Regulation

Senators ask FDA for national investigation of dietary supplements

Senate Democrats are calling on the Food and Drug Administration to do a nationwide investigation after four major retailers were accused of selling mislabeled and tainted dietary supplements in their New York stores. 

New York Attorney General Eric Schneiderman sent letters to GNC, Target, Wal-Mart and Walgreens on Monday asking them to immediately stop selling store brand herbal supplements in their New York locations. The products, which included echinacea, ginseng and St. John’s wort, allegedly failed to contain the labeled substance or contained ingredients not listed on the label.

“It is unconscionable that trusted retailers appear to be deliberately misleading their customers regarding the dietary supplements that they stock on their shelves and sell to consumers,” Sen. Dick Durbin (D-Ill.) said in a statement.

“Today, Sen. [Richard] Blumenthal [D-Conn.] and I are calling on the FDA to follow the lead of the New York Attorney General Eric Schneiderman and take steps to protect all American consumers from an industry shown to be selling products they know are at best, ineffective, and at worst, truly harmful.”

The senators have long advocated for stronger public protections against dietary supplements. 

In 2013, they introduced the Dietary Supplement Labeling Act to force manufacturers to register their products and ingredients with the FDA and to provide proof of any health benefit claims. 

“The apparent widespread sale of fraudulently-labeled dietary supplements by four major national retailers should be a major wake-up call that the industry is in desperate need of additional oversight,” Blumenthal said in a statement. “Americans spend billions of dollars a year on dietary supplements, and they deserve to know what they are buying.”

He went on to say that fake supplements containing cheap fillers and unidentified ingredients can be dangerous, even life threatening, to people with allergies.

The FDA requires companies to verify that their products are safe and properly labeled for their contents, but unlike drugs, supplements do not undergo the agency’s rigorous evaluation process, which scrutinizes everything about the drug — from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured, according to a release from the attorney general’s office.

Of the supplements tested in the New York investigation, only 21 percent contained the DNA of the plants listed on the products’ labels.

But the Council for Responsible Nutrition called the New York Attorney General’s actions a publicity stunt under the guise of protecting public health.

CRN President and CEO Steve Mister said botanical scientists have criticized the DNA barcoding technology used to test these drugs.

“Processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products,” he said.

Mister went on to criticize the attorney general for not giving the retailers an opportunity to respond to the allegations against.

“Responsible manufacturers and retailers take careful measures to ensure their consumers can purchase high-quality botanical supplements that contain what is on the label,” he said. “We stand by the safety and regulation of these products. We urge the New York State Attorney General to subject its own questionable testing methods to the same public scrutiny and peer review that he has called upon for our products.”