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FDA Issues Draft Guidance on Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007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FDA recently issued draft guidance regarding how a manufacturer can establish that its tobacco product was commercially marketed in the United States as of February 15, 2007, thus exempting the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.
Research Firm’s Study regarding Impact of New Cigarette Label Requirements May Be Flawed
Posted in FDA
A recently completed study by research firm IBISWorld has concluded that the new graphic labels, which were just released by the FDA and include images of rotting teeth and corpses, will result in a decline of less than one percent in overall U.S. tobacco revenues in 2013, the date when the new labels must be used.
Lawsuits Likely Following FDA’s Release of Mandated Graphic Warning Labels
Posted in FDA, Significant Cases
In the wake of the FDA’s release of new graphic cigarette health warnings that must cover the top fifty percent of both the front and rear panels of each cigarette package as of September 2012, the four leading tobacco companies are threatening legal action, claiming the required warnings violate their property and free speech rights.
“Traditional” Cigars to Be Exempt from FDA’s Reach?
Posted in FDA
Proposed legislation would exempt certain cigars from the FDA’s jurisdiction.