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.