views as a patient safety risk.
All of those issues, combined with the fact that the FDA has never approved desiccated thyroid extract (DTE) medications, are the reason they’re being targeted for removal from the market.
Thyroid glandulars have been in use for centuries—dried and powdered in traditional Chinese medicine, and widely used in Western medicine beginning in the 1890s.
That history is important because the Dietary Supplement Health and Education Act of 1994 (DSHEA) created what is often called the grandfather rule: any dietary ingredient that was marketed in the U.S. before October 15, 1994, is legally recognized as a dietary ingredient and can continue to be sold without additional pre-market approval.
Thyroid supplements were marketed in the U.S. long before DSHEA’s 1994 cutoff. That long record of dietary and clinical use places thyroid glandulars squarely in the supplement category. The FDA’s legal argument hinges on the fact that DTE medications are drugs. That same argument doesn’t apply to thyroid supplements.
To answer that question, let’s look at another supplement that came under FDA scrutiny several years ago.
Red Yeast Rice, which has been used for centuries in Asia, was found in the 1970s to produce monacolin K, a compound identical to lovastatin, which is a cholesterol-lowering drug. In the 1990s, a product called Cholestin marketed standardized levels of monacolin K and made explicit cholesterol-lowering claims. FDA intervened to remove Cholestin from the market, classifying it as a drug.
Importantly, FDA never banned red yeast rice itself. Red Yeast Rice supplements remain widely available today, provided they aren’t marketed with drug-like claims or standardized to specific levels of monacolin K.
The same logic carries over to thyroid supplements. Just as the FDA left red yeast rice supplements on the market, it is unlikely the agency will target thyroid supplements. These products have a long history of safe use and are lawful dietary ingredients – so long as they aren’t marketed using inappropriate disease claims.
The FDA views this as a purely legal issue. From that perspective, like it or not, the FDA appears to be on solid ground with its arguments.
So, I believe there is a real risk of losing access to DTE drugs – unless/until they eventually go through FDA approval, which is costly and time-consuming. If you use these products with your patients, you might be wise to begin looking for alternatives.
Thyroid glandulars, by contrast, are established dietary ingredients with a long tradition of use. The precedent of red yeast rice reinforces the point: when marketed responsibly, supplements remain distinct from drugs and continue to be legally available.
At Professional Formulas, our commitment is clear. We maintain the highest quality standards, and we operate squarely within FDA and DSHEA regulations. You can count on us to protect your access to natural products that are safe and effective.
Mike Grubb
President & CEO
References
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These statements have not been evaluated by the Food and Drug Administration. No statement contained herein shall be construed as offering these products for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Homeopathic claims are based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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