What does the label (on herbal medicine bottles) "No approved therapeutic c!
Question: I am a fan of herbal medicine but the label "No approved therapeutic claim" puts me in doubt of it's effectiveness.
Answers: I am a fan of herbal medicine but the label "No approved therapeutic claim" puts me in doubt of it's effectiveness.
The No therapeutic claim statement simply means that the company's manufacturer makes no specific claim in it's advertising of any health benefit from using the product. Over the counter drugs, including herbals require the FTC (Federal Trade Commission) approve advertising of any claimed health benefits. (The FDA (Food & Drug Administration) performs this role for prescription drugs.) It does not necessarily mean the product is ineffective. In most cases, the manufacturer does not want to, or cannot meet, the stringent "proof" requirements to back up it's desired advertising claim so they take the easy way out and make no claims at all. If you want more details about the process, you can read the document below.
In order for a company to bring a new drug to the market, they must submit a New Drug Application (NDA) to the FDA for approval to market it for a specific indication or medical use. The first hurdle for approval is the legal requirement for "substantial" evidence of efficacy demonstrated through controlled clinical trials. This standard lies at the heart of the regulatory program for drugs. It means that the clinical experience of doctors, opinion of experts, or testimonials from patients have no weight in this process. The second critical requirement is that the sponsor must prove the drug is safe "by all scientific means applicable." This places the burden on the sponsor to conduct whatever tests may be needed to establish the safety of the drug product.
The legal requirements for safety and efficacy have been interpreted as requiring scientific evidence that the benefits of a drug outweigh the risks and that adequate instructions exist for its safe use. Many approved medications for serious illnesses (i.e. cancer) have severe and even life-threatening side effects.
Advertising and promotion
The FDA reviews and regulates prescription drug advertising and promotion. (Other kinds of advertising, including for over-the- counter drugs, are regulated by the Federal Trade Commission). The drug advertising regulation contains two key requirements. A company may only advertise a drug for the specific indication or medical use for which it was approved. Also, an advertisement must contain "fair balance" between the benefits and risks of a drug.
usually it means that the FDA has not tested its claims to see if there is any truth to it..i could put water in a bottle and tell you it is a cure for cancer and then slap that "claim" on the side
It means the FDA has refused them permission to make any claims to the effectiveness of their products.
And that's because Big Pharma runs the FDA now, and is actively seeking a ban on all natural and holistic products to protect their bottom line.