Dietary Supplement Concerns Require Congressional Probe, Attorneys General Say
A group of 14 attorneys general are asking for Congress to become involved in the recent concerns over herbal supplements, following tests that suggest that many products sold by major retailers are not only fake, but could also pose a danger to public health.
A letter (PDF) was sent to the chairmen and ranking members of two U.S. Senate and House of Representatives subcommittees on April 2, calling for a congressional investigation of the herbal supplement industry and increased regulatory power by the FDA.
The request comes in the wake of an investigation by New York that discovered most of the herbal supplements sold under the store labels of Wal-Mart, Target, GNC and Walgreens do not contain the actual ingredients listed, and in some cases contained ingredients that could cause dangerous allergic reactions.
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“When consumers take an herbal supplement, they should be able to do so with full knowledge of what is in that product and confidence that every precaution was taken to ensure its authenticity and purity,” New York Attorney General Eric Schneiderman said in a press release. “I am proud to stand with a bipartisan group of attorneys general calling for a Congressional inquiry into whether stronger FDA oversight of the herbal supplements industry is needed. My office’s investigation reaffirmed long-standing concerns about the herbal supplements industry. The millions of consumers who take herbal supplements deserve to know whether they are getting what they pay for, and that these products are properly labeled and safe.”
The group that signed onto the letter include Schneiderman and attorneys general from Connecticut, D.C., Hawaii, Idaho, Indiana, Iowa, Kentucky, Massachusetts, Mississippi, New Hampshire, the Northern Mariana Islands, Pennsylvania and Rhode Island. The letter is addressed to Senators Jerry Moran and Richard Blumenthal, chairman and ranking member, respectively, of the Senate Subcommittee on Consumer Protection, Product Safety, Insurance, & Data Security; and Representatives Joe Pitts and Gene Green, chairman and ranking member, respectively, of the House Subcommittee on Health.
New York Investigation
The recent concerns regarding herbal supplement validity began after New York’s investigation. DNA testing revealed that 79% of the herbal supplements contained none of the primary ingredients. Schneiderman’s office conducted multiple DNA tests on the supplements to verify their ingredients.
The tests revealed that herbal supplement users who thought they were taking the products listed on the label were actually taking pills filled with rice, beans, asparagus, ground up houseplants, wheat and other items. For example, only four percent of herbal supplements tested at Wal-Mart actually contained the ingredients listed on the label, and 20 separate tests of GNC’s Herbal Plus Ginseng revealed that there was actually no ginseng present.
While most of the companies have removed the products from their shelves in New York, some still sell them in stores across the country and some have denied the charges. GNC recently reached an agreement with the New York Attorney General’s office after tightening its testing and verification process and is allowed to return its Herbal Plus brand to store shelves.
Herbal and dietary supplements are exempt from FDA oversight until a problem is detected, meaning that supplements on store shelves have not been tested by federal regulators for efficacy or safety. Some of the products tested contained wheat and other allergens that could be dangerous to consumers with certain allergies, but these ingredients were not listed on the products’ labels.
The letter notes that several members of congress have called on the FDA to investigate New York’s findings, fearing the problem may not be limited to New York.
“The FDA has long been aware of problems in the dietary and herbal supplement supply chain, from dubious ingredient sourcing to a failure to carry out proper testing on finished products,” the letter states. “In FY 2013, FDA inspectors cited two out of every three supplement manufacturers for allegedly violating current good manufacturing practices or ‘CGMPs.’ More than one in five of those citations — called Form 483s — observed that the manufacturer failed to verify that a finished supplements batch met product specifications as to identity, purity, strength, or composition.”
Herbal Supplement Lawsuits
Major retailers cited in the New York investigation face a growing number of class action lawsuits over their products. Wal-Mart currently faces at least five lawsuits over herbal supplements sold under its “Spring Valley Supplements” label. Walgreens faces at least 10 such claims over its “Finest Nutrition” supplements; GNC’s “Herbal Plus” label has generated six lawsuits and Target faces four claims over its “Up & Up” label.
Plaintiffs have called for all of the lawsuits to be consolidated as part of multidistrict litigations (MDLs), since each of the class action complaints present nearly identical cases asserting claims for violations of consumer protection statutes and deceptive business practices, seeking damages on behalf of all consumers who purchased the recalled herbal supplements.
Plaintiffs request that the cases be centralized before one judge to coordinate pretrial proceedings, reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the Courts.
The U.S. Judicial Panel on Multidistrict Litigation is not expected to hear oral arguments on the motions until at least May 28, at an upcoming hearing session scheduled in Minneapolis, Minnesota.
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