Dannon Takes a $21 Million Dollar Hit for Bogus Health Claims………

Dannon, the makers of Activia yogurt and DanActive drinks, has been fined $21 million dollars by the FTC for deceptive advertisements involving specific health claims. Specifically, they claim that their products can make you poop and keep you from catching a cold or the flu. Not smart. Really not smart. But it doesn’t matter because they will still come out on top.

The FTC has been trying (bless their little hearts) to crack down on misleading claims in advertisements, and I appreciate the effort. Thanks to the emasculation of the FDA by the 1994 Dietary Supplement and Health Education Act (DSHEA), the FTC is the only governmental regulatory body that can put a stop to them. In this case, as the linked article explains, it is likely too little and too late. Dannon has been pushing their products with these bogus claims for years and they are widely accepted by the public. $21 million dollars is a minor slap on the wrist and just the cost of doing business these days.

To catch any readers not familiar with DSHEA up to speed, it fundamentally changed the way that supplements and herbal remedies are regulated, making us all a lot less safe as a result. Post-DSHEA, regulation of the supplement industry, and even the more mainstream over-the-counter medicine industry (they are actually pretty much all the same thing these days), essentially works like old wild west law enforcement. Manufacturers can pretty much do as they please as long as they don’t make specific disease claims, such as that their product cures asthma, and as long as they don’t kill anybody. Well, as long as they don’t kill too many people.

Under DSHEA, the burden of proof for safety, efficacy and label accuracy belongs to the FDA. That may not sound bad but trust me, it is. There are hundreds of new products in this category that come out yearly and the FDA does not have the resources to investigate all of them. So there has to be some kind of triage system in place. A company can package a product, such as a so-called herbal remedy, and as long as they stick to what have come to be known as structure and function claims (“immune support” or “cardiac health”) they won’t be noticed by the FDA. They don’t need any evidence that their product is safe or that it is effective in any way. They don’t have to be honest about what is on the label in regards to ingredients. Nobody is checking on these things. It is an honor system and it has killed people.

Take ephedra for example. Ephedra is an herb that has been used traditionally for things like colds and asthma, as well as for increasing energy and for weight loss. It is understandable that pre-scientific cultures came to associate ephedra with these conditions because it is a potent stimulant. It constricts blood vessels, increases the heart rate and blood pressure, and it opens up airways in the lungs. Because of this effect it was investigated as a potentially beneficial medicine but the side effect profile was rough and better medications were developed. Science-based medical practice had no place for ephedra but it became an increasingly popular component in supplements taken by people desiring improved athletic performance or weight loss. It still isn’t clear whether or not it actually has much of an effect, if any, in regards to those desired outcomes, but it quickly became very clear that it was dangerous.

For years, thousands reports of adverse events came in to the manufacturers of products containing ephedra. These reports included deaths from strokes and heart attacks. These adverse events, including deaths, occurred not only in unhealthy people with risk factors for such outcomes but also in healthy young adults. Finally the FDA decided to step in, and in the late 90’s proposed label warnings. This was met with a campaign by the supplement industry and their lobbyists, as well as the two senators (Hatch and Harkin) responsible for DSHEA in the first place, to put a stop to this. They succeeded and unsuspecting consumers continued to suffer.

Then the tide turned. Additional evidence supporting the FDA concerns about ephedra came along, and public awareness of these concerns and calls for action increased. But it wasn’t until 2004 that the sale of ephedra was made illegal, after many thousands of serious adverse events were uncovered that had been purposefully kept from the FDA by a supplement manufacturer and after a large and expensive meta-analysis was conducted that clearly showed just how dangerous ephedra was. Even this was bitterly contested by the supplement industry but appeals were denied and ephedra remains banned in America.

DSHEA allowed this to happen. If supplements and herbal remedies were regulated like the sloppy drugs that they are, manufacturers of products with ephedra would have needed to provide appropriate evidence that they were safe. The tale of ephedra puts the lie to the fallacy that natural equals safe and should have served as a cautionary tale and impetus to improve the system. It didn’t, so you the consumer must be weary.

This came out today. I’ve read about many cases of adulterated herbs and supplements, usually Viagra spiked male “enhancement” pills, but things are much worse than I thought. Warfarin? Benzos? Damn. And that’s here in America folks.

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