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Dietary Supplement Disclaimer
Deregulating the Dietary Supplement Industry
During the 1990’s, intense lobbying by the dietary supplement industry resulted in the United States Congress passing the Dietary Supplement Health and Education Act of 1994 (DSHEA).
DSHEA made dietary supplement manufacturer responsible for ensuring their supplements were safe before they are marketed. Unlike prescription drugs that can not be sold without FDA approval, under DSHEA the FDA is responsible for taking action against any unsafe dietary supplement after it reaches the market.
Dietary supplement manufacturers do not need to register their products with the FDA nor get FDA approval before producing or selling them. Manufacturers are not required to prove their products work, but must assure product label information is truthful and not misleading. To that end manufactures can state, based on published clinical studies, a product may lower cholesterol or decrease joint pain but they cannot claim the products will cure the a disease or condition. Dietary supplement claims claim to cure diseases or reduce cholesterol becomes a drug requiring FDA approval.
FDAs Post-Marketing Responsibilities
The FDA’s post-marketing responsibilities include monitoring the safety of dietary supplements or as they put it “voluntary dietary supplement adverse event reporting.” In plain English, the FDA monitors reports of adverse side affects from taking dietary supplements (heart attacks, stroke, liver and kidney failure, nerve damage, death) and takes appropriate action when necessary including banning the product. The FDA also monitors product information, such as labeling, claims, package inserts, and accompanying literature.
Claims made by manufacturers of diet supplements in television and radio ads also come under the jurisdiction of the FTC. If the FTC rules advertising claim or claims are misleading or deceptive, they have the authority to fine the manufacturer and order them to stop making the misleading or deceptive claims.
Usually a manufacturer will admit no wrong doing and stop making the claims. Occasionally, a State Attorney General may do the same after substantiating complaints filed against a supplement manufacturer. What you have is an unregulated industry policing itself. With continuing budget cuts, neither the FDA nor the FTC has sufficient funding to police the industry’s claims and rely on consumer complaints to protect the public from unsafe products. There is a growing movement to grant the FDA authority to regulate the diet supplement industry. Even if the FDA is given authority, it must have the budget and people to monitor the industry.
Claims sounding too good to be true probably are. Avoid products with the following disclaimers:
“Results not typical”
“Diet and exercise required to lose weight”
“When used with ANY sensible diet and exercise program”
“Based on an 8 week study”
If ad testimonials claiming miraculous results are true, why do the ads have so many disclaimers? Because most testimonials and claims do not represent typical results and in some cases are completely false. If the product produces dramatic weight loss without increasing physical activity why do you need a sensible diet and exercise program? The ads do not say with “any sensible diet or exercise program.” They also do not define what is meant by “sensible.” If you take the supplement while on a diet and exercise program and lose weight how do you know what caused the weight loss? Was it the supplement, the diet, the exercise program or all three?
No Dietary Supplement Has Been Proven To Cause Weight Loss
Supplement makers want people to believe their products are inexpensive, nonsurgical solutions for weight loss, but no dietary supplement is equivalent to gastric bypass, Lap-Band® or other surgical procedures proven to curb appetite and produce weight loss.
Clues to diet ad claims stretching the truth include:
- References to unnamed doctors or universities
- Unnamed or unpublished research studies
- Claims diet and exercise are not required to lose weight
- Fine print research studies “suggest” the statements in the ads are factual
- Young, attractive male and female models with defined muscles
- Before photos that look like drivers license photos and Hollywood style after photos (note the difference in hair style, posture and makeup in the after photos)
- 2-page ads with 8-point or smaller text praising the product
- Ads resembling newspaper or magazine articles labeled “Special Advertising Supplement”
Added November 2014
Despite millions of dollars used to advertise dietary supplements and their claims to cure just about every condition under the sun, there is growing evidence that most supplement (vitamins, minerals, and herbal) are ineffective. Clinical studies are confirming whole, minimally processed foods are the best source of vitamins, minerals, antioxidants, and other nutrients that reduce or prevent diseases.
Don’t expect supplements to disappear from store shelves any time soon. Multi-billion dollar industries have a lot of political clout. As long as people believe a pill will reduce their risk of diseases or cure their illness there will be a thriving market for supplements.