Posts Tagged Dietary Supplement Health and Education Act of 1994

US Department of Justice Goes After Supplements

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.

Now the US Department of Justice (DOJ) is getting in on the fun:

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.

This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.


Posted in: Herbs & Supplements, Legal

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Supplements are the Wild West of health. One Attorney General is out to change that.


Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.

When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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DMAA: Efficacious but is it Safe?

Chinese geranium, apparently a natural meth factory, making that bee a suspect

Chinese geranium, apparently a natural meth factory, making that bee a suspect

by Igor I. Bussel & Andrey A. Pavlov Jr.

Jann Bellamy has recently authored an excellent piece on the limitations of the FDA and how the DSHEA actually protects the profits of supplement manufacturers rather than the health and well-being of consumers. Bellamy used the very poignant and currently “controversial” example of DMAA (methylhexanamine or 1,3-dimethylamylamine) to illustrate her point regarding the loopholes and lack of enforcement power of the FDA. The authors of this piece had been considering writing about DMAA and felt this would be an excellent time to further expound on Bellamy’s work. The goal of this article will be twofold: 1) to discuss the known history and pharmacology of DMAA, especially in regards to the basic methodology for evaluating novel substances or novel uses of substances in the context of lacking randomized, controlled trial-level evidence (i.e. the concept of science vs. evidence based medicine) and 2) how the DMAA story clearly and unequivocally demonstrates how the DSHEA allows for unscrupulous profiteers to game the system with little, if any, consequence and nothing but profit until the cost in lives forces the issue.


DMAA was originally developed by Eli-Lilly in 1948 and then later trademarked as Forthane to be used as a nasal decongestant (there are varying accounts but it seems that Eli Lilly patented the molecule in the early 1940s, trademarked and marketed it as Forthane in 1971 for allergic rhinitis, and then voluntarily withdrew it in 1983). The mechanism of action was vasoconstriction – the blood vessels in the nose would constrict so that less blood flow would lead to less nasal discharge. This is a mechanism used by common OTC nasal sprays like oxymetazoline (Afrin) and is indeed quite effective. However, Forthane was later withdrawn from the market because of significant side effects including headaches, tremors, and increased blood pressure. These effects likely occur because DMAA is structurally similar to amphetamine and as a result, the compound is not only a vasoconstricting agent but is also a central nervous system (CNS) stimulant. 


Posted in: Herbs & Supplements, Legal, Science and Medicine

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Utah Senator Orrin Hatch: A pit bull in defense of the supplement industry

Editor’s note: This weekend was truly NIH grant crunch time. I have to get my final version of my R01 to our university’s grants office by Tuesday, or it might not get uploaded by the July 5 deadline. (Funny how electronic submission, which was supposed to make applicants’ lives easier, seems to have made them harder.) Consequently, I decided to take a few minutes and spiff up a post I did not long ago for my other blog and use it here, mainly because it is particularly relevant to our usual SBM topics. I’ll be back next time with something new.

The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.

Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:

It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, foreign and domestic. His name is Senator Orrin Hatch (R-UT), and he was just the subject of a writeup in the New York Times last week referring to him as a “natural ally” of the supplement industry:

Posted in: Herbs & Supplements, Pharmaceuticals, Politics and Regulation

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Supplement Regulation: Be Careful What You Wish For

A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.

Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:

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. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.


Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?


One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:

Posted in: Herbs & Supplements, Nutrition, Politics and Regulation

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