Published on May 1st, 20140
Smoking cessation products must be approved by the FDA. So we checked. In an email to TINA.org, a spokeswoman for the FDA said:
Living Well’s SmokeRemedy product is not approved by FDA as a smoking cessation product. To be lawfully marketed as a smoking cessation product, SmokeRemedy must be the subject of an approved New Drug Application or Abbreviated New Drug Application. SmokeRemedy is not exempt from this requirement because it is a homeopathic product.
Homeopathic remedies that make treatment claims and are sold as drugs must follow FDA regulations. The FDA also regulates labeling of over-the-counter homeopathic products. The agency also separately regulates smoking cessation products. What exactly SmokingRemedy means when it says “FDA regulated” is unclear. But what consumers need to know is that the spray would have to be approved by the FDA as a smoking cessation product to be sold as one. It’s not and the FDA went on to say:
If a manufacturer is making cessation or therapeutic claims about a product that is not approved by FDA to make those claims, then they are subject to enforcement action by FDA.
Another red flag, the risk free trial? The company’s fine print states that at the time of purchase “you may have been offered a one time and/or auto-ship plan.” It’s hard to figure out on the site which option you’ve signed up for and you very well might be signing up for a repeated monthly charge on your credit card for a continuing supply of products.
And that brings us to another item that makes us suspicious. If you can quit smoking with just one bottle, why do you need a supply sent each month?