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 at health food stores and increasingly, taking space in pharmacies. 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.
Herbals and botanicals: Crude drugs of vegetable origins
One of the bizarre aspects of DSHEA (and similar regulation, such as what you can find in Canada) is that what regulations consider “supplements” is a disparate mix of products that vary in their risk to consumers. Some supplements are completely synthetically manufactured, such as certain vitamins. These products are probably the closest to drug products (and in some cases, are considered drugs). They can have specific and genuine, established uses (e.g., folic acid in prenatal vitamins for preventing neural tube defects). These supplements can be assayed and tested, and can be easily manufactured to the same standard as conventional drug products.
But the category of “supplement” also includes herbal remedies – which I would argue shouldn’t be “supplements” at all, as there is no established role for herbs to be “supplementary” to our diet (and some, like DMAA , are classified as “herbal supplements” despite almost certainly not being extracted from plants). Herbal remedies are effectively crude, unpurified drugs – possibly with hundreds of ingredients, and unclear product standards. And when they have a medicinal effect, they are effectively drugs. Many drugs sold today have botanical origins. Acetylsalicylic acid (aspirin) is derived from salicin, found in the bark of the willow tree. Atropine was found in nightshade, and digitalis (digoxin) makes the foxglove plant toxic. Drugs have an edge over herbs because their effects are predictable and reproducible. It starts with identifying, isolating and purifying the active ingredient – and sometimes enhancing it, to reduce side effects or improve its efficacy. Next, you develop a dosage form (e.g., a tablet) that dissolves completely and consistently, and is absorbed reliably. Clinical trials establish if the drug has meaningful effects. None of this is certain or predictable with herbal remedies. Herbals and botanicals are concoctions of chemicals which are rarely “standardized” to contain a predictable amount of an active ingredient, because in most cases, there’s no clear evidence of efficacy. So consumers are completely at the mercy of the manufacturer’s own quality assurance process for a product that may not even have the same ingredients, batch-to-batch.
Botanical and herbal safety: Here be dragons?
Claims made about the efficacy of herbal remedies are typically based on “history of use” claims but often fall short in terms of anything that’s convincing, whether it’s small trials, bad study design – or the fact that it’s not even clear what chemical constituent is having an effect – and if it’s in the dose at all. Without close evaluation, and a standardized product, it’s very difficult to determine if herbal remedies are effective or harmful. The story of Aristolochia is cautionary and telling. Aristolochia is a plant that has been considered to have medicinal properties for hundreds, perhaps thousands of years. Owing to its resemblance to a uterus it has been thought to be effective for childbirth (that’s herbalism “evidence” for you) and has been used as part of traditional Chinese medicine for a number of conditions, none of which were supported by any evidence. The harms of this botanical weren’t identified until recently; when a cluster of Belgian women developed kidney disease and urinary cancers after taking Aristolochia-containing diet pills, the catastrophic harms were revealed. Aristolochia promotes cancer formation through DNA mutations. It’s now classified as a type 1 carcinogen, alongside asbestos and solar radiation. Are other herbals and botanicals causing cancer, or other harms? There’s no routine data collection, so it’s impossible to say for sure. And even if there was, drawing associations is exceptionally difficult: The appearance of an effect like cancer may lag for years, or decades. The harms of a product like Aristolochia are so widespread and diffuse that it’s notable that it took a cluster of cases in Belgium to finally bring this toxicity to light. We may see elevated number of urinary cancer cases in some Asian countries, possibly for decades. Aristolochia is an example of the challenge we face in identifying and monitoring for adverse effects from herbal products. We simply have no clear understanding of the potential for harms, and DSHEA makes it very difficult for anything to change.
Can states learn from tobacco regulation?
