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

[HuckleB]

https://www.sciencebasedmedicine.org/holding-the-supplement-industry-to-account-can-we-learn-from-tobacco-regulation/

"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?

Whether you’re a supplement user or not, one thing we can probably all agree on is that these products should be manufactured to high quality standards. Setting aside any efficacy questions, consumers should get what they pay for, and be able to trust that what’s on the label is actually in the bottle. Adulterated supplements, or supplements that contain undeclared ingredients (from potential allergens to houseplants) are fraudulent and prohibited – yet they continue to appear on the market. Why this occurs isn’t unexpected. Current regulation doesn’t require manufacturers to demonstrate quality before products are sold, nor does it to hold manufacturers to account when things go wrong. That’s the reality with supplements today. And we can trace the cause (in the United States, at least) to a pivotal piece of legislation.

Supplement regulation: A travesty of a mockery of a sham of a mockery of a travesty of two mockeries of a sham

While the US Food and Drug Administration (FDA) effectively sets the worldwide standard for pharmaceutical regulation, the same cannot be said for its regulation of supplements. The overall quality of supplements sold in the United States is unclear. Adulteration, virtually unheard of with drug products, is a regular complaint with supplements. This shouldn’t surprise, as the FDA is at the mercy of legislation deliberately designed to prevent effective oversight. The Dietary Supplement Health and Education Act of 1994 (DSHEA) was an amendment to the U.S. Federal Food, Drug and Cosmetic Act that established the American regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from many of the requirements that are in place for prescription and over-the-counter drugs. Amazingly, it puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective. A weak regulatory framework, which doesn’t require pre-sale testing of product quality and finished product specifications, might be expected to result in a weaker commitment to quality. Yet consumers are not aware of this. After two decades of DSHEA, many consumers believe that supplements are approved by the FDA, that supplements are tested for product quality, and that adverse events are disclosed to consumers. DSHEA does not require this, and there is no assurance to consumers it is occurring.

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Just like the gradual public health push for tobacco legislation, recent actions at the federal and state level are encouraging – legislators are recognizing the fallacy of supplement safety, and are finally moving to put consumer protection ahead of industry interests. The industry’s inability to keep adulterated products off the market does itself no favours, and public support may dwindle if it’s recognized that the industry, to date, really hasn’t taken product quality seriously. What we argue for here at SBM is a consistent approach to quality and safety, where claims of effectiveness are backed by good evidence, and health professionals and consumers can use these products in science-based ways. The challenge we face is that the supplement industry will fight this tooth and nail. It took decades for tobacco. Comparing supplements to tobacco is definitely provocative. But given what we don’t know about supplement quality and safety, the comparison may be more apt than it appears."


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