More Food For Thought

Almost three years ago I wrote about the widely advertised supplement, Prevagen. The Federal Trade Commission (FTC) challenged the company’s claims about the product’s safety and effectiveness in improving memory. That FTC action followed a number of warning letters to the company from the FDA expressing similar concerns.

Supplements in general cause regulatory headaches for the FDA. “In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise.” (I wonder how many lobbying dollars were spent on that law.) The government may stop a company from selling a supplement if they can prove it “poses a significant risk,” that is, usually “only after they cause harm” to customers. Even then they may face a fight.

Because they are not drugs, rigorously tested for safety and effectiveness, at the end of their advertising they are required by law to carry the disclaimer, “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease." Many get around this by making weak promises such as the supplement reduces the risk of certain health problems or it promotes a healthy condition. 

As far as that one and others that claim to improve memory, the Alzheimer’s Association finds such products, not approved by the FDA to be particularly troubling. “One of the biggest problem areas for unsubstantiated claims are dietary supplements...that claim to be beneficial for Alzheimer’s or other dementia symptoms.” But the promotion of these products and introduction of new ones hasn’t slowed down. “In the past five years, the FDA has issued more than 40 warning letters to companies illegally marketing over 80 products claiming to prevent, treat or cure Alzheimer’s disease.” Furthermore, the FDA recently warned that cognitive enhancement supplements “may be ineffective, unsafe, and could prevent a person from seeking an appropriate diagnosis and treatment.”

Now the problems and dangers surrounding the sale of supplements to prevent memory loss or to improve memory has been raised again in the November issue of JAMA Internal Medicine. A research team tested for the presence of Piracetam, a supposed brain-enhancing substance that “is not approved as a drug and is prohibited as a dietary supplement ingredient in the United States.” They found inconsistent labeling with errors ranging from 85% to 188%. This substance has known adverse effects including: anxiety, insomnia, agitation, depression, drowsiness, and weight gain.

These marketing techniques are truly unconscionable. They make every attempt to prey on older Americans who are already scared at the prospect of contracting some form of dementia by the ads, news stories, shared experiences of friends and personal experience with elderly relatives. Some are concerned about the prospect of mentally fading away. Others worry about being a burden on their family. 

Feelings of anxiety every time a name or fact is not at one’s finger tips make it easy to fall into the trap of buying these unproven products with the hope that maybe it really works. Action of the placebo effect on friends and acquaintances whose minds have fooled them into believing in it compound the problem. But reading and understanding the fine print that follows the ads and knowing that now there's a possibility of some products being adulterated with unapproved drugs should act as sufficient deterrent to critical thinkers.

Making Yourself Smarter Through Drugs

Here is another scam that strikes at the heart of two major worries: the fear of Alzheimer’s disease among older Americans and the competition to be the smartest person in the room among the younger. I wrote a couple of years ago about the troubles faced by the makers of the supplement Prevagen when the advertising overstated its effectiveness as a memory enhancer. Now another product with one name, but multiple formulations and sponsors, has been called out by the FTC for questionable business practices and lack of evidence of effectiveness.

The product is called Geniux and sells for about $50 per bottle. The information gathered from their various websites and infomercials on various networks presents a series of very persuasive claims: 

• Clinical Trials have shown that it “boosts brainpower by up to 89.2% and increases focus by up to 121%.” (Note how the false precision of two-tenths of a percent makes it look like real scientific data. But how do you even measure brainpower?)
• Among other things it is said to use “a scientifically engineered stack of maximum strength nootropics, known as ‘smart drugs,’ to help increase brain activity, mental performance, and vigilance.”
• Presumably because your brain “begins to lose sharpness of memory from as early as [age] 30” you must “take a daily enhancer” to prevent a decline in memory and focus.

There are many other examples of their advertising, shown as exhibits in the legal document, but the FTC concludes: “Defendants’ representations that the Geniux Products improve short and long term memory, increase focus, and increase concentration in users; prevent memory loss and increase short and long term memory in persons experiencing cognitive decline because of age; boost brain power, including by as much as 89.2 percent; increase users’ IQ; or improve users’ speed of information processing are false and/or Defendants did not possess and rely upon a reasonable basis to substantiate those representations.” [Emphasis added.]

In addition, the FTC states that there were “no human clinical studies…demonstrating any efficacy in users, including increasing focus, increasing concentration, boosting brain power, enhancing memory recall, or increasing IQ.” In plain language, there is absolutely no evidence that it works.

Whoops! It looked too good to be true, and it turns out that they have exaggerated just a bit – actually it was enough to get them hauled into court by the Federal government for “deceptively marketed ‘cognitive improvement’ supplements using sham Web sites containing false and unsubstantiated efficacy claims, references to non-existent clinical studies, and fraudulent consumer and celebrity endorsements” and forcing them to agree to a settlement barring such brain boosting claims in the future.

But we all know that wild promises, celebrity endorsements and the use of pseudo-scientific language is all it takes to dupe many Americans. Isn’t it ironic that they spend good money on ineffective brain-boosting supplements when a little critical thinking, using the brain power they already have, would help them avoid the problem.