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. But an editorial in the New England Journal of Medicine says the drug-safety agency's proposed new powers do not go nearly far enough.
To expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use "novel" products -- minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in "mega-doses" much higher than have been customarily used in supplements. An industry that 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.
Since 1994, those selling "novel" products have been required to provide federal regulators with evidence supporting a product's "reasonable expectation of safety." In a New England Journal of Medicine "Perspective" article published this week, Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, suggests that even that vague standard has gone unenforced by the FDA and likely ignored by manufacturers eager to bring their supplements to market.