An editorial in the New England Journal of Medicine argues that an FDA proposal to improve safety of dietary supplements does not go far enough. The proposed regulation would require dietary supplement manufacturers to submit safety data before they can legally sell their products.
By law (the Dietary Supplement Health and Education Act of 1994 (DSHEA)) dietary supplements that contain established ingredients can be sold in the U.S. without submitting and pre-market safety information to the FDA or proving that are effective.
Any ingredient that was not sold before 1994 is considered a new ingredient. After 1994, manufacturers of new ingredients in dietary supplements must submit data to the FDA supporting a “reasonable expectation of safety.”
Unfortunately, the FDA has had a very hard time enforcing this requirement:
- Since DSHEA passed in 1994, the number of dietary supplements has increased from 4,000 to 55,000. Yet although there are more than 50,000 new products, the FDA has received only 170 notifications of “new ingredients” since 1994 — potentially, thousands of dietary supplements are being sold in the U.S. without undergoing even preliminary safety testing of “new ingredients”
In the 18 years since DSHEA passed, it is unlikely that there have actually been just 170 new ingredients.
In response to this situation, in July 2011, the FDA has proposed new guidelines that would clarify what constitutes a “new ingredient” and what safety information manufacturers would be required to submit.
The proposed changes would clarify the level of evidence that a manufacturer of dietary supplements would need to submit to the FDA so the agency could determine whether the supplement is safe. Safety would be evaluated based on three factors:
- Documented history of use (if the ingredient has a long history of use in foods, supplements, or herbal medicine)
- Formulation and proposed daily dose (if the proposed dose exceeds historical ingestion rates, the FDA would require safety testing)
- Recommended duration of use
Dr. Pieter Cohen argues that the FDA’s proposed guidelines are inadequate.
The easiest way a manufacturer could avoid expensive clinical studies is to claim that the product has a “documented history of use.”
Sometimes, dietary supplement manufacturers claim that their products are safe because the ingredients have a “history of use,” but the actual product formulates the ingredient in a new way. For example, sometimes manufacturers make a synthetic replica of a botanical compound and then claim that their product is “herbal.” For example, DMAA, a synthetic chemical that was labeled as “geranium extract,” sold as a dietary supplement, and linked to heart attacks and several deaths.
Instead of conducting clinical trials, manufacturers can use historical data to claim a supplement is safe. Cohen argues that simply because an ingredient has been used in the past does not necessarily guarantee its long-term safety, and scientific studies should be required instead. Under the guidelines, not even a single-dose tolerability study would be required to introduce a new ingredient.
Furthermore, even if the manufacturers conduct safety studies, the FDA guidelines do not require a manufacturer to submit all safety data. The manufacturer could cherry-pick study information that favors its product.
Even so, dietary supplement industry advocates say that the FDA’s proposed guidelines go too far in their regulation. They say that requiring scientific evidence of safety undermines DSHEA, which grants dietary supplements exceptional status. The safety requirement of a dietary supplement is far lower than for food additives. The industry advocates say the new regulations violate this law by elevating the status to the level of food additives. Cohen argues that the industry’s argument is invalid, because the FDA has an established legal authority over new ingredients that is higher than its authority over established ingredients.
More than 100 million people in the U.S. spend $28 billion on “dietary supplements” — products that include vitamins, minerals, herbal ingredients, and other products. They assume that they are both safe and effective. In reality, according to Cohen, they cannot be assured that products are safe because the FDA’s regulations are too weak.
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