FDA The Los Angeles Times “Booster Shots” blog reports, “A new proposal to toughen the Food and Drug Administration’s power to regulate dietary supplements has the makers of vitamins, minerals and botanical extracts up in arms.”
However, “an editorial in the New England Journal of Medicine [NEJM] says the drug-safety agency’s proposed new powers do not go nearly far enough.”
The Times notes that the dietary supplements industry, which “produced and marketed 4,000 distinct products in 1994, when the regulatory framework for dietary supplements was written into law, now markets about 55,000 products to Americans who believe them to be safe to take.”
MedPage Today reports, “More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, ‘assuming they are both safe and effective,’ wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance” in the NEJM.
However, “they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote.”
The agency’s “‘guidance provides a thoughtful framework for evaluating the safety of new ingredients and if implemented it would lead to substantial improvement in safety,’ Cohen wrote, but he said he didn’t think the FDA goes far enough.”