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Posts Tagged Dietary Supplement Health and Education Act of 1994

Supplements, Lies, and a Lengthy Transcript

Thanks, Congress, for making bull testicles available as a dietary supplement!

Thanks, Congress, for making bull testicles available as a dietary supplement!

On October 21, 1993, there was a hearing before the U.S. Senate Committee for Labor and Human Resources, with the long-winded title:

Examining How the Federal Government Should Regulate the Marketing and Use of Dietary Supplements and Related Measures, Including S. 784, To Strengthen Federal Standards with Respect To Dietary Supplements.

S. 784, sponsored by Sen. Orrin Hatch, would eventually be enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA).

I discovered this bit of Congressional theater when doing research for my recent talk at NECSS. Scott Gavura and I joined forces to present “Natural Disaster: Dietary Supplements.” Scott focused on pharmacology, while I talked about FDA regulation of dietary supplements (or lack thereof). Thanks to him, I now have a rudimentary knowledge of pharmacokinetics, the science behind how a drug or supplement works (or doesn’t) in the body. If you haven’t read his post from last week explaining this, and more, you should.

Reading the lengthy hearing transcript (well, ok, a lot of it) confirmed my suspicions that the fix was in even before the gavel went down to begin the hearing. What I had not realized was, at least according to some proponents of DSHEA, part of the deal was that consumers would have access to accurate information backing efficacy claims made for supplements and their safety. Nor had I realized that the weaknesses of DSHEA, which have become painfully obvious in the 20-plus years since the law was passed, were anticipated from the get-go and that Congress was well-informed of what they were. Finally, I was not previously aware of the provenance (shall we say) of the “experts” asked to testify at the behest of Sen. Hatch.

First, let’s set the stage on which this drama plays out, according to two excellent books on dietary supplements, Natural Causes and Vitamania. In 1991, Congress passed the Nutrition Education and Labeling Act (NELA). Most famously, NELA, for the first time, required that all foods bear the now-familiar nutrition label. It also required that any health claims made for foods be backed by “significant scientific agreement.” Rep. Henry Waxman and others wanted the same standard applied to dietary supplement health claims. After all, if food companies had to meet a certain standard to make health claims for, say, calcium in their products, why shouldn’t claims for the health benefits of calcium in dietary supplement form be held to the same standard? But the supplement industry knew it couldn’t survive under such stringent rules and Sen. Hatch made sure it didn’t happen. All parties agreed to let the FDA decide what standard should be required of supplement health claims and left it at that. (more…)

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

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Where science meets supplements

Various herbal remedies and supplements.

Various herbal remedies and supplements.

For those of you that missed the Science-Based Medicine day at NECSS last week, I’ve put the highlights in the following post:

The supplement industry is big business, and the popularity of these products seems to keep growing. I once worked at a small independent pharmacy that specialized in supplements, homeopathy and “alternative medicine” as way to differentiate itself from the big chain pharmacies. A lot has changed in a decade. Today, even national chain pharmacies have aisles and aisles of herbal remedies, dietary supplements, and even homeopathy. Yet despite the preponderance of products on store shelves, there is little evidence to suggest that supplements are necessary or even improve health (and may even cause harm). The right for consumers to buy products for themselves, and make their own self-care decisions, is an important one that respects individual autonomy. Regrettably, the regulations of these products are so weak and ineffective that the sale of these products quite possibly harms, rather than helps, the average consumer. The system is rigged against consumers, and it prevents the use of supplements in an evidence-based way. (more…)

Posted in: Herbs & Supplements

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The consumer lab rat: More questions about supplement safety

Laboratory Rats
Do you take a vitamin or dietary supplement? Over half of all American adults do, making this a $30 billion dollar business. Many of us even take supplements in the absence of any clear medical or health need. I’m often told it’s a form of nutritional “insurance” or it’s being taken for some presumed beneficial effect – like Steven Novella outlined in yesterday’s post on antioxidants. We love the idea of a risk-free magic bullet that improves our health and wellness. Especially one that avoids what are presumed to be toxic, unnatural drugs. Supplements are marketed as safe, natural and effective, and there is no question that messaging has been effective.

