In my last email, I illustrated the supplement double standard - a tendency to think that supplements are effective and have no side effects. In this email, I will explore how this perception came to be. Why we erroneously think of supplements as being different than drugs.
Drugs and supplements defined
Drugs are defined as compounds that are novel and synthetic. They are synthesized in a lab and not found in nature. Drugs include prescription medications and over-the-counter medications such as Advil or Nexium.
A supplement, on the other hand, is a medication found in nature - a natural medication. It covers any of the following:
* vitamins and minerals
* botanical or herbal products: including algae and macroscopic fungi
* amino acids
* enzymes
One and the same
Approximately 50% of drugs, however, are derived from natural sources. Aspirin, penicillin, cortisone, statins, taxol, colchicine, and opioids to name a few. This makes the dichotomy of medications into natural (supplements) vs non-natural (drugs) misleading. There is no biological difference between supplements and drugs. They both end up targeting the same biologic systems, they both can be beneficial and harmful, and they both should be treated with equal respect and caution. (I will expound on the biologic similarities between supplements and drugs in my next email)
The legal dichotomy of medications
In reality, the natural vs non-natural dichotomy was a product of the law. It was about regulation, ownership, and patentability. Supplements are not patentable because they already exist in nature and drugs are patentable because they do not exist in nature. Lets explore why this medication dichotomy became popularized, and how it changed the way we view medications.
A brief history of DSHEA
Appreciating their immense complexity and potential, the FDA wanted natural medications to fall under its jurisdiction; to be further researched, scrutinized, and regulated like drugs. The supplement industry wanted deregulation. In the 1990’s the fight was coming to a head. In favor of deregulation, senator Orin Hatch, hatched The Dietary Supplement Health and Education Act ("DSHEA”). With help from industry and a large media campaign the act was passed in 1994 (Watch Mel Gibson in this hilarious commercial from the campaign trying to protect the right to his “vitamins”). This took medications found in nature out of the hands of the FDA, leaving the ndustry to regulate itself.
DSHEA says supplements are safe
To justify deregulation, DSHEA had to declare that supplements are safe. To do this, it granted natural medications with the same status as food. Food is safe and does not need scientific approval to be produced or used, neither should medications sourced from nature. It even gave natural medications a new name, “dietary supplements”, reflecting their new status as food. Now if a company wants to release a new supplement, no safety or effectiveness testing is required. Instead, the supplement company will police itself. It is solely responsible for determining the quality and safety of its products. The fox is guarding the henhouse.
DSHEA does not allow any disease claims
There was a price to pay for deregulation. If a supplement could actually treat a disease, it must be potent and have side effects and should be regulated. Thus, supplements cannot claim to treat disease. This was necessary in order for DSHEA to maintain its declaration that supplements are safe.
Turmeric cannot claim to prevent cancer. Zinc cannot claim to treat colds. CoQ10 cannot claim to prevent heart disease. In fact, the following disclaimer is supposed to be added to supplement labels and marketing: “These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.”
Unfortunately, many supplement companies are noncompliant with this restriction. They make specific disease claims or neglect to include the disclaimer. The FTC is unable to police the marketing of some 87,000 supplements in the US - and companies know this.
DSHEA allows structure/function claims
Instead of disease claims, DSHEA allows supplement companies to make structure/function claims. Let me explain what this means. When food is deficient, the structure of the body is compromised. Bones don’t grow, muscles atrophy, etc. Thus, one can claim that food “supports” these structures of the body. Likewise, when food is deficient, the functioning of the body is compromised. The heart won’t pump properly, the immune system will not fight off infection, etc. Thus, one can claim that food “supports” these functions of the body.
With respect to the marketing, DSHEA requires a new language for supplements. Words like “prevents” or “treats” are to be avoided. Instead they should be replaced by “supports“ or “boosts”. Specific diseases are not to be mentioned. Instead they should be replaced by organ systems. For example, DSHEA prohibits “Our supplement treats arthritis”; but would allow, “Our supplement supports joints”. DSHEA would prohibit, “Our supplement prevents the flu”, but would allow ,“Our supplement boosts the immune system”.
It turns out, the ambiguity of the structure/function claim works to the advantage of supplement companies. It has led to a supplement language that is far more appealing and casts a wider net than the one used by drug companies. Wouldn’t you rather take a medication that “boosts the immune system” than one that claims to prevent the flu? A medication that only prevents a flu sounds limited. Why not have the entire immune system “boosted”? The structure/function claim was the loophole supplement companies were looking for.
The consequences of DSHEA
Although DSHEA protects the consumer right to access products from nature, the costs may be too great. The specifics of the act and the way in which industry and the public has responded, has led to several problems:
1. Supplements are perceived as safe when in fact they are not. There are 23,000 ER visits per year in the US due to supplements and 20% of drug induced liver injury is caused by supplements. This is only the tip of the iceberg because side effects are not formally tracked.
2. Supplements are perceived as being able to prevent and treat disease. Some companies make specific disease claims breaking the law while others use the ambiguous nature of structure/function claims to their advantage. Consumer confidence is confirmed by public surveys and financial statements - we spend $38 billion per year on supplements in the US, and growing.
4. The quality of supplements is poor. DSHEA has no requirements for quality control nor has it any punitive measures for poor quality. Without quality control, products can contain anything. This probably explains why 50% of supplements sampled on shelves contain none of the ingredients on the label. In addition, some supplements are ironically tainted with prescription drugs. (see FDA site listing known tainted supplements for weight loss ).
4. Private research on natural medications has stagnated. Companies are no longer required to prove safety and effectiveness. They rarely spend money on good clinical trials. Instead, they spend money on marketing the loopholes of DSHEA. So we don’t know that much more about the true safety and effectiveness of these natural medications today than the day DSHEA was passed in 1994.
5. DSHEA promotes unscientific thinking. In particular, the appeal to nature fallacy: if something is natural it is safe, if it is unnatural it is unsafe. This leads to the public’s misunderstanding of science.
6. DSHEA leads to a negative perception of drugs. If supplements are safe and effective, why use synthetic drugs with all their side effects? White Willow bark has the same active ingredient as Aspirin; yet, only Aspirin is forced to be adorned with warning labels.
Conclusion
DSHEA is responsible for officially separating medicinal compounds into supplements and drugs in the US. It has done so primarily based on regulation, ownership and patentability - creating a misleading dichotomy. It’s consequences include: a false belief that supplements are effective and safe, an increase in the usage of unsafe and ineffective supplements, poor supplement quality, a stagnation of private research, and the promotion of unscientific thinking.
Biologically, there is no difference between a supplement and a drug. It does not matter whether a medication is regulated or unregulated, patentable or unpatentable, natural or synthetic. What matters is if it works. There is no “supplement” form of medication. There is only medications that work or medications that do not work.