FDA Regulation of Supplements and Herbal Remedies: A Call to Action

The House of Delegates has reaffirmed its interest in FDA regulation of supplements and herbal remedies in response to continued physician concern about their potential risks to patients. A growing number of patients are experimenting with these products, some of which offer true therapeutic benefits while others harm patients. The regulatory reality is that many of these products have not undergone FDA review, leading to "disingenuous" advertisements that can be confusing for consumers.

Key Takeaways:

• The House of Delegates has reaffirmed its intent to seek legislation to give the FDA legal authority over supplements and herbal remedies.
• The AMA and FDA should focus on regulating these products, rather than just the "bad actors" in the industry.
• The FDA already has authority to police against supplements that make false or unsubstantiated claims, but many delegates believe this authority is not being effectively exercised.
• Physicians need to be diligent in monitoring their patients' use of these substances, as some patients may be taking multiple supplements that interact with their medications.
• The AMA is calling for Congress to modify the Dietary Supplement Health and Education Act to require FDA safety and efficacy approval for supplements and herbal remedies.
• Patients are experimenting with a range of nutritional supplements and herbal remedies, with 16 deaths annually linked to dietary supplements, according to the National Nutritional Foods Assn.
• Prescription drugs kill about 106,000 people each year and injure another 2.1 million people.
• A patient being treated with a complex series of medications was found to be taking 25 different types of vitamin supplements.
• The FDA Deputy Commissioner, Michael Friedman, MD, stated that the agency already has authority to police against supplements that make false or unsubstantiated claims.

Statistics:

• 16 deaths annually linked to dietary supplements (National Nutritional Foods Assn)
• 106,000 deaths and 2.1 million injured annually due to prescription drugs
• 25 different types of vitamin supplements taken by a patient being treated with a complex series of medications

Sources:

• Chicago (newspaper article)
• National Nutritional Foods Assn (statement)
• Michael Q. Ford (NNFA Executive Director)
• Michael Friedman (FDA Deputy Commissioner)
• Judy Linger (MD, alternate delegate from the American Psychiatric Assn)
• American Medical Association (AMA) Annual Meeting proceedings