Feb 14 2019

FDA Wants Better Supplement Regulation

It has been 25 years since the 1994 Dietary Supplement Health and Education Act (DSHEA), which reduced the FDA’s power to regulate supplements. Since DSHEA supplements have been regulated like food, not drugs, with no preapproval process. The FDA can only take action after a product is on the market, and they have the burden of proof of either harm or adulteration (for example, by containing actual drugs).

Unsurprisingly:

Since the law was enacted, the industry has grown from 4,000 products and $4 billion a year in sales to as many as 80,000 products and $50 billion in sales, according to the FDA.

There is no evidence that those additional 76,000 products and $46 billion per year have provided any health benefits to the public, and in fact are probably a net health negative. Anything genuinely useful, like prenatal vitamins, or supplements for actual deficiencies, were already available. The new products are mostly snake oil.

The situation is almost comically ridiculous. Herbal supplements are rampant with substitutions, contaminations, and adulterations. But even if the label is accurate, most herbs do not do what is claimed for them. They are simply not medical useful.

When it comes to vitamins, most people simply don’t need them, and taking megadoses was never a good idea. If anything there may be an unintended consequence of using supplements to justify poor habits, like a bad overall diet. In any case – at best routine supplementation is useless. Targeted supplementation based on special needs or laboratory testing is what is appropriate, and that did not require DSHEA.

Then we can throw homeopathy into the mix, which is literally “magic” water with no to negligible active ingredients.

What DSHEA did for the supplement industry, in addition to weakening FDA oversight, is create a special kind of claim called a “structure function” claim. These are pseudo-health claims, such as “supports a positive mood,” or “boost the immune system,” which are not based on scientific evidence, and often are not even really a thing (you can’t just “boost” the immune system). These are a way of strongly implying a health benefit without actually doing it. They are crafted to deceive the public and to blur the lines between legitimate medicine and snake oil.

Further still – supplement manufacturers don’t even have to list their ingredients for the FDA. So often the FDA has no idea what is in products. And pretty much all of the quality control measures are voluntary. This means that the supplement industry has an open licence to regulate itself, to make inherently deceptive claims, and to market health products that range from worthless to harmful, and to do so with no transparency.

So when the FDA said they plan to crack down on the supplement industry, many people who understand what is going on were understandably underwhelmed. The real problem is that the FDA does not have the authority or the resources to properly regulate the supplement industry. DSHEA made sure of that. So now nothing short of new legislation will really address the problem.

What is the FDA planning on doing?

Gottlieb said he plans a “balanced approach” to improve safety, reduce inaccurate claims and encourage industry innovation. For example, the agency plans to create a rapid-response tool to quickly alert the public if a supplement contains an illegal and potentially dangerous ingredient. It intends to streamline the handling of supplements containing prescription drugs such as the generic version of Viagra and to increase enforcement actions.

So, basically nothing. They are going to do what they are already doing – when supplements are adulterated with actual drugs, the FDA has the authority to do something about it. What they generally do is (and I mean this literally) send a strongly worded letter to the manufacturer. That’s it. So I guess they will do this faster. Most of the time the company ignores the warning, to no ill effect.

What about alerting the public? How often do you read FDA alerts about the quality of a supplement or health product? Right.

While I applaud the stated goal of cracking down on an unruly industry, and updating policies that are 25 years out of date, the FDA simply does not have the power or resources to really make a difference. I predict their current efforts will have essentially zero impact on the supplement industry, which will continue to grow and exploit the public with worthless products and misleading claims.

The deeper problem still is the utter lack of political will. There is one line is the statement from Gottlieb that is revealing – he wants to “encourage industry innovation.” That is often the justification given for deregulation, we want to give industry the room to innovate. But what does that mean in the supplement industry? Are supplement manufacturers actually innovating anything useful?

As far as I can tell the answer is a fat “no”. They are not doing useful research, finding new approaches to illness or symptoms, improving health, or doing anything useful. Generally their “innovation” amounts to marketing, and nothing else. They put almost random herbs, vitamins, and minerals into a pill, and then market it with unfounded “structure function” claims. The product Airborne is a classic example. This is marketed as a way to boost your immune system and fight off infection, but it’s just a nonsensical assortment of vitamins without any clinical evidence to back up its claims. But it was formulated by a school teacher, so there’s that.

Most supplements are marketed without any evidence. At best we may get some in house studies, which are scientifically worthless and are just used for marketing. Or, they will save money and just comb the pre-clinical literature to find something with a headline that may superficially relate to their product, and say that supports their health claims. The whole thing is a giant scam from beginning to end.

I feel sorry for the FDA because they are charged with supervising an out-of-control industry without the ability to really fulfill their mandate. This is worse than no regulation, because it creates the false impression to the public that they are being protected from harm or fraud, when they are not. So the FDA saying they will crack down on bad supplements will, if anything, just lead to more false confidence in supplements. Well – the FDA says they will get rid of the bad supplements, so anything left must be good.

In other words, if anything this will have a net negative effects. It will falsely increase public confidence is an essentially unregulated and fraudulent industry. The public is already being bilked out of $50 billion a year, and this will get worse.

Also – “A study published in 2015 in the New England Journal of Medicine estimated 23,000 emergency department visits in the United States every year were attributed to adverse events related to dietary supplements.”

So there is also a societal as well as personal cost associated with using poorly regulated supplements – there is the opportunity cost of $50 billion in health care expenses, and the cost of taking care of the side effects, and the increased cost of taking care of the worsened health outcomes from relying on worthless products. That is a massive externalized cost for the supplement industry.

Thank you DSHEA – 25 years of supplement fraud foisted on the American public.

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