Source: https://www.casewatch.net/fdawarning/prod/2013/star_scientific.shtml
Timestamp: 2019-04-26 02:13:32+00:00

Document:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites in December 2013 and has determined that you take orders for the product Anatabloc at www.anatabloc.com. This website, along with another website that you also operate, www.starscientific.com, promotes the product Anatabloc for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on these websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.
In addition, your Anatabloc and CigRx products contain anatabine as a dietary ingredient. While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket notification. To date, a premarket notification has not submitted to FDA, for your products containing anatabine; therefore, they are deemed to be adulterated. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Your websites claim that Antabloc is a dietary supplement. Under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)], a dietary supplement may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its investigation was authorized. According to your product labeling, your Anatabloc product contains anatabine. Anatabine became authorized for investigation as a new drug under an investigational new drug application (IND) that went into effect on June 8, 2012. According to press releases on your www.starscientific.com website, you began marketing CigRx, containing anatabine, on August 5, 2010, followed by Anatabloc, also containing anatabine, on August 11, 2011. Although these products were labeled and promoted as dietary supplements, they were not legally marketed as dietary supplements before the authorization of the IND because the products were adulterated due to the presence of anatabine, a new dietary ingredient that fails to meet the requirements of the Act, as explained below.
A dietary ingredient that was not marketed in the United States before October 15, 1994, is a new dietary ingredient under section 413(d) of the Act [21 U.S.C. § 350b(d)]. To the best of FDA’s knowledge, there is no information demonstrating that anatabine was marketed as a dietary ingredient in the United States before October 15, 1994. Therefore, anatabine would be a new dietary ingredient.
2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
Because the required premarket notification was not submitted to FDA, your products containing anatabine are deemed to be adulterated under section 413(a) of the Act and are prohibited from being marketed in the United States under sections 301(a) and (v) of the Act [21 U.S.C. §§ 331(a) and (v)]. Your unlawful marketing of the anatabine-containing products, CigRx and Anatabloc, does not constitute “market[ing] as a dietary supplement” within the meaning of section 201(ff)(3)(B) of the Act, and therefore these products were not legally marketed as a dietary supplement before the investigation of the new dietary ingredient they contain, antabine, was authorized under an IND.
To the best of FDA’s knowledge, there is no information demonstrating that anatabine was marketed as a food prior to being authorized for investigation as a new drug under an IND. Although anatabine occurs naturally in certain foods such as cauliflower, eggplant, potatoes, and tomatoes, the mere presence of anatabine in such foods, without any evidence that the foods were promoted for their anatabine content, does not constitute “marketing” of anatabine as a food under section 201(ff)(3)(B). See Pharmanex v. Shalala, No. 2:97CV262K, 2001 U.S. Dist. LEXIS 4598 at *14-15 (D. Utah, March 30, 2001). Because anatabine was not lawfully marketed as a dietary supplement or as a food before it was authorized for investigation as a new drug, your Anatabloc product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the Act because it contains anatabine.
Further, based on statements on your website www.anatabloc.com that anatabine is one of the alkaloids found in tobacco and that anatabine has been shown to have anti-inflammatory effects in human epidemiological studies of tobacco alkaloid exposures, it appears that anatabine can be manufactured from tobacco. It is important to note that tobacco, including its constituents, is excluded from the definition of “dietary supplement” under section 201(ff)(1) of the Act.
Your Anatabloc product is promoted for conditions which cause this product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The claims on your websites establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of claims on your blog at www.anatabloc.com/category/health-research that provide evidence that your product Anatabloc is intended for use as a drug include the claims below. These claims also appear on your webpage “Newsroom-Press Releases” on your www.starscientific.com website.
Your product Anatabloc is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Examples of additional claims on your “Press Release – 2012 Archives” webpage of your website www.starscientific.com that provide evidence that Anatabloc is intended for use as a drug are provided below. These articles also are available via a link on your webpage http://anatabloc.com/category/health-research/.
Finally, your “News/Articles” webpage www.starscientific.com/news-new-articles includes a link to an article entitled “Some Clues to the Prevention and Treatment of TBI,” which further discusses the Roskamp Institute’s research on anatabine and contains statements suggesting that anatabine may be useful in preventing and treating traumatic brain injury. Examples of these statements are provided below. Your use of this article to promote your product Anatabloc is further evidence that Anatabloc is intended for use as a drug.
Your product Anatabloc is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
In addition to the violations listed above, we offer the following comment regarding customer testimonials. In August 2013, we reviewed your website www.anatabloctrial.com, which now redirects to www.anatabloc.com, but which formerly offered free samples of Anatabloc to consumers who filled out an online form. In addition, the www.anatabloctrial.com website included a series of customer testimonials regarding purported benefits of Anatabloc in treating or preventing various diseases. For example, one testimonial stated: “Began taking anatabine because of its antidepressant quality, and it is good at that, for those who may need it…[W]ithin hours my lifelong severe sinusitis began clearing up…Next day I noticed a difference in my asthma (about 50% improved long term).” We note that the webpage containing the testimonials remains available on the Web at www.anatabloctrial.com/assets/anatabloc/testimonial.html, although this page no longer links to www.anatabloc.com. Like direct claims, testimonials on a manufacturer or distributor’s website recommending or describing the use of a product such as Anatabloc for the cure, mitigation, treatment, or prevention of disease are evidence of the product’s intended use as a drug. We advise you to review all websites you operate and remove any testimonials promoting your products for disease uses.
Your written response should be directed to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), Division of Enforcement, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions regarding this letter, please contact Ms. Robinson at 240-402-1890 or by email at Latasha.Robinson@fda.hhs.gov.

References: § 321
 § 321
 § 350
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 § 321
 § 321
 § 355
 § 331
 § 352
 § 331