Modern Day Snake Oil


The other day I was working and the pharmacist that I work with was telling me about an infomercial he had been listening to on the radio.  He went on to describe how this self-proclaimed Dr. of Chiropractic was touting the benefits of 14 different strains of Vitamin C and how each one was of vital importance to your daily living function.  For a fee of how ever much money, he will gladly send you a month supply of the remedy, and if you are not completely overwhelmed with satisfaction he will guarantee to refund your entire purchase!

This sounds like the modern day snake oil salesman.  Someone rides into town on a covered wagon and sets up shop at the town square.  He stands on the back of his wagon proclaiming the benefits of these great items in treating such ailments as pain control, blood pressure, depression, skin health, stomach ailments and even cancer.

In the early 1990’s, Congress set out to put some safety and limitations on the sale of dietary supplements and decrease fraudulent advertising.  The plan was to limit the ability to advertise false claims and restrict the labeling requirements on dietary supplements.  The health and food industry got wind of the impending regulations and created a national scare.  The health-food industry was able to convince the public that it was the plan of Congress to take away their right to purchase vitamins. 

The ensuing deluge of letters to congressmen put a halt to the impending change in laws.  As a compromise, the Dietary Supplement Health & Education Act (DSHEA) of 1994 was passed.  Basically, this means that dietary supplements cannot be advertised with unsubstantiated drug claims listed on the label.  Also, the label needs to contain the statement that the product or ingredient is not intended for the prevention or treatment of disease.

Here are a couple of issues:

·         The dietary supplement law does not exclude herbs, botanicals, metabolites, extracts, amino acids, or any combination of the above.  The original intent was to define dietary supplements as nutrients provided needed to replace nutrients that are missing from the diet.

·         Even though the advertising cannot include cures or treatments, it may include terms such as support (i.e. This item supports a healthy immune system, or this item supports super brain function, etc)

·         Before marketing and selling, the company does not need to get approval from the FDA showing that it does what it says it does.  It is up to the FDA to search for products being marketed, test them, and then force them off the market if they are advertised inappropriately.  This allows for companies to advertise new products however they want.  If they get caught by the FDA, they need to remove it from the market, however; they can then reformulate the packaging and sell it again under a new label.

·         The FDA is not able to take a product off the market that has been proven to be useless, yet not harmful.  A company may still sell it with claims that it “may support certain disease states”.

·         Products that are similar in structure to illicit street drugs may be marketed as dietary supplements without FDA approval.  The product will be on the market until the FDA finds out about it, tests it, and then bans it.

·         The “burden of proof” lies within the FDA, not the manufacturer or advertiser who is selling the dietary supplement.

The Dietary Supplement and Non Prescription Drug Consumer Protection Act was passed in 2006.  Beginning in 2007, manufactures of dietary supplements are required to report any serious adverse reactions or deaths related to their product.  Really!?!?, I can’t believe it took until 2007 for this regulation to come into place. 

This truly is an industry where the BUYER BEWARE motto needs to be in full force. 

“The FDA has never had enough resources to cope with the enormous amount of deception in the supplement and health-food marketplace. DSHEA has made the problem worse. If I were FDA Commissioner, I would drop any pretense of being able to protect the public. Instead, I would announce that unless Congress provides an adequate law, the FDA cannot protect the public from the deceptive marketing of what DSHEA calls dietary supplements.”
http://www.quackwatch.org/02ConsumerProtection/dshea.html

Dietary Supplement Health & Education Act (DSHEA) of 1994 official document
http://ods.od.nih.gov/About/DSHEA_Wording.aspx

Dietary Supplement Health & Education Act (DSHEA) of 1994 Consume Protection Review
http://www.quackwatch.org/02ConsumerProtection/dshea.html

You may also be interested in reading:
Canadian Internet Pharmacy
Generics, the Untold Story
Mail-Fail Order Pharmacy

Thanks
Steve
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