The United States Food & Drug Administration is one of the most important consumer protection agencies in the country, and arguably in the world. It’s charged with assuring food safety, drug safety and efficacy, and prevention of health fraud. Americans feel safe with their drugs and food supply because the FDA is on the job. There are just two problems. The first is the problem of chronic underfunding by Congress. While some of the dollar shortage has been improved under the Obama administration, the increase for fiscal year 2012 was only $50 million, while the sequester is expected to reduce 2013 funding by $209 million.
There’s more. While, as a general thing, the FDA staff is overworked, there’s a critical area where they’re underworked – dietary supplements. These are products that are sold as food or nutritional products rather than as drugs. These include vitamins, minerals and fish oils – which are pretty much okay – but also include what might be called “herbal remedies,” although they’re not allowed to call themselves remedies. As long as the products don’t make claims of use in treatment of disease, contain a recognized nutrient, and are labeled “dietary supplement” they’re pretty much off the hook as far as FDA approval goes.
While drug manufacturers have to demonstrate that a product is safe and effective (safe as compared with leaving a disease untreated) before they can be marketed, under the Dietary Supplement Health and Education Act of 1994, when it comes to supplements “(c) BURDEN OF PROOF. — In any proceeding brought under subsection (a), the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.” Proving that a product is dangerous would require either controlled studies, which the FDA lacks the resources for, or diligent reporting of adverse effects by the supplement manufacturers.
Dr. Dan Fabricant, director of FDA’s Division of Dietary Supplement Programs, came to the agency after serving as vice president of the Natural Products Association—the largest nonprofit in the US that’s dedicated to the makers and distributors of natural products. In other words, he had a solid knowledge of what’s happening on the other side. On April 25, 2012, Dr. Fabricant said the FDA had a pretty good indication that manufacturers were failing to report adverse events, and in some cases, were failing to provide a contact address on their labels so that adverse effects could be reported.
This lack of regulation has gained national attention since the death of Michael Lee Sparling, a 22-year-old Army private. Pvt. Sparling had taken a supplement named Jack3d (pronounced “jacked”) which has been widely used to increase work-out intensity, One of the key ingredients in the product is geranium extract, which contains a stimulant called dimethylamylamine, or DMAA. This stimulant belongs to the same family of drugs as norepinephrine, ephedrine, and amphetamines – with strong similarities between the plant and animal chemical structures. When restrictions were placed on the use and sale of amphetamine, some companies turned to ephedrine. When that was restricted, geranium extract became popular. While reason tells us that geranium extract is as dangerous as ephedra, which is restricted, it will take more deaths to show the product is unsafe, and those deaths would have to be reported. Without a report, the FDA would have to run studies to prove the products are dangerous, and they don’t have the money to pay for the studies.
Meanwhile, the advocates of supplements have raised a drumbeat that the FDA is trying to gain full control of all supplements. Back in 2005, Congressman Ron Paul introduced the Health Freedom Protection Act saying “The American people have made it clear they do not want the federal government to interfere with their access to dietary supplements, yet the FDA and the FTC continue to engage in heavy-handed attempts to restrict such access. The FDA continues to frustrate consumers’ efforts to learn how they can improve their health even after Congress, responding to a record number of constituents’ comments, passed the Dietary Supplement and Health and Education Act of 1994 (DSHEA). FDA bureaucrats are so determined to frustrate consumer access to truthful information that they are even evading their duty to comply with four federal court decisions vindicating consumers’ First Amendment rights to discover the health benefits of foods and dietary supplements.”
So we can go out and buy products that don’t work, and products that may well be toxic, and the FDA has neither the staff nor the congressional mandate to stop us. Times like this, Kris Kristofferson’s famous lyric “freedom’s just another word for nothing left to lose” sounds like a way of saying “your money or your life.” Or maybe both.
Sam Uretsky is a writer and pharmacist living on Long Island, N.Y. Email firstname.lastname@example.org.
From The Progressive Populist, April 15, 2013
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