Star Scientific -6%, receives warning letter from FDA on Anatabloc and CigRx

Star Scientific (STSI -6%) acknowledges it received a warning letter on Dec. 20 from the FDA stating "[Y]our Anatabloc and CigRx products contain anatabine [...] Anatabine [...] is also considered a new dietary ingredient, which is subject to premarket approval. To date, a premarket notification has not submitted to FDA; [...] therefore, [Anatabloc and CigRx] are deemed to be adulterated."

The agency continues that Anatabloc has been advertised by Star Scientific on its websites as a drug, which the FDA has "not generally recognized as safe and effective for the [...] referenced uses."  The FDA urges Star Scientific to "take prompt action to correct the violations." Failure "may result in regulatory action without further notice, such as seizure and/or injunction."

Star Scientific is "responding to the letter and has already advised the agency that it intends to work cooperatively to resolve these issues, including undertaking a review of the Company's websites."

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Comments (4)
  • Adaminatree
    , contributor
    Comments (17) | Send Message
    As I look into my crystal ball, I see star scientific hitting the pink sheets and a whole slew of lawsuits in motion.
    31 Dec 2013, 05:16 PM Reply Like
  • rtcatfow
    , contributor
    Comments (49) | Send Message
    Typical of the FDA, that supports Big Pharma, to come up with an attack on a product that works for numerous conditions, which I and others I know can attest to. But most of the people in this country are programmed sheep, that think our government and drug companies have our best interest in mind. Alternatives to conventional treatments are attacked with no mercy, and we are not given a choice as to how to take care of our own health. Obamacare just perpetuates this misguided idea that Big Pharma, the government, etc,. know what's best for us. Let us decide what is right for us, and get out of our lives.
    31 Dec 2013, 08:42 PM Reply Like
  • Patience29
    , contributor
    Comments (230) | Send Message
    This supplement works wonders for my husband, and we both hope it will continue to be available because of that. It is plant-derived, but altered in their patented process to create Anatabine, so the issue appears to be with Star Scientific calling it a drug (rather than a patented-process supplement) and offering it to the public as such without FDA approval, including lack of clinical drug trials. I am whole heartedly pro-herbs and pro-supplements, but it seems they screwed up big time by calling it a drug. Red flag. The FDA was created for the purpose of monitoring substance, testing & regulation of chemical "drugs" before release to the general public. One has to be careful because once you say "cure" or "drug" the FDA will want to know why and for good reason: snake oil salesmen and deaths. I own this stock due to the efficacy of the product, but I'm very worried about this news and for good reason. They overstepped.. perhaps due to overconfidence in their patent win, who knows. Why their legal department wasn't up to the challenge is beyond me and frankly, I've lost confidence in them. Still like the product, however, so hopefully they will get their proverbial act together.
    1 Jan 2014, 10:30 PM Reply Like
  • David Calleo
    , contributor
    Comments (104) | Send Message
    It is NOT an attack as you may think, STAR did not follow the rules of the FDA! Read the entire letter.
    13 Jan 2014, 10:33 PM Reply Like
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