Who Polices Food Supplements and Herbal Remedies?

By SAM URETSKY

Sen. Orin Hatch represents the state of Utah and the food supplement industry, hopefully in that order. On June 20, 2011, the New York Times published a report headlined “Support Is Mutual for Senator and Utah Industry.” “Nutritional supplements” are products sold over the counter, usually labeled as herbal remedies but occasionally by chemical names such as melatonin or DHEA (dihidroepiandrosterone) which, thanks in large part to Sen. Hatch, are exempt from Food & Drug Administration review.

Senators may be willing to fight over the defense budget, education, Social Security, and the availability of energy inefficient incandescent light bulbs, so they’re less inclined to argue about restrictions on mugwort, male fern and rupturewort (these herbs were among those evaluated by the German Commission E, their equivalent of our FDA. The German commission reported insufficient evidence of efficacy to approve these substances for medicinal use, but no similar review is required in the United States.)

Prescription drugs are required to undergo extensive testing to demonstrate safety and efficacy, and require an order from a physician, surgeon or other practitioner who is qualified by education an experience to evaluate the risks and benefits. This system doesn’t always work, but it’s an honest attempt to maintain health and safety.  Products labeled “nutritional supplement” don’t have to prove anything. Some are legitimate, safe and effective and properly prepared and in the appropriate doses, but they’re sitting on the same shelves as other products that at best are worthless and may be dangerous.

On Feb. 3, 2015, the Associated Press reported that New York Attorney General Eric Schneiderman had sent letters to GNC, Target, Walmart and Walgreens, calling on them to stop selling supplements that were mislabeled. Products from stores in these chains were found to contain none of the substances on the label. From the AP report: “bottles of Walmart-brand echinacea, an herb said to ward off colds, were found to contain no echinacea at all. GNC-brand bottles of St. John’s wort, touted as a cure for depression, held rice, garlic and a tropical houseplant, but not a trace of the herb.”

In the past, analysis of these products was difficult, and while efforts were made to cut back on medical quackery, the labels were assumed to be accurate. Even then most of the products were worthless simply because they would have contained too little of the claimed herbs even if the labels were accurate. Herbal remedies can be effective if they contain enough of the active principle, which would usually be measured in grams – but we’ve become used to milligram doses, so the products are offered in milligrams. In other words, instead of taking 95 milligrams of caffeine, which is a stimulant, they’re offering 95 milligrams of coffee, which is a waste of money – and that assumes the product is accurately labeled, which has become doubtful.

Unfortunately, Congress won’t let the FDA do anything. On March 19, the FDA issued a report “Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement — Consumer Warning About Potential Health Risks,” and while the FDA wasn’t exactly ready to take on the complimentary remedy establishment, they almost hint that maybe homeopathic remedies aren’t the best choices for a condition that can be fatal. After telling readers how to identify a homeopathic product, the FDA advises “Speak to your health care provider if you think you or your child may have asthma. Consumers with asthma can take an active role in managing their condition by making certain they have appropriate treatments on hand in the event they experience an asthma attack or a worsening of asthma symptoms, and by consulting with a health care provider when needed.”

There is no attempt to even describe what homeopathy is – a theory of medicine based on the theory that water remembers whatever substances used to be dissolved in it. This made some sense in 1776, when Dr. Benjamin Rush (a signer of the Declaration of Independence) was trying to cure yellow fever with mercury bichloride and teaching that there is really only one disease which could be treated with bloodletting and mercury. Homeopathy, which was relatively harmless, at least gave the patient a fighting chance. Homeopathy may still have had some value in 1842 when Oliver Wendell Holmes M.D. (father of the Supreme Court justice) wrote, “Homeopathy and Its Kindred Delusions.” Holmes was one of the early advocates of hand washing, which may have been the point in time where medical care did more harm than good. It may even have been marginally useful in 1938, when Sen. Royal Copeland (D-N.Y.), a homeopathic physician, insisted that homeopathy be recognized in the  Federal Food, Drug, and Cosmetic Act of 1938 – and nobody has been able to get the law changed since then.

And so, to quote the New York Times, “... the Food and Drug Administration does not have enough power to keep fraudulent or dangerous products from reaching store shelves. The FDA is restricted by a 1994 federal law — sponsored by Sen. 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.” Similarly, it can’t do much about homeopathy with is part of the basic enabling legislation that led to the creation of the FDA.

At least we know that Democrats and Republicans can work together – sort of – but it’s less encouraging than it sounds.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y. He has worked as a consultant to the Postal Inspection Service on medical quackery. Email sdu01@outlook.com.

From The Progressive Populist, May 1, 2015

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