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What does "No approved therapeutic claims" actually means?
I've seen this label on the packages of cosmetics and food supplements. Just what does it actually mean?

William T
This sentence is put on alternative medicines to warn people that, legally, it is not medicine and nothing that it claims to do has been proven by science.

It means that the manufacturer can't say that the product helps or cures any condition. The FDA doesn't regulate nondrug supplements, so you get meaningless language like "supports healthy digestion", with the logic that a drop of water in the desert "supports" good hydration.

As for this language being dismissively called "legalese" by someone who as far as I know has never been a lawyer in this or any other lifetime, speaking as a lawyer, I can say that there is a good reason for these disclaimers.

Caveat emptor.

It means the FDA has done no studies to determine the efficacy of this pill/herb/whatever in actually treating anything. It's not proven to be effective. It's a disclaimer of sorts.

therapeutic claim mean is having a good effect on the body or mind.

Hello,, I think it means you cannot use a prescription drug card to help pay for it. The insurance scamming bureaucrats don't approve of it's use.

MOst certainly like budygil have answered

It means no matter what they say there is no proof that it will do what it says. In other words, don't take me to court because I told you it wasn't approved right here on this label.

Every single person who posted before me, except for David, is WRONG. The language means the FDA has not authorized the manufacturer to make any claims or statements about the product's efficacy or statistical claims for how well it works or doesn't. It doesn't mean it won't work, or doesn't work. It just means the company cannot LEGALLY make any claims about the product. It is ALL strictly legalese and almost means nothing, b/c even allopathic doctors recognize the efficacy of vitamins and minerals and some herb, and prescribe them. I've been prescribed both Vitamin E, and niacin and calcium, magnesium and manganese before as well as mulitiple rare earths like vanadium and germaninum in the treatment of my diabetes and circulation issues as a result of being heterozygously positive for Factor V Leiden Clotting Disorder, and in the potential preventative treatment of the heart disease that can result from being diabetic. Hell, prior to about 1948, more than 50%, of the US Pharmacopeia was herbal or mineral in origin. Prior to about 1880-1900, 80% of the US Pharmacopeia was herbal or mineral in composition/origin. Hope this is all clear.

David S
In the US, Dietary supplements are sold under the Dietary Supplement Health and Education Act of 1994. They are intended to provide nutrition but are not sold for "medicinal use."

For example, a Vitamin C supplement is intended to provide your body with Vitamin C. Even though a Nobel Prize was award for the proof that Vitamin C cures and prevents the disease called Scurvy, no Vitamin C vendor is allowed to put any mention of that on the bottle or in their product literature.

It has nothing to do with proof.

It is entirely an issue of legal framework.

This legal framework was put in place by unanimous vote from both houses of Congress in response to the massive abuse of power the FDA was exhibiting just prior to the passage of this law (read the Congressional transcripts to see what people from the FDA were doing to trample on your rights to have access to dietary supplements.)

Another example: In last month's issue of the Lancent, a major study was published on Echinacea. In this study of a standardized extract of the whole plant (meaning the 300+ phytochemicals were tested as a whole instead of the single molecule extract that US studies usually focus on) Echinacea was found to cut the duration of a cold by over 50%. Anyone who make Echinacea cannot inform you of that because it would be considered an illegal therapeutic claim of their product. Under the DSHEA Act framework though, you have the legal right to read that study and then seek out Echinacea for your own use.

Incidentally, the FDA is not responsible for drug testing. In 1981, Ronald Regan moved drug testing from the NIH (it's never been the FDA) to the drug companies. They write their own tests and provide the results to the FDA for approval of their drugs. Included in that data is the known lethal dose of the drug. ALL drugs are poison and a lethal dosage must be established, or it can't be approved as a drug.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed by unanimous consent of both Houses of Congress to ensure your right to access safe and efficacious dietary supplements. They gave the FDA the mandate to allow this access, and ensure the products were safe and made in a consistent manner. Last year, the FDA finally passed rules to require “Adverse Event Reporting” which means supplement companies are required to track safety data and now the new rules have finally been passed for Good Manufacturing Practices. This means that supplements must be made to standardized quality to ensure that you are getting consistent products.

These new rules are to your benefit and are a complete opposite of the specific actions top level people at the FDA were conducting to eliminate your ability access dietary supplements prior to the passage of DSHEA. The result might be what seems to be confusing legal mumbo-jumbo, but without this legal framework, your rights would not be protected and you'd have no choice except for what the drug companies sell.

It means that the product has not been tested for any therapeutic benefits.

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