An investigation of herbal supplements by the New York State attorney general's office carries a sobering message for the rest of the nation as well.
The New York Times reports that the investigation looked at the store brands of well-known herbal products sold by four prominent national retailers: GNC, Target, Walgreens and Walmart. Among the popular products examined were ginkgo biloba, St. John’s wort and ginseng pills. Four out of five of the products tested did not include any of the herbs listed on their labels. Even worse, hidden ingredients and contaminants could be dangerous to people with allergies to those substances. That such well-known brands should be found to be fraudulent suggests that the problem infects the entire industry.
The attorney general has sent the four retailers cease-and-desist letters and demanded that they explain their procedures for verifying the ingredients in their supplements. All four stopped selling the challenged products in New York and pledged to give the investigators the information requested. Walgreens and Target pulled the products from their stores nationwide. But Walmart and GNC are continuing to sell their products in stores outside New York.
GNC, a vitamin and supplements chain, claimed that the testing methodology – known as DNA-bar-coding technology – is of "doubtful validity" for assessing herbal products.
The report says that seems unlikely given that the tests were carried out by an expert on DNA bar-coding, James Schulte II, an associate professor of biology at Clarkson University in Potsdam, New York and Beckman Coulter Genomics, a Massachusetts company that is expert in DNA bar-coding. The attorney general's office has compiled a list of more than 70 scientific papers showing that DNA bar-coding was able to identify ingredients.
The industry contends that the testing methods it uses are more accurate and meet the standards of the United States Pharmacopeial Convention, a non-profit scientific organisation that sets standards for ingredients used in dietary supplements, but this investigation may well prove that claim hollow.
The report says consumers need to be aware that herbal or other supplements that claim to improve health are not subject to the same strict standards for safety and efficacy that the US Food and Drug Administration applies to prescription drugs. The supplement industry's backers in Congress and state capitals have long protected it from stricter regulation. New York's investigation ought to persuade legislators that stronger oversight is needed.
This is 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. But, reports The Washington Post, none of that has changed the fact that Americans are nuts for dietary supplements
Sales in 2013 reached $13bn, 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.
When researchers take a closer look at the products, the results can be alarming. Researchers from a 2012 Inspector General's report found that 20% 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.
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.
The report says 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 hospitalisation 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 centres instead of the FDA.
SA health and beauty retailer Clicks is, meanwhile standing by the integrity of US-based GNC supplements, for which it holds the exclusive distribution rights in SA. Business Day reports that 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.
Clicks launched GNC in SA last March, and now sells its products in 165 stores. GNC 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-bar-coding 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," Kristafor said. 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.
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". 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.
[link url="http://www.nytimes.com/2015/02/07/opinion/herbal-supplements-without-herbs.html?emc=edit_th_20150207&nl=todaysheadlines&nlid=60640071&_r=0"]Full report in The New York Times[/link]
[link url="http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/"]Further report in The New York Times[/link]
[link url="http://www.nytimes.com/interactive/2015/02/02/health/herbal_supplement_letters.html"]Cease-and-desist letters sent to the retailers[/link]
[link url="http://www.washingtonpost.com/blogs/wonkblog/wp/2015/02/04/americans-are-ignoring-the-science-and-spending-billions-on-dietary-supplements/?utm_source=nextdraft&utm_medium=email"]Full report in The Washington Post[/link]
[link url="https://oig.hhs.gov/oei/reports/oei-01-11-00210.asp"]Inspector General’s report[/link]
[link url="http://archinte.jamanetwork.com/article.aspx?articleid=1678813#Results"]JAMA Internal Medicine abstract[/link]
[link url="http://jama.jamanetwork.com/article.aspx?articleid=1917421"]JAMA article summary[/link]
[link url="http://www.bdlive.co.za/business/retail/2015/02/05/clicks-stands-by-its-herbal-products-despite-us-findings"]Full Business Day report[/link]
[link url="http://well.blogs.nytimes.com/2015/02/03/sidebar-whats-in-those-supplements/"]The New York Times: What's in those supplements?[/link]
[link url="http://www.nytimes.com/interactive/2015/02/02/health/herbal_supplement_letters.html"]NYC AG's 'cease and desist' letters[/link]
[link url="http://www.ag.ny.gov/press-release/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests"]US AG's statement[/link]