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Herbal Supplements: A Massive Industry with Little Oversight

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Washington, DCSeemingly lost in the headlines over the New York State attorney general’s assertion that four major retailers have been selling fraudulent herbal supplements, instantly triggering a host of lawsuits and questions over testing methods, is the fact that the US Food and Drug Administration (FDA) has not updated its definition of “natural” since 1994. What’s more, a prominent Republican Senator who has reportedly accepted campaign contributions in the hundreds of thousands of dollars from the supplement industry has consistently lobbied in Washington to stonewall legislation that would toughen the rules.

Barely six weeks have gone by since the Office of the New York State Attorney General issued a statement following the testing of various brands of herbal supplements sold by four major retailers: GNC, Target, Walgreens and Walmart. According to the New York Times (2/3/15), an investigation found that four out of five of the products tested failed to contain any of the herbs advertised or stated as such on product labeling. Testing found the supplements in question contained little more than cheap and inexpensive fillers such as asparagus, powdered rice and extracts from various house plants.

In some cases, according to the tests, the products contained powdered legumes, a class of plant that encompasses peanuts and soybeans. Those ingredients are alleged as not reflected at all on the product labeling. Any consumer with a peanut allergy, in theory, could suffer grave health effects from consuming a legume extract without knowing.

“Mislabeling, contamination and false advertising are illegal,” said Eric T. Schneiderman, New York State’s attorney general, in a statement appearing in the New York Times. “They also pose unacceptable risks to New York families - especially those with allergies to hidden ingredients.”

The concern was reflected by learned professionals who closely follow the hugely popular supplement industry. “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.”

But is the data correct? There are doubts, now, about the testing methods. Dr. Cohen, in the same breath, noted in the New York Times article that test results provided by the state’s Attorney General’s office were so extreme, that he found them somewhat hard to accept.

Critics of the testing method(s) used note a concern that testing can destroy the unique DNA of the plants and extracts contained in the supplements. That may be true, and yet according to an executive deputy in the New York State Attorney General’s office, “the absence of DNA does not explain the high percentage of contaminants found in these products,” said Marty Mack, in comments to the New York Times. “The burden is now with the industry to prove what is in these supplements.”

Not surprisingly, lawsuits have followed

Meanwhile, lawsuits have been quick to follow - the first proposed class action filed within just a couple of days of the Attorney General’s release. That’s little surprise, given the size and scope of the herbal supplement industry, which is projected to reach $115 billion by 2020. This, according to a report released in January by Global Industry Analysts Inc. There have since been more than 50 lawsuits proposed in the weeks since the story broke. Plaintiff’s lawyers have asked the US Judicial Panel on Multidistrict Litigation to coordinate the cases before a single judge, advocating for several courts in Arkansas, California, Florida, Illinois, Ohio and Kentucky. The panel is expected to take up the matter at its May 28th hearing in Minneapolis.

It’s no surprise that trade associations and other industry reps have weighed in to discredit the DNA Bar Code testing methods used. That debate continues - as does an ongoing debate about whether or not it’s time for the FDA to acquire more teeth in the oversight of such a large, billion-dollar industry. Supplements are exempt from the kind of strict approvals process long reserved for pharmaceutical drugs - and that’s been the case since 1994. Critics are suggesting that it’s time to provide the FDA with the power to tighten controls.

Advocates of tighter oversight point to the 2013 hepatitis outbreak that affected 72 individuals in 16 states. Three people required liver transplants and one woman died. That outbreak was traced to a tainted herbal supplement.

Just this past December, an infant at a hospital in Connecticut died when doctors gave the child what was described as a popular probiotic that was later found to be contaminated with yeast.

Following the child’s death, the FDA issued a statement: “These products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness,” the FDA stated, “nor to the agency’s rigorous manufacturing and testing standards for drugs.”

Will there be further attempts to increase oversight?

But will that change? While the debate swirls over the New York State Attorney General’s investigation, together with mounting lawsuits and the testing methods used, one is left to wonder about a potential pushback toward the idea of strengthened oversight of the herbal supplement industry. As noted in the New York Times report, Senator Orrin Hatch (R-Utah) was sponsor and chief architect of the original 1994 federal law that allows the exemption of supplements from rigorous testing. In this way, supplements are assumed safe, unless they are proven otherwise.

Hatch, who is identified by the New York Times as remaining a steadfast supporter of supplements and, as has been reported, having received campaign contributions from the supplement industry, has a record of intervening whenever there is an attempt to provide the FDA with more oversight on supplements. The latest attempt was three years ago when, in 2012, an amendment was brought forward that would have required supplement makers to register their products with the FDA and provide details about their ingredients.

Hatch fought the amendment, which he typified as “a misguided presumption that the current regulatory framework for dietary supplements is flawed.”

At the moment there is continued pressure on the Office of the New York State Attorney General to defend the testing methods used. Any additional insights and conclusions into those testing methods may or may not have an impact on herbal supplement lawsuits that are now in the pipeline. Pundits also wonder about the plausibility of this most recent issue, coupled with health concerns that have occurred since 2012, resulting in a renewed push for increased oversight of a hugely popular and growing industry.

There is a lot to watch - including how supporters and detractors line up in the various camps: those who advocate tighter rules as long overdue v. those who like things just as they are thank you. In the middle are plaintiffs who have either been harmed or defrauded.

Stay tuned…

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