On March 2, the Government Accountability Office (GAO) released a report on dietary supplements, calling for the US Food and Drug Administration (FDA) to monitor supplements more closely and require increased adverse event reporting.
In December 2008, the FDA published its guidance regarding structure/function claims for dietary supplements in the form of non-binding recommendations to supplement industry manufacturers. Contrary to the oft-repeated notion that dietary supplements are unregulated, under the Dietary Supplement Health and Education Act of 1994, the “FDA has exclusive jurisdiction over the safety, and primary jurisdiction […]
The FDA invited comment about how to interpret Section 912, Provision 301 of the FDA Amendments Act of 2007.
At the web site of CA’s Office of Environmental Health Hazard Assessment (OEHHA), Prop 65 is described as the approval by CA voters in 1986 of an initiative to address their growing concerns about exposure to toxic chemicals.
Urgent Action Needed. The Time to Send Comments to the FDA is Now: comment period whether section 301 should be extended to include dietary supplements has been extended to November 25.
The National Animal Supplement Council (NASC) was formed in 2001 to deal with the regulation of animal feed as a drug.
The FDA is currently receiving comment about Section 912 of its Amendments Act (FDAAA), which deals with the regulation of foods containing substances that have undergone clinical trials; they have now extended that comment period until November 25. The Section 912 regulations could create a major shift in the divide between foods and drugs.
In 2006, AAHF took a stand against the proposed Dietary Supplement and Non-Prescription Drug Consumer Protection legislation, now law, because we felt the bill was not in the public’s best interest. The Food, Drug, and Cosmetic Act had already been amended to require reporting of serious adverse events for both over-the-counter and dietary supplements to […]
In recent issues, we have told you about Medicure Pharma’s so-called Citizens Petition to the FDA to ban any dietary supplements containing the natural and active form of vitamin B-6 called pyridoxal 5′-phosphate (P5P). A reader has asked: what is the difference between pyridoxine, the most common form of B-6, and P5P? Most supplements contain […]
Some of the natural substances taken through the FDA approval process don’t appear to be dangerous. For example, Omacor, the FDA approved fish oil, is only a problem because it is so expensive compared to regular fish oil. All of us who pay Medicare taxes are bearing this cost since Medicare won’t reimburse any other […]