07262017Headline:

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Greg Webb
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Dietary Supplements or Snake Oil—Where’s the FDA in All of This?

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Once there was a Bureau of Foods at the U.S. Food and Drug Administration (FDA). There was also a Bureau of Drugs. Both bureaus had some teeth, so to speak, and these federal government entities were charged with the mandate of regulating the contents of and approving food and drug products to be sold in the U.S.—every food and drug that was processed and ultimately went into people’s mouths or, as in the case of drugs, every product used to treat people medically. (The latter also included medicinal rubs, oils, ointments, lotions, potions and creams.)

From medicines to breakfast cereals, from its inception throughout the latter part of the 20th century, the FDA, originally run by the U.S. Department of Health, Education and Welfare (DHEW) until the late1970s—and now, by its mostly-health policy-oriented organizational successor, the U.S. Department of Health and Human Services (DHHS)– had the power to say “yay” or “nay” in the approval process of food and drug products. For the most part, pharmaceutical manufacturers and food processing companies respected the FDA’s approval process and regulations and complied with FDA requirements. If a food or drug product didn’t meet FDA spec, it was back to the drawing board for the company. For the most part, one can safely say that American companies and their employees took pride in the excellence of manufacture and processing of food and drug products in the 20th Century.

It’s the 21st Century now, and the tectonic plates of food and drug processing in the U.S. apparently have moved. As a producing nation, America is faced with global demand for American products, and we have strived to fuel this phenomenon by attracting new consumers for American products. Could it be that in trying to satisfy and grow the demand for American products in the 21st Century, we are sacrificing the quality of manufacture of our own food and drug products through watered-down oversight?

The mission of FDA’s “Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. [But] CDER does not test drugs.” The diffuse approval process of food and drug products may be contributing to a lowering of quality food and drug products. Some dietary products on the market are hardly being scrutinized in the regulation process, and these are the dietary supplements.

In searching the Internet and viewing the advertisements alone, it’s apparent that dietary supplement products abound in number. Sales of dietary supplements reached $23.7 billion in 2007 alone. The dietary supplement manufacturers’ and distributors’ lobby is large, powerful and has lobbied Congress formidably. Little has been done to regulate dietary supplements since the FDA deemed ephedrine-containing over-the-counter drug products risky in 2008. And while dietary supplement products have proliferated in the past twenty years—they seem to fly under the radar of the FDA’s approval process.

The FDA states on their website that “FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter).” Isn’t this is a little bit like giving folks a license to steal: “Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.” After it reaches the market? So… anything goes until we, the public, find that its consumption is unsafe? Under the DSHEA, the Dietary Supplement Health E Assurance Act of 1994, supplement manufacturers and distributors are basically responsible for the safety of their products.

Just the phrase, “Dietary Supplements” means different things to consumers, it may signify diet pills, vitamins, minerals, powdered “healthy” meal substitutes, or a host of other products that promise to control one’s appetite, slenderize quickly, eliminate unsightly belly fat, or boost one’s immune system, to name only a few of the claims. Simply surveying the field of products—and there thousands on the market today–is daunting.

And there are apparently responsible dietary supplement manufacturers of long-standing, who stringently self-police their brands, such as NatureMade (the “nation’s #1 best-selling brand of vitamins), One-A-Day® (owned by Bayer), Amway™, and Shaklee™. But there are also manufacturers of products that pepper the market which may have serious negative side effects. Take the product Hydroxycut™, for instance, advertised as “Clinically proven, dietary supplements” and sold by GNC. The negative effects are well publicized and include insomnia, nervousness or restlessness, indigestion or heartburn, shakiness (tremors) or jitteriness, and increased urination. There are contraindications for these products as well, some should not be taken by people on high blood pressure medicine or beta blockers, some should not be taken by people with kidney disease. Some of the dietary supplement products contain caffeine and other stimulants.

There are some dietary supplement producers whose products go way beyond the above-mentioned negative effects. While information on their negative side effects is also available to the public, that doesn’t seem to slow down the purchase of products which promise to slim quickly or swiftly reduce belly fat. Apparently, the American public needs an oversight organization with real teeth that will help protect the consuming public from unhealthy dietary supplements which are available.