Clicks/GNC in the poo?

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Posted 06 February 2015

Clicks launched the supplement range, GNC, in SA last March AFTER new CAM regulations were published, regulations which in essence made these products illegal. Makes you wonder about the scruples and ethics of the company and its directors.

On Monday, 2nd February 2015, New York attorney-general Eric Schneiderman ordered GNC, Walmart, Target and Walgreens to stop selling some of their brands after tests found only one in five products contained the herbs on their labels, and that most of them contained cheap fillers such as powdered rice.

Of course, GNC (and Clicks), stand by this range of products: ““GNC stands by the efficacy of its products. It has removed them in New York but not elsewhere,” Mr Kristafor said at Clicks’ head office in Woodstock.”

One vital aspect not addressed by anyone is this simple facts: there is little to no evidence to back up ANY claims being made for these products. In other words, even if the products DID contain the active ingredients, the possibility of the claims being valid would be no more likely than if it did not contain the active ingredients. In other words, does the product work! Unlikely. Certainly not supported by evidence.

Clicks stands by its herbal products despite US findings

by Tamar Kahn, 05 February 2015, 05:43

http://www.bdlive.co.za/business/retail/2015/02/05/clicks-stands-by-its-herbal-products-despite-us-findings

HEALTH and beauty retailer Clicks on Wednesday stood by the integrity of US-based GNC supplements, for which it holds the exclusive distribution rights in SA.

The company said it would continue to sell GNC herbal products despite a finding by the New York attorney-general’s office that GNC was selling fraudulent and potentially dangerous products.

The development casts the spotlight on the safety and efficacy of herbal supplements, which are not subject to the same regulatory oversight as pharmaceuticals.

On Monday, New York attorney-general Eric Schneiderman ordered GNC, Walmart, Target and Walgreens to stop selling some of their brands after tests found only one in five products contained the herbs on their labels, and that most of them contained cheap fillers such as powdered rice. Some of the products also contained allergens.

“The investigation makes one thing abundantly clear: the old adage ‘buyer beware’ may be especially true for consumers of herbal supplements,” Mr Schneiderman said in a statement.

Clicks launched GNC in SA last March, and now sells its products in 165 stores. On Wednesday, GM Sean Kristafor said GNC disputed the New York attorney-general’s findings, which he said were based on inappropriate tests.

“The Council for Responsible Nutrition says DNA-barcoding technology is not the correct test, and we were not given an opportunity to review the results.

“GNC stands by the efficacy of its products. It has removed them in New York but not elsewhere,” Mr Kristafor said at Clicks’ head office in Woodstock.

He said GNC tested all its products with methods approved by governing bodies such as the US Pharmacopeia and British Pharmacopeia. The methods the US attorney-general used to test its products had not been approved by these bodies, he said.

Mr Kristafor said Clicks did not conduct its own tests on the products it imported from GNC’s distribution centre in Greenville, South Carolina, but paid a consultancy to review the products’ “quality certificates”.

US authorities tested six different “herbal plus” products bought from four GNC retailers in New York state: Gingko biloba, St John’s Wort, Ginseng, Garlic, Echinacea and Saw Palmetto. Of the 24 bottles assessed, only the garlic product tested consistently for its labelled contents, and only one bottle of the saw palmetto did.

None of the remaining products yielded DNA from the herb on the label, and there were a host of contaminants including rice, alfalfa, spruce and legumes.

Medicines Control Council registrar Joey Gouws said she would ask local inspectors to look into the issue, and that she would comment at a later stage.

Here are three articles in New York Attorney General Eric Schneiderman’s actions against 4 major retailers – copied from the Washington Post and The Hill, as “fair use”.

Americans are ignoring the science and spending billions on dietary supplements

By Jason Millman February 4 at 4:29 PM

http://www.washingtonpost.com/blogs/wonkblog/wp/2015/02/04/americans-are-ignoring-the-science-and-spending-billions-on-dietary-supplements/

Dietary supplement fans got a big “buyer beware” warning this week when the New York attorney general’s office ordered GNC, Target, Walgreens and Wal-Mart to pull a number of store-brand products from their shelves, following an investigation that found most didn’t contain herbs listed on their labels. In some cases, the attorney general said the supplements didn’t even identify potentially dangerous allergens.

