Is it legal to use supplements to treat disease? The FDA explains:

[HysteryDiagnosis]

Please keep in mind that in Europe the first thing a heart attack patient is prescribed is 1000mg of omega threes/day. In Italy you can go after your doctor for not prescribing them. I assume that they are covered by health inscos. "over there" where the sickly live.


http://www.fda.gov/food/dietarysupplements/consumerinformation/ucm110417.htm

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?

No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.
Who validates claims and what kinds of claims can be made on dietary supplement labels?

FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.

By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail.
Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
How are advertisements for dietary supplements regulated?

The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to the FTC web site. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.

[MineralMan]

1. Doctors here can prescribe the same thing, if they wish.

Or, they can advise their patients to take an over-the-counter supplement. Many do so, including my own physician. I follow his advice.

If a doctor prescribes an Omega-3 supplement, the patient can take it to the pharmacy counter, and the pharmacist will fill the prescription with an Omega 3 supplement from a big bottle of capsules, manufactured by a trusted supplier. Right now, the only FDA-approved prescription Omega-3 preparation is Lovaza. The company who makes that Omega-3 supplement has gone through the FDA's testing and trial procedure to gain that approval. The pharmacist will charge the customer more for that supplement than it would cost to buy one from the shelves next to the pharmacy counter. So, the pharmacist may recommend that the customer buy the over-the-counter supplement after consulting their physician.

If the patient is in the hospital, and the doctor prescribes an Omega-3 supplement, the hospital pharmacy will fill that prescription and it will come to the patient through the patient's nurse, when medications are given.

The supplement makers are free to sell Omega-3 supplements as they wish, but not to advertise them as a treatment or cure for anything. The FDA and FTC regulations are perfectly fine. Most physicians who want their patients to take an Omega-3 supplement will tell the patient to do that and the patient will purchase an over-the-counter product, made my one of the supplement manufacturers, and packaged as a brand-name product, like the Nature Made supplements you find at every drugstore these days.

But make no mistake, any physician can prescribe Omega-3 supplements in the United States, and many do. So, yes, it is legal for physicians to prescribe supplements to treat a disease. What is not legal is for companies to do so in their advertising. That's the difference.

[emcguffie]

2. But if it is available as a supplement, insurance won't cover it.

I have chronic health problems, but cannot afford to take most of the supplements that might do me some good. Many of them cost around $30 a month, which is way too much for me. I buy what is affordable at Costco -- like vitamin D. My husband gets his omegas there.

Of course, if our beef was raised naturally, we would have been getting omega 3's that way all these years. When they are grass fed, so I've been told, they produce omega 3's.

[MineralMan]

3. That, I have no answer for.

Fixing that will take a complete overhaul of our healthcare system. I support a single-payer tax-funded healthcare system, and have for years. How supplements would be handled in such a system, I have no idea. My wife and I buy our supplements at Costco, too. On the other hand, the co-pays for our prescription medications are an additional cost.

[uppityperson]

4. They also can, and often do, prescribe aspirin but insurance won't cover that either

Or, if they do, it costs more than simply buying baby aspirin OTC. Many OTC things are either not covered by insurance or at an additional cost. Not all, but many. Like asa and omega 3 oil

[laconicsax]

5. It all has to do with factual claims.

If a supplement manufacturer wants to market their product as a cure for whatever, then they need to play by the same rules as the pharmaceuticals. If they do the studies to show that their product is 1)effective and 2)safe, then they shouldn't have any problem having their statements "evaluated by the FDA."

Of course, they'd be held to stricter production quality and labeling standards and also have to pass clinical trials...