Tuesday, March 29, 2011

FDA CTP's Farce “Action” on Star Scientific’s BDL Products: The Non-Smoking Gun – Guest Commentary by Mr. Sandy Hoff (Izof_texas on Yahoo)

The following is a guest commentary offered by Mr. Sandy Hoff. In it, he makes a strong argument that the FDA's Center for Tobacco Products erred in not defining Ariva-BDL and Stonewall-BDL as tobacco products under the Family Smoking Prevention and Tobacco Control Act. Mr. Huff provides strong evidence that the base Ariva product constitutes a tobacco product, as the FDA has clearly stated that it is a smokeless tobacco product. He then argues that since the BDL varieties are made of powdered, although then compressed tobacco, there is no reason they do not also constitute smokeless tobacco products under the law:

Star Scientific's Ariva product (the "non-BDL" form) has been on the market since 2001. Star has always been most forthcoming about the contents of this product. For example, from its 2009 Annual Report, on pages iii and 6 (and numerous other places therein), Star clearly states that the Ariva product is compressed powdered tobacco. This same claim can be found in every annual report since Ariva was introduced in 2001. Any doubt about the notice to the industry and public of this fact can be erased by a search on "Star powdered tobacco."

The BDL products are made in exactly the same way ... the only difference is that Star has fine-tuned it's (patented) process for curing tobacco for low TSNA content so that it can produce tobacco with levels of TSNA that are "undetectable" by current standard methods. In other words, the only difference between the proposed new BDL products and the previous ones is that the cured tobacco that is first powdered and then compressed is lower in TSNA. (The original Ariva product already contained a "low" level of TSNA ... an order of magnitude or more lower than Swedish snus, which has a stellar safety record regarding use and carcinogenic activity.)

It's like a snowball made from "yellow snow.” In Star's new "BDL snowball" the snow is so clean you just can't see the yellow any more.

So here is the "smoking gun" of incompetence for the FDA’s Center for Tobacco Products (FDACTP). The FDA in 2003 ruled that the Ariva product is indeed a "customarily marketed" smokeless tobacco product and therefore FDA could not, at that time, regulate the products because, then, it had no jurisdiction. See this letter from the FDA to the Campaign for Tobacco-Free Kids, declining its petition for FDA to regulate Ariva as a drug or adulterated food.

Quoting from the last page: “Based on the evidence submitted by the petitioners, FDA has determined that Ariva meets the definition of “smokeless tobacco” in the Comprehensive Smokeless Tobacco Health and Education Act because it is made of powdered tobacco “intended to be placed in the oral cavity.” Moreover, FDA believes that, based on the information available to it at this time, it is precluded from asserting jurisdiction over Ariva as currently marketed because it is a “customarily marketed” tobacco product within the meaning of Brown & Williamson.”

Because the BDL products in question are made from powdered, then compressed, tobacco, the FDA’s failure to define these products as “tobacco products” can only be seen as an administrative mistake of monumental proportions.

My feeling is that Star should: (1) sue FDA for a declaratory judgment on this matter; and (2) test market its BDL products in boxes that proclaim: "As safe and good as your mom's spaghetti" ... with pictures of happy, smiling, consuming children on the boxes. The test market should of course be Washington D.C.

Then see how long it takes FDA to figure out that these are indeed smokeless tobacco products.

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