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 in an uproar. They are mad and upset at the new guidelines and believe that they are too strong. But other’s simply don’t agree. One editorial found in the New England Journal of Medicine says the drug-safety agency’s proposed new powers are not nearly strong enough.
Each year, Americans spend more than $28 billion on supplements assuming that they are both safe and effective. More than 100 million Americans consume vitamins, minerals, herbal ingredients, amino acids, and other naturally occurring products in the form of dietary supplements. By law, dietary supplements with established ingredients — ingredients that were sold in the United States before 1994 — may be marketed without any evidence of efficacy or safety.
But 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.
Therefore, unfortunately the law that was trying to prohibit this type of thing happening, has not been enforced, and things have gotten out of control. An industry that once produced and marketed a mere 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.
To rectify the situation, last July the FDA proposed new guidance designed to help it assess the new ingredients.
The proposed guidance clarifies the level of evidence the FDA would use to assess safety. Specifically, the safety of supplements would be evaluated according to three key factors: Documented history of use (e.g., in foods or in supplements or herbal medicines sold outside the United States), formulation and proposed daily dose (e.g., more or less than was formerly consumed), and the recommended duration of use (e.g., intermittent or long-term).
But, as stated, the industry is upset at the new guidelines. But, why wouldn’t they be? They have been getting away with breaking the law and making millions off of it. Bottom line is, these new guidelines will potentially hurt their bottom line. And, that’s why they are upset.
However, according to a New England Journal of Medicine “Perspective” article published this week by Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, even the current, ambiguous criterion has received lax FDA enforcement and has probably been ignored by industry.
Dr. Cohen feels the guidelines are insufficient. For instance, “historical use” of a product is too low to ensure safety, he said, wrote the LA Times. Also, noted Dr. Cohen, there is no mandate that supplement makers provide unfavorable safety data to the FDA as long as they provide studies showing the product is safe. As for products with no history of common use or marketed at mega doses, “not even single-dose tolerability studies in humans would be required” under the proposed rules, said Dr. Cohen who pointed out that “If the FDA succumbs to industry pressure, the public health consequences will be significant,” wrote the LA Times.