Given the likelihood of robust federal consumer protection regulation is remote, the focus has shifted to the potential for state-level action to improve patient safety. It’s worth noting that this is already occurring. Earlier this year the New York State Attorney General issued letters to several retailers demanding that sales cease of mislabelled store-brand supplements. While this inspection was justifiably criticized in part because of its methodology, the state eventually reached an agreement with GNC to implement DNA barcoding nationwide – thereby pushing one manufacturer to adopt standards that are more rigorous than established by DSHEA. Another example was the state of Oregon which, this past April, reached an agreement with Vitamin Shoppe to stop selling supplements containing BMPEA (a stimulant) nationwide.
What else can states do? This is the focus of Rajani Starr’s interesting paper entitled “Should states and local governments regulate dietary supplements?” in Drug Testing and Analysis. The paper is currently open access, so I will touch on the highlights only. Starr points out that states are entitled to create laws to protect health and safety. Tobacco licensing is one example, alcohol is another. States are entitled to impose restrictions on activities like retail sales, and this is an approach that might be desirable from a public health perspective. Not only would it ensure that states knew which retailers were selling products, it could impose signage and marketing requirements – just like you see today with tobacco and alcohol. States could mandate or conduct their own quality assurance testing of supplements, expanding and extending the New York AG’s actions. The risk of licence revocation could ensure more consistent communication about risks, and support any product recall requirements. Starr argues that a one-ingredient-at-a-time approach is insufficient, and states must take broader actions to ensure supplements are of high quality, and that they are used safely. Prohibiting the sale of weight loss and bodybuilding supplements to minors, an approach currently being considered by Massachusetts, is an example of such an approach. Not surprisingly, the natural products industry is fighting it:
If the FDA deemed these supplements (which millions of Americans rely on for their health and fitness) unsafe then they would not be on the shelves in the first place. Also, if they were in fact unsafe then why would it be okay for someone over the age of 18 to purchase them?
Denying those under the age of 18 access to these supplements will likely drive them to purchase them on the internet where they cannot talk to a store salesperson and ask safety questions. Alternatively those under 18 could easily drive across state lines to somewhere they can buy them freely. This action ultimately drives a huge amount of business out of Massachusetts.
By placing the supplements behind the counter for those over the age of 18, you deny them the ability to make the informed decision that they would be able to come to by picking up and comparing multiple supplement containers side by side, looking at the warning and ingredient labels of each.
An appeal to consumer “freedom” for minors to buy potentially adulterated products.
What are the limitations on state action? There are several. Legislation may be limited by “pre-emption” whereby the laws of one level of government (e.g., state) can be overruled by a higher level of government (e.g., federal). The tobacco industry successfully used pre-emption to reverse state-level tobacco control for years. Starr argues that the supplement industry understands pre-emption well, and has successfully argued that DSHEA was written to enable access to supplements. The second barrier to state regulation is the Commerce Clause of the US Constitution. In short, any burden on interstate commerce must be assessed against the benefits they bring. Finally, there is the First Amendment protection of commercial free speech: The tobacco industry used this argument to fight package warnings. The supplement industry has used the same argument in its fight to make treatment-related claims on product packages. What you see today is a product of that battle: “Structure/function” claims that are accompanied by a quack Miranda disclaimer that “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Putting consumers first – Is rational regulation feasible?
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 I and others have argued for 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 (and what we do) about supplement quality and safety, the comparison may be more apt than it appears.
References and additional reading
Starr R. “Should states and local governments regulate dietary supplements?” doi: 10.1002/dta.1926
There are several other new articles in Drug Testing and Analysis that relate to this topic, and are recommended for health professionals and consumers alike:
- The history of efforts to regulate dietary supplements in the USA
- Breaking the gridlock: Regulation of dietary supplements in the United States
- Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ — Hawaii, 2013
- Adulterated dietary supplements threaten the health and sporting career of up-and-coming young athletes
- Consumers’ perceptions of the dietary supplement health and education act: implications and recommendations
- Self-reported side-effects associated with use of dietary supplements in an armed forces population
- Dietary supplements: What’s in a name? What’s in the bottle?
This is a cross-post from Science-Based Medicine. Comments are open at the post.