It is an odd conundrum in federal government oversight. While herbal supplements are virtually unregulated by the FDA because they are not drugs, there is a certain efficacy to their use. They do something yet the government is only interested in regulating them after the fact. In a recent crackdown, we now see how far unscrupulous companies can go, by offering very little of what the label says is in it. Now that gets the governments’ attention. If regulatory efforts were put into play before the fact perhaps this “jiggery-pokery” would be less likely to happen. If you are manufacturing a product, don’t cut corners and submit studies and trials not based on the formula in the bottle. Nothing ruins an entire billion dollar industry than cost cutting bad apples who take lack of regulation as an invitation to put lipstick on a pig and call it a cow. Shame on y’all.
The Attorneys General of several states recently announced a crackdown on unsafe herbal supplements. A statement by New York Attorney General Eric Schneiderman “announced the formation of a coalition of state attorneys general from Connecticut, Indiana and Puerto Rico to further investigate the business practices of the herbal supplement industry.
This multistate partnership brings together top law enforcement officers representing nearly 30 million Americans as they seek to ensure that herbal supplement manufacturers and retailers comply with the law.”
Four national retailers—Walmart, Walgreens, GNC, and Target—removed herbal supplements from their shelves in the wake of an investigation by the New York State attorney general’s office which found that the “health” medications were badly mislabeled.
Bottles of herbal pills, for example, often contained doses of the active ingredient that were so small as to be ineffective—when the supplements contained any of the herb at all. Often the consumers were buying products that were contaminated or included inert, inexpensive fillers such as powdered rice.
In fact the investigation 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,” according to “The New York Times.”
Even worse, “a popular store brand of ginseng pills at Walgreens, promoted for ‘physical endurance and vitality,’ 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.”
Supplements are not regulated by the Food and Drug Administration because they are not marketed as drugs. According to the Dietary Supplement Health and Education Act of 1994, “The dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed… Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.”
In fact there is no requirement at all that these substances be scientifically tested for safety or efficacy, and many have in fact been proven not to be effective for the conditions they are used. The vitamin and herbal supplement industry is a multi-billion dollar business, and lobbied hard to keep their products from being regulated by the FDA. As a result, the FDA can only step in when something goes wrong, after people have been injured or killed by natural herbs.
That happened in 2004, when the FDA banned ephedra, an herbal remedy used in traditional Chinese medicine. Millions of consumers took the herb assuming it was natural, safe, and effective—until the supplement was linked to over 100 deaths.
The consequences of mislabeled supplements can be severe; in 2010 health guru Gary Null, nutrition author and marketer of dietary supplements including “Gary Null’s Ultimate Power Meal,” claimed that he nearly died after taking his own supplements. Null sued the manufacturer, saying he experienced kidney damage, pain, and fatigue from consuming the Power Meal because the manufacturer put 1,000 times the correct dose of Vitamin D in his product.
Efforts to regulate the herbal supplement industry have met with fierce resistance from several quarters including longtime supporter Sen. Orrin Hatch; the supplement industry itself (which claims it can self-regulate and calls examples like those uncovered by the New York Attorney General’s office isolated incidents); and alternative medicine advocates who suggest that efforts to regulate supplements are unwarranted.
Dr. Harriet Hall, a retired Air Force surgeon and writer for the Science-Based Medicine blog and “Skeptic” magazine, provided an overview to Discovery News: “The majority of our drugs come from plants. We developed the science of pharmacology because herbal medicines vary naturally in strength and quality, depending on factors like what kind of soil the plant was grown in and what time of year it was harvested. Identifying, isolating, and purifying the active ingredient or synthesizing it allows us to control the dose and improve safety.
“Prescription drugs are carefully regulated and can be trusted to contain what the label says. Herbal medicines are like street drugs: you don’t know for sure what you’re getting, and they could hurt you.”