Earlier this month, FDA issued draft guidance addressing substantial equivalence of new tobacco products. In doing so, FDA provided tobacco manufacturers with much needed guidance on FDA’s “current thinking” on this subject. Comments on the draft guidance are due by November 8, 2011.
Second Warnings Suit Filed Against FDA by Big Tobacco
Posted in FDA, Significant Cases
In early July, we reported that the four leading tobacco companies were threatening legal action against the Food and Drug Administration (FDA) over the nine new graphic cigarette health warnings that must appear on each cigarette package beginning in September 2012.
What is an Unacceptable Tobacco Brand Name Sponsorship Under FDA’s Regulations?
Posted in FDA
Effective June 2010, FDA issued advertising and marketing restrictions under the Tobacco Control Act. Among those requirements is a provision prohibiting tobacco manufacturers, distributors and retailers from “sponsoring” any “athletic, musical, artistic, or other social or cultural event, or any entry or team in any event” in the brand name, logo or selling message of any cigarette or smokeless tobacco brand.”
FDA Offers Two New Opportunities for Public Comment
Posted in FDA
The Food and Drug Administration (FDA) has recently opened a new docket for public comment on Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke.
FDA to Begin Inspecting Tobacco Product Manufacturers in October
Posted in FDA
In a letter to the industry dated August 16, 2011, the FDA announced that it will begin inspecting every factory engaged in the manufacture or processing of cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The inspections will begin in October 2011, and pursuant to the Tobacco Control Act, inspections will be conducted at least once every two years.
TPSAC Evaluates Dissolvables
Posted in FDA
On the heels of FDA’s surprising determination that dissolvable tobacco products, such as Star Scientific’s Stonewall and Ariva and R.J. Reynolds’ Camel “Orbs,” are not considered smokeless tobacco products currently subject to regulation under the Tobacco Control Act, the FDA’s Tobacco Products Scientific Advisory Committee convened its first meeting to evaluate these products.
One Issue Resolved, but Many New Issues Remain
Posted in FDA
At least one issue is resolved. The Food & Drug Administration (“FDA”) will regulate electronic cigarettes (“e-cigarettes”) as tobacco products and not as drug-delivery devices. Yet, many other issues remain unresolved as a result of the FDA’s decision, including the taxation of e-cigarettes.
FDA Issues Draft Guidance on Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
Posted in FDA, State Regulatory
FDA recently issued draft guidance regarding how a manufacturer can establish that its tobacco product was commercially marketed in the United States as of February 15, 2007, thus exempting the product from the onerous premarket requirements of the Tobacco Control Act (“TCA”). The guidance first explains that FDA interprets the phrase “as of February 15, 2007” as meaning that a tobacco product was commercially marketed – not in test markets – in the United States on February 15, 2007.
Current Good Manufacturing Practices — An Overlooked Requirement with Far Reaching Consequences
Posted in FDA
A significant provision of the Family Smoking Prevention and Tobacco Control Act is the requirement for tobacco manufacturers to operate in compliance with current good manufacturing practices (cGMP). One good approach to understanding these requirements is to read the underlying regulations. For finished pharmaceuticals this is 21 CFR Part 211.
FDA Issues “Guidance” on Exemptions from Substantial Equivalence Requirements
Posted in FDA
On July 29, 2011, FDA issued a final rule to establish procedures for requesting exemptions from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act. Unfortunately, despite the vague statutory language regarding such exemptions, and numerous industry requests for more clarity regarding such exemptions, the final rule provided almost no guidance.