AMA Steps Up Regulation of Dietary Supplements and Herbal Remedies

The American Medical Association (AMA) has intensified its scrutiny of dietary supplements and herbal remedies, citing concerns over patient safety and efficacy. The organization's House of Delegates has instructed the AMA to work with Congress to modify the Dietary Supplement Health and Education Act, requiring FDA approval for these products. This move follows a Supreme Court decision declining to hear a case challenging FDA labeling restrictions on dietary supplements. The AMA is also seeking to promote public awareness about the MedWatch program for reporting adverse events associated with alternative therapies.

Key Takeaways:

• The AMA will work with Congress to modify the Dietary Supplement Health and Education Act, requiring FDA approval for dietary supplements and herbal remedies for safety and efficacy.
• The organization will also advocate for oversight of existing products on the market, rather than grandfathering them in.
• Dr. Ronald Davis, past chair of the AMA Council on Scientific Affairs, expressed concerns over the congressional rationale for minimal restrictions on these products, stating, "It's high time to put these products under the authority of the FDA."
• Dr. Mathis L. Becker, of the Council on Legislation, emphasized the need for active and aggressive regulation, citing the AMA's goal of "knowing what people are talking about when it comes to these remedies."
• The AMA will work with the FDA to raise awareness about the MedWatch program for reporting adverse events associated with alternative therapies.
• The organization has also approved a report outlining ways physicians can educate patients about prescription drugs, including medication reviews and discussions about drug interactions and side effects.
• AMA Trustee Palma E. Formica, MD, emphasized the importance of physicians being aware of patients' other medications and supplements, stating, "Physicians should know when patients come in what other medications they are taking into their bodies."

Statistics:

• There are currently no specific statistics provided in the text on the number of existing products requiring oversight.
• The appeals court upheld the FDA's regulations, ruling that the labeling restrictions were "sufficiently narrowly tailored" to be deemed constitutional.
• The FDA has established standards for strength, quality, purity, packaging, and labeling for these products.
• There is no specific statistic on the number of adverse events reported through the MedWatch program.

Sources:

• American Medical Association. (no date)
• Supreme Court of the United States. (no date)
• FDA v. Food Store and the Nutritional Health Alliance, 2d Circuit Court of Appeals. (no date)