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America Needs More Regulation of Dietary Supplements

In the United States, two-thirds of us take a dietary supplement of some kind, and we spend approximately $37 billion a year on vitamins, minerals, herbs and other botanicals [substances obtained from plants]. Most of us take them because we have heard that they have some positive impact on our health, but the truth is that few have any beneficial value.

The industry, as a whole, might remind you of the days in which street vendors hawked patent medicines promising that they would cure baldness, arthritis, and depression. Today, there is more regulation and manufacturers have to list the ingredients on the label, but according to recent studies, sometimes even that is misleading.

The federal law that regulates dietary supplements, the Dietary Supplement Health and Education Act (DSHEA) of 1994, states that supplements must be manufactured free of contamination or adulteration, but allows them to be sold without providing proof that they have some beneficial value. Essentially, they are classified as food products, not medicines. So, unlike prescription and over-the-counter drugs, manufacturers don't have to prove to the Food and Drug Administration [FDA] that their product is effective. Instead, the law makes the FDA demonstrate that a product is harmful before they can take it off the market, and that rarely happens.

David Kessler, commissioner of the FDA when DSHEA was approved, said this about the Act:

"The 1994 Dietary Supplement Act does not require that dietary supplements (defined broadly to include many substances, such as herbs and amino acids, that have no nutritive value) be shown to be safe or effective before they are marketed. The FDA does not scrutinize a dietary supplement before it enters the marketplace. The agency is permitted to restrict a substance if it poses a 'significant and unreasonable risk' under the conditions of use on the label or as commonly consumed" ...
... "Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, since its members apparently believe that few of these products place people in real danger. Nor does the public understand how potentially dangerous these products can be."

Peer reviewed research has found that a few supplements have benefits, but the number is quite small. The Washington Post recently interviewed several experts about supplements, Carol Haggans, a scientific and health communications consultant with the Office of Dietary Supplements, about vitamins and minerals, and Craig Hopp, deputy director of the National Center for Complementary and Integrative Health, about botanical and other kinds of supplements.

Tamar Haspel of the Post asked them if studies had found value in any of the most common supplements.

Washington Post: “It’s a short list,” Hopp told me. “Ginger for nausea, peppermint for upset stomach, melatonin for sleep disruption. And fish oil does seem to show some promise for cardiovascular disease, although some of the data is conflicting.” He went on to list some of the supplements that haven’t shown benefits in trials: turmeric, St. John’s wort, ginkgo, echinacea."
"On the vitamin and mineral side, Haggans pointed out a couple of wins. Folic acid reduces risk for fetal neural tube defects, and it is widely recommended for women who may become pregnant. Vitamin B12 in food is sometimes poorly absorbed, she told me, and supplements can help in people over 50 (and vegans, because B12 comes from animal products). Then there’s a combination supplement that may slow the progression of macular degeneration. It’s also possible a daily multivitamin may decrease some disease risk."

There are a few others like a combination of calcium and vitamin D for reducing risk of osteoporosis, but the list is short. And, there are risks involved as documented in a new study by C. Michael White, Head of the Department of Pharmacy Practice at the University of Connecticut. His study of dietary supplements found that consumers put themselves at risk when they use products not independently verified by reputable outside labs.

White, The Conversation: "Heavy metals, which are known to cause cancer, dementia and brittle bones, contaminate many diet supplements. One study of 121 products revealed 5% of them surpassed the safe daily consumption limit for arsenic. Two percent had excess lead, cadmium and aluminum; and 1% had too much mercury. In June 2019, the Food and Drug Administration seized 300,000 dietary supplement bottles because their pills contained excessive lead levels."
"Bacterial and fungal contamination in dietary supplements is not uncommon. In one assessment, researchers found bacteria in all 138 products they investigated. Toxic fungi were also in many of the supplements, and counts for numerous products exceeded the acceptable limits set by the United States Pharmacopeia. Fungal contamination of diet supplements has been linked to serious liver, intestinal and appendix damage."

White, goes on in his article to list many other dangers, and suggests that before you consider taking a supplement, you should check to see that it was tested by an independent laboratory.

The Conversation: ... "I recommend that consumers should not purchase supplements without verification from one of three highly regarded independent laboratories: the aforementioned United States Pharmacopeia, NSF International and The United States Pharmacopeia is an organization that sets reference and quality standards for prescription medication and food in the U.S.; the NSF International is an independent group that assesses safety and risk for food, water and consumer products; and is a company started to verify product quality for consumers that are paying members. These laboratories conduct an initial analysis and then perform periodic unannounced assessments of the products; those with the appropriate amount of active ingredient, and without contamination or adulteration, can put the United States Pharmacopeia, NSF and seals on their bottles. CVS announced that all products sold at its stores going forward will need to provide the company proof of quality. Other major retailers should follow suit."

Ultimately, however, Americans should be able to expect more than just product safety. The Dietary Supplement Health and Education Act needs to be updated to give the FDA the power to take products off the market when their manufacturers can't prove they have some benefit to the public. Until then, if you have questions about the effectiveness of various supplements, you can consult the National Institutes of Health fact sheets here.

#health #news #research #science

By: Don Lam and Curated Content

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