Jul 11 2016

Former FDA Directors Criticize Supplement Regulation

fda1Recently six former directors of the Food and Drug Administration (FDA) met in Aspen to talk about the FDA. According to reports much of their criticism for their former agency was focused on lax regulations for supplements.

I, too, have been a consistent critic of how supplement are regulated in the US and elsewhere. Currently the regulation is determines by the 1994 Dietary Supplement Health and Education Act (DSHEA). This law passed while David Kessler was commissioner of the FDA, a law he vigorous opposed.

The Atlantic reports:

Jane Henney, commissioner from 1998 to 2001, recalled that the DSHEA law actually passed in the wake of the FDA “really trying to get their arms around stronger regulatory authority with dietary supplements.” This attempt at requiring supplement producers to guarantee the quality and safety of their product was countered by one of the most intense lobbying campaigns in history, in which TV commercials warned citizens that the government was coming for their vitamins. “I believe that the amount the Congress heard about this whole issue was greater than what they received about the Vietnam war,” she said. ‘I mean, it was tremendous.”

By all accounts this was a clear case of an industry lobbying the government in order to pass regulation friendly to industry and against the interests of the public. They were successful for a few reasons.

First, they had senator Orin Hatch in their pocket. He is a senator from Utah, which is the home of the supplement industry – they are perhaps his most powerful constituent. He had help from across the isle, from senator Tom Harkin, who is a true believer in supplements.

Second, they engaged in a very successful propaganda campaign. In fact, they had been waging that campaign for decades and now they are reaping the benefits. They have successfully created a health halo around anything deemed a “supplement.” This is partly based on the health halo around anything labeled “natural.” Most people just take it for granted that natural things are safe and healthy.

Even when the FDA simply tried to clarify what constitutes a disease claim (something not allowed for a supplement under DSHEA), they received 100,000 letters from the supplement industry and their allies opposing these common sense rules.

In the end we essentially have a situation where an industry was allowed to write their own regulation, one that allows them to sell health products to the public, with clear health claims, without any burden for providing evidence that their products are safe, their health claims are reasonable, or even that what is on the label is in the bottle.

Essentially there is almost no regulation of supplements. The FDA can try to get a product pulled if they prove it is harmful. So far, they have done this with one supplement, ephedra, which was causing people to drop dead at a rate of about 7 per year. They can also get involved if supplements are adulterated with actual drugs, because they can regulate drugs. They have some minor oversight over manufacturing. That’s it.

Compare this situation to that of GMOs. Here we have an industry that is tightly regulated, and has to provide significant evidence of safety prior to market. And yet we have people screaming that the agricultural industry is not being regulated enough, and they are in bed with the FDA, EPA, and USDA. In this case the propaganda is produced by the organic food industry – also a multi-billion dollar industry ripping off the public based on the appeal to nature fallacy.

Regarding the supplement industry:

The global market for these products was $82 billion as of 2013, with the U.S. accounting for more than a quarter of that. Sales increased by $6 billion between 2007 and 2012.

Whenever you have billions of dollars on the table, there is a huge motivation engage in marketing to influence public opinion and to lobby the government for friendly regulations. That’s why we need consumer advocates.

What is curious is the fact that consumer advocates seem to be completely MIA when it comes to the supplement industry.

The result is supplements that are often contaminated, adulterated, and often don’t even contain the ingredients listed on the label. You can essentially put anything (other than an actual drug) in a bottle, make whatever health claims you want (just don’t mention a specific disease by name) and sell it, without any burden of showing quality, safety, or backing your claims.

The bar for entry into the supplement industry is therefore very low, and the profits high, and so the industry has exploded. What is the public getting for their $82 billion dollars a year and growing? Probably not a single thing. A tiny slice of these sales are probably going to evidence-based actual vitamin and mineral supplementation. The rest are going to unnecessary supplementation and herbal drugs sold as supplements.

It is a massive waste, and a con on the consumer.

All of the FDA commissioners share frustration over the fact that they simply did not have the authority from Congress to do their job and meet their mandate of protecting the public health.

You might argue that the public gets the regulations they want, but the public is largely unaware of how lax these regulations are. They assume that claims and products are reasonably regulated, and they are simply wrong.


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