Regulatory Focus™ > News Articles > Group Asks FDA for More Warning Information on Dietary Supplement Labels

Group Asks FDA for More Warning Information on Dietary Supplement Labels

Posted 16 March 2015 | By Alexander Gaffney, RAC

Group Asks FDA for More Warning Information on Dietary Supplement Labels

A public health group is calling on the US Food and Drug Administration (FDA) change the warning labels on all herbal and dietary supplements to include more information about how the products might cause side effects, interact with pharmaceuticals and affect pregnant women.


The call, made in a new Citizen Petition by the group Pharmacists Planning Service (PPS), comes after a recent investigation by the New York Attorney General found that some dietary and herbal supplements did not contain the substances claimed on their labels. The substances included echinacea, ginseng and St. John's wort.

The dietary supplement industry, led by the Natural Products Association (NPA), has attacked the methodology behind the attorney general's findings, claiming they relied upon an ill-suited test known as DNA fingerprinting. The group claims that the extraction process used to create the supplements would have destroyed most DNA fragments in the supplements, meaning the tests would need to be able to determine if they contained authentic ingredients. Subsequent, industry-funded testing found the products to contain the labeled ingredients.

In their petition, PPS cites the NY attorney general's investigation, saying it is evidence the products may not be meeting "federal standards and good manufacturing procedures as outlined by the FDA."

"Over the past ten years, many tests done by the FDA and FTC [have] shown that herbal and dietary supplements did not contain any of the herbals listed on their labels, with many of these products being sold to consumers and patients," the group wrote. "These herbal and dietary supplements showed that the labeled medicinal herbs often contained cheap fillers such as powdered rice, asparagus and house plants, and in some cases substances that could be dangerous to those with allergies."

Other Problems

PPS also cited the sale of testosterone products in its petition, noting that while FDA recently warned marketers of prescription testosterone products that they needed to pare back the claims they make on their products, many dietary supplement products claiming to boost testosterone aren't subject to similar restrictions.

The group questioned why FDA would require these labeling restrictions on prescription pharmaceutical products and not on dietary supplements.

PPS also notes that many supplements can cause adverse reactions when taken with pharmaceutical products, including decreasing the efficacy of the pharmaceutical substance. "There are very few warnings with herbal and dietary supplements to consumers regarding these dangerous drug interactions," the petition notes.

Call for Action, but Little Authority to Act

Unfortunately for the petitioner, its suggested course of action may be well beyond the regulatory authority of FDA. PPS asks FDA to require supplement products to be labeled with warnings similar to those contained on over-the-counter drugs.

However, FDA's authority over dietary supplement labeling is limited under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which treats supplements more similarly to food products than drug products. As long as those products do not contain pharmaceutical ingredients and are not promoted using claims limited to drug products, FDA has little authority to regulate them as they would a prescription or over-the-counter pharmaceutical product.

PPS is not the first group to call for better adverse event labeling on supplements. In 2013, Sens. Dick Durbin and Richard Blumenthal introduced legislation that would require supplements to contain information about if an ingredient in the supplement is known to cause adverse events, drug interactions or risks to children or pregnant women. The bill was not approved.


PPS Citizen Petition

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