It was the latest in a series of studies and investigations that have cast serious doubt on the safety and reliability of these products, which face laxer regulatory scrutiny compared to prescription drugs. None of that has changed the fact, though, that Americans are nuts for dietary supplements, as you can see in the chart below (red bars indicate projected sales).

Sales in 2013 reached $13 billion, as more people turn to the supplements to boost their health and lose weight. One of their biggest boosters is syndicated TV host Mehmet Oz of “Dr. Oz” fame, even though “America’s doctor,” as he’s also known, has gotten into trouble for pushing pills with little medical grounding.

There’s a common public misperception that these products face the same rigorous oversight that pharmaceuticals receive from the FDA. They don’t, thanks to a federal law that’s been in place since 1994. Manufacturers of dietary supplements are required to attest their products are safe and accurately tested, but unlike prescription drugs, they’re not tested by the FDA before they go to market. A 2012 report from the Inspector General’s office recommended that the FDA seek out this authority through legislation and to expand its limited surveillance of products once they’re available to consumers.

Researchers from the same Inspector General’s report found that 20 percent of the weight loss and immune system support supplements they purchased made illegal claims about their ability to treat and cure disease. A year later, Harvard researchers found that between 2004 and 2012, there were 237 recalls of dietary supplements — accounting for more than half of FDA recalls of Class 1 drugs, which mean the products contain substances that can cause death or serious health problems. And in October, a JAMA study found most of supplements that were recalled for containing dangerous banned drugs were still available to consumers at least six months later.

The Council for Responsible Nutrition, a trade group representing dietary supplement manufacturers, often pushes back against these studies as misrepresentations of the industry. For example, they said the latest JAMA study proved that the vast majority of recalled items were successfully removed from the market. And the group slammed the New York attorney general’s investigation as a “self-serving publicity stunt under the guise of public health,” contending that his office’s findings relied on flawed science.

Federal oversight of the industry has tightened—somewhat. Since 2007, manufacturers have been required to report anytime a consumer experiences a serious medical reaction (whether it’s hospitalization or even death) to the FDA within 15 days. The agency received more than 6,000 reports between 2008 and 2011, according to a March 2013 Government Accountability Office report, with most of those coming from industry. However, the GAO said it believes these are probably under-reported because some consumers appear to report these events to poison control centers instead of the FDA.

Senators ask FDA for national investigation of dietary supplements

By Lydia Wheeler – 02/04/15 12:14 PM EST

http://thehill.com/regulation/231716-senators-call-on-fda-to-investigate-mislabeled-herbal-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.”

 

New York Attorney General Targets Supplements at Major Retailers

By Anahad O’Connor February 3, 2015 12:00 am February 3, 2015 12:00 am

http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?ref=health&_r=0#

New York State attorney general’s office accused four major retailers on Monday of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves.

The authorities said they had conducted tests on top-selling store brands of herbal supplements at four national retailers – GNC, Target, Walgreens and Walmart – and found that four out of five of the products did not contain any of the herbs on their labels. The tests showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.

The investigation came as a welcome surprise to health experts who have long complained about the quality and safety of dietary supplements, which are exempt from the strict regulatory oversight applied to prescription drugs.

The Food and Drug Administration has targeted individual supplements found to contain dangerous ingredients. But the announcement Monday was the first time that a law enforcement agency had threatened the biggest retail and drugstore chains with legal action for selling what it said were deliberately misleading herbal products.

Among the attorney general’s findings was a popular store brand of ginseng pills at Walgreens, promoted for “physical endurance and vitality,” that contained only powdered garlic and rice. At Walmart, the authorities found that its ginkgo biloba, a Chinese plant promoted as a memory enhancer, contained little more than powdered radish, houseplants and wheat – despite a claim on the label that the product was wheat- and gluten-free.

Three out of six herbal products at Target – ginkgo biloba, St. John’s wort and valerian root, a sleep aid – tested negative for the herbs on their labels. But they did contain powdered rice, beans, peas and wild carrots. And at GNC, the agency said, it found pills with unlisted ingredients used as fillers, like powdered legumes, the class of plants that includes peanuts and soybeans, a hazard for people with allergies.

The attorney general sent the four retailers cease-and-desist letters on Monday and demanded that they explain what procedures they use to verify the ingredients in their supplements.

