DSHEA to the Rescue!

DSHEA: Dietary Supplement
Health and Education Act
of 1994

On October 25th, 1994, President Bill Clinton signed DSHEA into law thus the Dietary Supplement Health and Education Act of 1994 was born.

It was the first time that such as astute body as the Congress of the United States acknowledged that "there may be a positive relationship between sound dietary practice and good health.

Although further research is needed, there may be a connection between dietary supplement use, reduced health-care expenses and disease prevention".   

The background is that the Food and Drug Administration had always regulated dietary supplements as food.  The focus was on safety, wholesomeness, truth in labeling and the evaluation of the safety of new ingredients.

The effect of DSHEA is that dietary supplements are now controlled under a different set of regulations than
those covering food and drugs. 

What are we talking about anyway?

DSHEA, for the first time, formally defined just what a dietary supplement was.  It was deemed to be:

"a product intended to supplement the diet and contains one or more of vitamins, minerals, herbs or other botanical, amino acids, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of those ingredients;

is intended for ingestion in pill, capsule, tablet or liguid form;

is not represented for use as a conventional food or as the sole item of a meal or diet;

is labeled as a dietary supplement;

and includes products such as an approved new drug, certified
antibiotic, or licensed biologic that was marketed as a dietary
supplement or food before approval, certification, or license
(unless the Secretary of HHS waives this provision)".

Whew, we've really got to get all those lawyers out of Congress.

The Great "Responsibility" Shift!

The big difference is that the supplement manufacturer now carries the responsibility for ensuring that the product is safe before it is marketed.

FDA pointing to manufacturer for responsibility

SUPPLEMENT MANUFACTURER

"Hey, it was safe when it left the factory!"


The FDA doesn't come into the picture until after the product reaches the market.  If a dietary supplement proves to be unsafe after it is being marketed, then the FDA will take action.

Is There Any Such Thing as
a New Dietary Ingredient?

Manufacturers do not have to register their supplement products or get approval before selling their products unless it contains a "new dietary ingredient".  Manufacturers and distributors themselves make the determination whether or not an ingredient is new. 

New ingredients have been a very confusing area since the launching of DSHEA with repeated requests from the supplement industry for the FDA to clarify its position.

The Natural Products Insider did a good job of reporting the current status of the FDA's attempt to clarify the new ingredient issue So far, it is still up in the air.

If it is truly new, meaning that it is not currently in the food supply, then the manufacturer and distributor must demonstrate why the ingredient is reasonably expected to be safe for use in the supplement.

It's All on the Label...Read it!

Labeling requirements for supplements were beefed up under DSHEA.  This has been very helpful in comparing one supplement to another.  As a minimum, dietary supplement labels must include:

  • a descriptive name of the product
  • clear statement that it is a supplement
  • name and place of business of the manufacturer, packer or distributor
  • complete list of ingredients
  • net contents of the product
  • a "Supplement Facts" panel identifying each ingredient in the product
  • an "other ingredient" statement beneath the panel for: the source of the ingredients technical additives (binders, stabilizers, flavoring, etc.)
  • DSHEA strictly governs label information

    Regarding safety, the manufacturer is under no obligation to record, collect, investigate or forward to the FDA reports they receive of injury or adverse effects caused by the supplement. 

    In reality, no responsible manufacturer of supplements would ignore any adverse effects that come to their attention. 

    Even though the FDA does not require the submittal of such information, there is an army of lawyers out there just salivating over the opportunity to file personal injury lawsuits.

    DSHEA and the Dreaded "Cure" Claim

    Here comes the one that gets supplement manufacturers and their independent network marketers in trouble.  It is big-time illegal for a dietary supplement to be promoted on its label, in print, on DVD's, or verbally as a treatment, prevention or cure for a specific disease of condition. 

    Any company or distributor or associate that does so is deemed guilty of selling an illegal (unapproved) drug and faces fines or even
    jail time. 

    Network marketers must be especially diligent during so-called opportunity meetings where testimonials might be presented.

    Foul! Tilt! Dirty Pool! Shame on ABC!

    Back on June 1, 2007 ABCs 20/20 did a real hatchet job on a manufacturer of nutritional supplements based on the science of glycobiology. 

    ABC sent undercover "investigators" into a home opportunity meeting and secretly filmed the event hoping to catch someone making the "cure" claim (who invited those clowns anyway).  It didn't work. 

    Then they did a cut and paste interview with a couple of PhD glycobiology researchers who said exactly what ABC wanted them to say. They trashed the company and its products even through their own research validated that the products did exactly what the company said they did.

    The whole thing was deceptive, dishonest, a blatant attempt at entrapment and exactly what we have come to expect from network news fabricated expose's.  It's a jungle out there, be careful.

    Unfortunately, at last check, it appears that all the links that exposed the sham that ABC aired have been removed.  Wonder where the censorship pressure came from?  

    Websites Aren't Exempt Either

    The FDA also monitors dietary supplement websites and any distributor or associate the puts up a testimonial

    The FDA is looking over your shoulder

    or makes any hint of a cure or treatment will get a nice letter from the FDA.  DO not ignore the letter.  Fix the problem.

    Websites usually present a problem anyway for MLM network marketers.  Most companies selling their goods and services through the direct sales associate channels don't allow personal websites for their product.  Besides keeping on the right side of the FDA, it's a good idea to see what your product manufacturer's position is on websites before you go live.

    The Ubiquitous Disclaimer

    One more warning.  It is OK to make structure or function claims about a dietary supplement.  These are statements about how the supplement affects the structure or function (workings) of the body.

    If such a claim is made, DSHEA requires that it be accompanied by the disclaimer that the FDA has not evaluated the claim and must also include a statement that the product is "not intended to diagnose, treat, cure or prevent any disease".

    After all only an approved drug can make such a claim...should we laugh or cry?

    <p>Bottom line is that if you are in any aspect of the nutritional supplement business, you are in the FDA's sights.  It would be a good idea to join the American Nutriceutial Association (ANA) and take their DSHEA certification course and learn more about how to avoid the mines.


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