Herbal Supplements, their Safety and Marketing: State Prosecutors to Form Coalition

The states are getting their respective acts together. This report today:

 A group of attorneys general is expected to announce on Tuesday that they are forming a coalition to crack down on fraud and quality control issues in the herbal supplement industry.

The coalition would signal a shift in the way law enforcement agencies ensure the safety of herbal supplements, a $5 billion-a-year industry that has been plagued by complaints of mislabeling. An investigation by the New York State attorney general’s office led to accusations last month that four national retailers were selling supplements that contained either little or none of the medicinal herbs advertised on their labels or, in many cases, included cheap fillers and contaminants like powdered rice, wheat and houseplants.

The retailers — GNC, Target, Walmart and Walgreens — were forced to pull the products from their shelves. The state attorney general, Eric T. Schneiderman, later issued subpoenas to the manufacturers of the products, demanding that they explain how they verify the quality of their products and what testing they do to support a variety of claims on their labels, like “gluten free” and “hypoallergenic.”

Critics of the industry have argued that the Food and Drug Administration does not have enough power to keep fraudulent or dangerous products from reaching store shelves. The F.D.A. is restricted by a 1994 federal law — sponsored by Senator Orrin G. Hatch, Republican of Utah, who has strong financial ties to the industry — that prevents it from subjecting supplements to the strict approval process applied to prescription drugs.

As a result, unsafe herbal products generally are pulled from stores only after they have caused harm. But Dr. Arthur P. Grollman, an expert on herbal supplements at Stony Brook University, said he believed that greater action at the state level might pressure the supplement industry to address some of its safety issues.

Dr. Grollman was among the experts who more than a decade ago led calls for a ban on ephedra, an herbal supplement that was linked to many heart attacks, strokes and deaths. The F.D.A. eventually banned ephedra in 2004, only after several states and counties had introduced legislation outlawing its sale in their local stores.

http://well.blogs.nytimes.com/2015/03/09/safety-of-herbal-supplements-pulls-prosecutors-together/?_r=0

New York AG asks Retailers to Halt Sales (GNC, Target, Walgreens), Round 2

Round 2 continues, as a number of companies have received letters. These include Pharmavite (the Nature Made brand); NBTV - which makes Sundown Naturals, Nature's Bounty, Met-Rx and Solgar. Also named were Nature's Way, and Nutraceuticals Corp.  

Previously, these companies were sent letters: 

 GNC:

• Six “Herbal Plus” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from four locations with representative stores in Binghamton, Harlem, Plattsburgh & Suffolk.
• Only one supplement consistently tested for its labeled contents: Garlic. One bottle of Saw Palmetto tested positive for containing DNA from the saw palmetto plant, while three others did not. The remaining four supplement types yielded mixed results, but none revealed DNA from the labeled herb.
• Of 120 DNA tests run on 24 bottles of the herbal products purchased, DNA matched label identification 22% of the time.
• Contaminants identified included asparagus, rice, primrose, alfalfa/clover, spruce, ranuncula, houseplant, allium, legume, saw palmetto, and Echinacea.

Target:

• Six “Up & Up” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Valerian Root, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Nassau County, Poughkeepsie, and Syracuse.
• Three supplements showed nearly consistent presence of the labeled contents: Echinacea (with one sample identifying rice), Garlic, and Saw Palmetto. The remaining three supplements did not revealed DNA from the labeled herb.
• Of 90 DNA tests run on 18 bottles of the herbal products purchased, DNA matched label identification 41% of the time.
• Contaminants identified included allium, French bean, asparagus, pea, wild carrot and saw palmetto.

Walgreens:

• Six “Finest Nutrition” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three locations with representative stores in Brooklyn, Rochester and Watertown.
• Only one supplement consistently tested for its labeled contents: Saw Palmetto. The remaining five supplements yielded mixed results, with one sample of garlic showing appropriate DNA. The other bottles yielded no DNA from the labeled herb.
• Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 18% of the time.
• Contaminants identified included allium, rice, wheat, palm, daisy, and dracaena (houseplant).

Walmart:

• Six “Spring Valley” brand herbal supplements per store were purchased and analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw Palmetto. Purchased from three geographic locations with representative stores in Buffalo, Utica and Westchester.
• None of the supplements tested consistently revealed DNA from the labeled herb. One bottle of garlic had a minimal showing of garlic DNA, as did one bottle of Saw Palmetto. All remaining bottles failed to produce DNA verifying the labeled herb.
• Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched label representation 4% of the time.
• Contaminants identified included allium, pine, wheat/grass, rice mustard, citrus, dracaena (houseplant), and cassava (tropical tree root).

The Attorney General’s investigation follows an important study conducted by the University of Guelph in 2013 that also found contamination and substitution in herbal products in most of the products tested. As was said at the time by a spokesperson for the University of Guelph, “The industry suffers from unethical activities by some manufacturers.”

The market for herbal supplements is significant. The Natural Products Foundation estimates that the dietary supplement industry contributes $61 billion dollars to the national economy. A 2013 study from the Canadian Institutes of Health Research estimated there are about 65,000 dietary supplements on the market consumed by more than 150 million Americans.

That same study also found that more than half of Food and Drug Administration (FDA) Class I drug recalls between 2004 and 2012 were dietary supplements. Class I recalls are reserved for drugs or supplements for which there is a “reasonable probability that [their use] will cause serious adverse health consequences or death.”

The Attorney General thanks Dr. James A. Schulte II of Clarkson University in Potsdam, N.Y. for providing his expertise in DNA barcode testing for this investigation.

The case is being handled by Executive Deputy Attorney General Marty Mack and Assistant Attorney General Deanna Nelson with the assistance of NYAG’s thirteen regional offices.