“Mislabeling, contamination and false advertising are illegal,” said Eric T. Schneiderman, the state attorney general. “They also pose unacceptable risks to New York families – especially those with allergies to hidden ingredients.”

The attorney general’s investigation was prompted by an article in the New York Times in 2013 that raised questions about widespread labeling fraud in the supplement industry. The article referred to research at the University of Guelph in Canada that found that as many as a third of herbal supplements tested did not contain the plants listed on their labels – only cheap fillers instead.

Industry representatives have argued that any problems are caused by a handful of companies on the fringe of the industry. But New York’s investigation specifically targeted store brands at the nation’s drugstore and retail giants, which suggests that the problems are widespread.

“If this data is accurate, then it is an unbelievably devastating indictment of the industry,” said Dr. Pieter Cohen, an assistant professor at Harvard Medical School and an expert on supplement safety. “We’re talking about products at mainstream retailers like Walmart and Walgreens that are expected to be the absolute highest quality.”

In response to the findings, Walgreens said it would remove the products from its shelves nationwide, even though only New York State had demanded it. Walmart said it would reach out to the suppliers of its supplements “and take appropriate action.”

A spokeswoman for GNC said that the company would cooperate with the attorney general “in all appropriate ways,” but that it stood behind the quality and purity of its store brand supplements. The company said it tested all of its products “using validated and widely used testing methods.”

Target did not respond to requests for comment.

The F.D.A. requires that companies verify that every supplement they manufacture is safe and accurately labeled. But the system essentially operates on the honor code.

Under a 1994 federal law, supplements are exempt from the F.D.A.’s strict approval process for prescription drugs, which requires reviews of a product’s safety and effectiveness before it goes to market.

The law’s sponsor and chief architect, Senator Orrin G. Hatch, Republican of Utah, is a steadfast supporter of supplements. He has accepted hundreds of thousands of dollars in campaign contributions from the industry and repeatedly intervened in Washington to quash proposed legislation that would toughen the rules.

Mr. Hatch led a successful fight against a proposed amendment in 2012 that would have required supplement makers to register their products with the F.D.A. and provide details about their ingredients. Speaking on the floor of the Senate at the time, Mr. Hatch said the amendment was based on “a misguided presumption that the current regulatory framework for dietary supplements is flawed.”

Critics say it is all too easy for dangerous supplements to reach the market because they are not subject to a review or approval process. Under current law, supplements are assumed to be safe until the authorities can prove otherwise. And in general, they are pulled from shelves only after serious injuries occur – which is not uncommon.

In 2013, for example, an outbreak of hepatitis that struck at least 72 people in 16 states was traced to a tainted supplement. Three people required liver transplants, and one woman died.

It is not only consumers. Hospitals have been affected, too. In December, an infant at a Connecticut hospital died when doctors gave the child a popular probiotic supplement that was later found to be contaminated with yeast. After the child’s death, the F.D.A. issued a warning to the public that reiterated its limited control over supplements.

“These products are not subject to F.D.A.’s premarket review or approval requirements for safety and effectiveness,” the F.D.A. stated, “nor to the agency’s rigorous manufacturing and testing standards for drugs.”

As part of its investigation, the attorney general’s office bought 78 bottles of the leading brands of herbal supplements from a dozen Walmart, Target, Walgreens and GNC locations across New York State. Then the agency analyzed the products using DNA bar coding, a type of genetic fingerprinting that the agency has used to root out labeling fraud in the seafood industry.

The technology allows scientists to identify plants and animals by looking for short sequences of DNA unique to each organism, which can then be quickly analyzed – much like the bar codes on grocery items – and compared with others in an electronic database. The technology can single out which plants a supplement contains by identifying its unique DNA.

Dr. Cohen at Harvard said that the attorney general’s test results were so extreme that he found them hard to accept. He said it was possible that the tests had failed to detect some plants even when they were present because the manufacturing process had destroyed their DNA.

But that does not explain why the tests found so many supplements with no DNA from the herbs on their labels but plenty of DNA from unlisted ingredients, said Marty Mack, an executive deputy attorney general in New York. “The absence of DNA does not explain the high percentage of contaminants found in these products,” he said. “The burden is now with the industry to prove what is in these supplements.”

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