FDA cracks down on supplement claims

[Nullifidian]

http://www.fda.gov/bbs/topics/news/2005/NEW01260.html

FDA Issues Warning Letters to Marketers of Unapproved 'Alternative Hormone Therapies'
Items promoted for treatment or prevention of cancer, heart disease, and osteoporosis

The Food and Drug Administration (FDA) today announced that the agency has taken action against a number of firms marketing unapproved "Alternative Hormone Therapies" because the products these firms are selling are unapproved new drugs that have not been found safe and effective to treat or prevent certain serious or life-threatening diseases or conditions.
FDA issued Warning Letters to 16 dietary supplement and hormone cream marketers who are making unproven claims that tout the benefits of their "alternative hormone therapy" products in treating or preventing serious diseases, including cancer, heart disease, and osteoporosis, and in affecting the structure or function of the body. These alternative therapies are often promoted as "natural" or "safer" treatments that can be used in place of approved hormone treatments. Marketers have 15 days to respond to FDA.
"FDA takes seriously its responsibility to protect consumers from products promoted with unproven claims. It's particularly troublesome when these claims provide false hope to patients with serious or life-threatening conditions," said Margaret O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs.
In the Warning Letters, FDA advises the firms that, under the federal Food, Drug, and Cosmetic Act (FDCA), a product is considered to be a drug if it claims to diagnose, cure, mitigate, treat or prevent disease or, for products other than foods and dietary supplements, if it claims to affect the structure or function of the body. The Warning Letters further state that FDA considers these products to be "new drugs" that require FDA approval before marketing.
Examples of the unproven claims cited in the Warning Letters include:

• reversing osteoporosis-related bone loss and increasing bone density
• reducing, arresting, or inhibiting the growth of cancer cells
• protecting against fibroids, ovarian, and endometrial cancers
• treating various forms of arthritis

The FDA letters also advise the marketers that advertising claims are governed by the FTC Act and other laws enforced by FTC.
As part of the joint effort, FTC is also issuing letters notifying 34 websites that are promoting "alternative hormone therapy" products with similar claims that the FTC is unaware of any competent and reliable scientific evidence to support the claims. As stated in these letters, the FTC Act prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. For more information, visit the FTC website at www.ftc.gov.

####​

FDA Warning Letters
All Natural Pain Relief Inc. (PDF)
Bio-Health HTML PDF
BuyInnovations.com (PDF)
CHS International Research Ltd. (PDF)
ComCore 21 Corporation (PDF)
Greatest Herbs on Earth (PDF)
HMS Crown, Inc. HTML PDF
Healthworks 2000 (PDF)
Healthy Days, Inc. (PDF)
Heba™ Laboratories, LLC (PDF)
Herbal Fields Supplements (PDF)
Nutriteam, Inc. (PDF)
One Life USA HTML PDF
Suzanne's Natural Foods (PDF)
The Way Up (PDF)
Tip Top Vitamins (PDF)

RSS Feed for FDA News Releases [what's this?]

 

[bioman]

Sounds like they're simply doing their jobs here. I've seen a lot of supp companies market things as the "cure for ..." and that is explicitly forbidden by the the supp freedom act.

I have few problems with FDA stopping companies from spouting pure BS. I'd rather them keep themselves busy with that and making sure companies meet their ingredient claims than have them doing all the arbitrary and capricious crap they've been doing lately.

 

[Nullifidian]

Agreed

I don't know about these supplements, for all I know, some of the claims made by these companies could be true.

However, NONE have been proven. Without proof, it is invalid to make your claim. Mind you, the way proof is defined by the FDA is a ridiculously strenous and expensive process; something not even the wealthiest supplement company can afford.

As a result, under the current system, there will NEVER be "proof" that any supplement fulfills any claims whatsoever.

 

[anabolicrhino]

Agreed

I don't know about these supplements, for all I know, some of the claims made by these companies could be true.

However, NONE have been proven. Without proof, it is invalid to make your claim. Mind you, the way proof is defined by the FDA is a ridiculously strenous and expensive process; something not even the wealthiest supplement company can afford.

As a result, under the current system, there will NEVER be "proof" that any supplement fulfills any claims whatsoever.

The reason we have an FDA is because in the early part of the 20th century "snake oil" salesmen were selling cancer "cures" with ingredients like motor oil, saw dust and opium. The FDA remains a nessecary evil/governing body.It's shear size lends itself to cooruption,like all/any ruling entities.I think if you know what's in the product and you want to take it for what ever reason then you should have the right to experiment.Just don't come crying because you don't like the side effects.One of the first things you learn in law school is that you can't really prove anything. You can only convince people that something is true.... Double your IQ or no money back!!!! call me for details...:lol:

 

[Nullifidian]

I'm perfectly aware of the purpose and history of the FDA, it's part of my job to know. I can't tell you how many times we were told the history through various training courses.

And yes it is necessary, however the current incarnation is by no means even close to the best way to do things.