I used to take supplements. For me it was multivitamins. But as I’ve taken a closer look at the evidence for supplementation, my personal behaviors changed. The primary reason is a lack of evidence. There is no evidence to suggest that vitamins offer any health benefits in the absence of deficiency. The balance of evidence suggests that routine multivitamins are unnecessary for most people. Vitamins should come from your food, not from supplements. More generally, looking at the broader category of supplements that range from probiotics to herbal remedies, there is little evidence to support most of them. With a few exceptions, the research done on dietary supplements is unconvincing and largely negative. If you don’t supplement, you don’t seem to be missing out on any tremendous health benefits.

Going beyond the lack of evidence, there’s an even more compelling need for consumers to be wary of them. The safety of supplements is increasingly being called into question. Evidence has emerged demonstrating that quality standards for supplements sold in many countries are erratic and unpredictable. The root cause seems to be regulatory systems that prioritize manufacturer interests ahead of consumer protection. With supplements, products are effectively being tested for safety after they are marketed, and the consumer is the unwitting research subject. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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What’s in your Traditional Chinese Medicine?

A study found 92% of Traditional Chinese Medicine was contaminated with drugs, heavy metals, or animals including cat, dog, rat and pit viper.

An analysis of 26 Traditional Chinese Medicine products found 92% were contaminated with pharmaceuticals, heavy metals, or the DNA of animals, including traces of cat, dog, rat, or pit viper.

Two weeks ago I detailed the pervasive problem of poor quality supplements. The main reason for this seems to be weak regulatory standards that prioritize the rights of manufacturers to sell supplements over the rights of consumers to buy safe, high quality, properly-labelled products. Call it “health freedom“, where the freedom belongs to producers, who in many countries are largely freed from most of the quality and safety regulations that are in place for licensed prescription and non-prescription pharmaceuticals. The result of weak regulation is that few supplements sold on the market today have been properly tested for safety or effectiveness, and there are few quality standards for the production of these products.

Not surprisingly, there are persistent signs that consumers may face real risks to their health from using these products. Now a new study from Australia confirms what past studies have already shown: adulterated and contaminated herbal remedies are the rule, rather than the exception. They often contain undeclared ingredients ranging from potential allergens to heavy metals to endangered species. (more…)

Posted in: Health Fraud, Herbs & Supplements, Naturopathy, Politics and Regulation, Public Health, Traditional Chinese Medicine

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Holding the supplement industry to account: Can we learn from tobacco regulation?

When it comes to supplements, you can't trust what's on the label

When it comes to supplements, you can’t trust what’s on the label

The idea that “natural” products are safe and effective has been so effectively marketed to us that many don’t recognize it as a fallacy. Much of the supplement industry is built around an appeal to nature. Supplements are described as natural, gentle, and “holistic”. Medicine, especially prescription drugs, is the opposite. They’re “chemicals”. They’re risky and dangerous – just look at that list of side effects! Supplements are packaged beautifully, have impressive claims, and are for sale at Whole Foods. Drugs are hazardous: They may come in a plain vial, with warning labels, detailed information sheets, and cautious statements about their effectiveness. Is it any wonder that many consumers, when faced with health concerns or medical issues, instinctively think of supplements as a safer alternative? Purveyors of supplements and alternative medicine have leveraged this fallacy so effectively that it’s even guided the regulations that allow their sale. Regrettably, the result is a marketplace that puts consumers’ interests last. The supplement industry has completely stacked the odds against the consumer, challenging their ability to make informed decisions about their health. Most supplements on the market have never been properly tested for safety or effectiveness. And those that have been tested have largely been shown to be ineffective – or in the case of products like vitamins, often unnecessary. And while there are undoubtedly some ethical companies out there, the industry is regularly revealed to resemble a wretched hive of scum and villainy. Despite this, the industry has gone from success to success – in terms of sales, at least. In 1994 supplement sales were about $4 billion in the US. It’s now a $37 billion industry that is remains only lightly regulated – or largely unregulated. With recent action taken against fraudulent products, there are more questions than ever about how to force the supplement industry to make consumer protection a priority. A new paper in Drug Testing and Analysis makes a provocative suggestion: Local and state governments already regulate another hazardous product: tobacco. Can lessons learned from the tobacco wars improve the safety of supplements? (more…)

Posted in: Epidemiology, Health Fraud, Herbs & Supplements, Politics and Regulation, Public Health

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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.

