An FDA First Adds To Rock Creek’s Regulatory Adventures
This article was originally published in The Tan Sheet
Executive Summary
FDA “for the first time” notified tobacco retailers about products found to be not substantially equivalent for sale, with each of the 16 warnings identifying Rock Creek’s Ariva and Stonewall Jackson nicotine lozenges. The firm continues turning its operations to drug development after FDA rejected a NDI notification.
Rock Creek Pharmaceuticals Inc. could be reminded of Rodney Dangerfield’s timeless “no respect” line. After its nutritional supplement business ends when FDA rejects its new dietary ingredient notification, the agency’s first-ever “not substantially equivalent” tobacco product warnings mention its brands.
FDA’s Center for Tobacco Products on Nov. 18 announced that “for the first time” it notified tobacco retailers that inspectors found for sale products not substantially equivalent. Each of the 16 warnings, submitted to retailers in the Southeast and Midwest U.S., identified the violative products as Ariva and Stonewall Jackson dissolvable tobacco lozenges, which Rock Creek made and marketed during its previous incarnation as Star Scientific Inc.
The Family Smoking Prevention and Tobacco Control Act allowed products immediately subject to FDA’s regulatory authority – conventional cigarettes, loose tobacco and smokeless tobacco – that were available in the U.S. as of Feb. 15, 2007, to remain on the market without FDA approval.
However, products introduced after the grandfather date must gain FDA’s pre-market approval by being shown to be substantially equivalent to a legacy product, or through a premarket tobacco product application showing a product is appropriate for protection of the public health; its manufacturing methods, facilities or controls are compliant; and its proposed labeling is accurate.
Additionally, FDA can allow substantial equivalence exemptions for products otherwise substantially equivalent to a grandfathered product except for “a minor modification” of adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive.
CTP in June 2013 made its first and so far only substantial equivalence authorizations, approving two tobacco products. Rock Creek’s products are not among those with a substantial-equivalence marketing OK from CTP.
Supplement Business End Cuts Costs
Rock Creek in September 2014, following FDA’s decision on its NDI notification, announced it would no longer market dietary supplements and cosmetic products in the U.S. and “is primarily focused on drug development” for anatabine citrate. The Sarasota, Fla.-based firm says the ingredient is “cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics.”
After ending its consumer products business, Rock Creek took a third-quarter charge of $3.6 million for inventory, packaging machinery and other assets specifically related to its dietary supplement business. All sales and sales and marketing expenses related to consumer products were reclassified to discontinued operations, a loss of $400,000 for the July-September period, according to its Nov. 10 earnings release.
However, the consumer business loss was $1.5 million in the year-ago period and trimming $1.1 million from the loss came from stopping for its CigRx and Anatabloc supplements after FDA in December 2013 warned the firm about violative inflammation claims for the products.
FDA advised Rock Creek it would not accept its anatabine citrate NDI notification because it is intended to provide inflammation relief, which the agency considers a drug state, and because the ingredient is the subject of a previously filed investigational new drug application. FDA will not file NDI notifications for ingredients that it considers drugs or if an IND application was filed for the ingredient prior to it being legally marketed as a supplement or in food (Also see "Between A Rock Creek And A Hard Place: Firm Stops Supplement Sales, Weathers Litigation" - Pink Sheet, 15 Aug, 2014.).
Rock Creek absorbed FDA decision on its NDI notification as it also weathered class action filings and stockholder derivative lawsuits filed by investors in addition to riding out the notoriety it received from its connection, while operating as its previous incarnation of Star Scientific Inc., to the federal investigation and subsequent conviction of former Virginia Gov. Bob McDonnell (R) and his wife on corruption and other charges .
The company’s founder and its CEO during its Star Scientific history, Jonnie Williams, resigned in December 2013 as the Department of Justice investigated the firm concerning payments and other support Williams provided to McDonnell and his wife Maureen. Williams was the prosecution’s key witness during the trial, testifying under an agreement with DoJ.