(more…)

Posted in: Herbs & Supplements, Legal

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“Safe” dietary supplements can land you in the emergency room

Dietary supplements
If there’s one thing I’ve been consistent about, it’s that, however ridiculous all the other woo I routinely discuss here is—homeopathy, reiki, reflexology, I’m talking to you and your friends—herbal medicine and supplements might have value because they might have a physiological effect that is beneficial in treating or preventing disease. Of course, if that’s the case, it’s because the herb or supplement contains chemicals that act as drugs. They’re “dirty” drugs in that they are mixed with all sorts of other substances in the herb or supplement that might or might not have effects, which means that different lots of the herbs or supplements often have different activity, but they are drugs nonetheless. That’s why, for instance, doctors don’t tell patients to chew on foxglove leaves when they want a patient to get digoxin. Digoxin is a powerful drug with a relatively narrow “therapeutic window,” meaning that the difference between the levels of the drug in the blood needed for therapeutic effect are not very far from toxic levels; so predictable, reliable drug content is essential. I just learned a while ago that within the living memory of some older physicians digoxin actually was prescribed as crude extracts, which was very difficult and dangerous, hence the necessity of purification. In other cases, (such as Artemisinin, for which Youyou Tu was recently awarded the Nobel Prize in Physiology or Medicine), crude plant extracts do not contain sufficient quantities of the active component, necessitating its isolation, purification, and, in some cases, chemical modification to increase its absorption, stability, or activity.

One thing that proponents of herbal medicine and supplements often forget, though, is that if herbs or supplements can have potentially beneficial effects (albeit difficult to regulate effects due to the crude, impure nature of the extracts often used) because they contain drugs, then herbs and supplements can also produce adverse events, again, because they contain drugs. You can overdose on herbs and supplements. This point was recently reinforced by a new study by Geller et al. published last week in the New England Journal of Medicine (NEJM), entitled “Emergency Department Visits for Adverse Events Related to Dietary Supplements.” It was carried out by investigators from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, and Chenega Government Consulting; and the Center for Food Safety and Applied Nutrition and the Division of Public Health Informatics and Analytics and the Division of Dietary Supplement Programs, Food and Drug Administration. The title pretty much tells you what the study is about, and what the study is about is that dietary supplements cause a lot of visits to the emergency room every year; 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year can be attributed to adverse events related to dietary supplements.
(more…)

Posted in: Herbs & Supplements, Politics and Regulation

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This stimulant can kill, yet you can legally buy it online. Why?

Caffeine Powder

This stimulant drug is highly toxic and perfectly legal.

If there’s one thing that unites all countries and cultures, it’s our love of caffeine. Whether it’s coffee, tea or other foods, caffeine is the most widely consumed drug in the world — more than alcohol, and more than tobacco: 90% of adults worldwide consume caffeine daily. At doses found in food and beverages, the effects are predictable and the side effects are slight. But natural or not, caffeine is a drug; isolate the pure substance, and the risks change. It would be difficult for most people to drink 16 cups of coffee in a row, but that’s the equivalent of just one teaspoon of caffeine powder. If that doesn’t hospitalize you, a tablespoon of the powder will probably kill you. Yet despite the risks, there are no restrictions on the sale of caffeine powder. You can buy a 1kg bag for $35, which provides the caffeine of about 5,000 cups of coffee. Caffeine powder is freely available to buy because regulators treat it differently – not because of its inherent properties, but because it’s “natural” and sold as a dietary supplement rather than a drug. This is a regulatory double-standard that harms consumers. It’s leaving a body count. And it needs to change: (more…)

Posted in: Herbs & Supplements, Politics and Regulation, Public Health

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

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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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Searching for the supplement in your supplement

Should you trust what on the label?

Is what’s on the label really in the capsule?

Most of us are fortunate to live in countries where we don’t have to worry about counterfeit drugs. We can be confident that the prescription we receive, or the drugs we purchase from the pharmacy, are of high quality and contain exactly what’s on the label. But in these same countries, there’s another group of products where the risks of counterfeits are very real – it’s among the dietary supplements that are often found on the same shelves. Dietary supplements are not regulated in the same way as drug products. The American supplement industry is a multi-billion dollar free-for-all with little meaningful safety or quality regulation. Supplement quality and safety issues are in the media regularly as a result. The most recent example comes from the New York State attorney general’s office. It has accused four large retailers of selling supplements that failed to contain labelled ingredients. Testing the products with a technology called “DNA barcoding”, the AG’s office concluded that most of the products contained little to none of the labelled ingredient. And they also found ingredients that were not disclosed on the label. The AG’s office has demanded these products be removed from store shelves, and the stores stand accused of fraud. (more…)

Posted in: Herbs & Supplements

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