Photo of Azim ChowdhuryPhoto of Eric P. Gotting

On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021)

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Since the Farm Bill of 2018 changed the definition and regulatory status of hemp from an agricultural perspective, confusion and misinformation has been rife on the U.S. Food and Drug Administration (FDA) regulatory status of hemp and its products—including cannabidiol (CBD), a non-psychoactive cannabinoid.  Despite there not being a clear basis for concluding that CBD

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused

Photo of Azim ChowdhuryPhoto of LieAnn T. Van-Tull

On January 8, 2020 FDA published its latest compliance policy guidance, Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (January 2020), which goes into effect in February. Pursuant to the final guidance, beginning February 6, 2020, FDA intends to prioritize enforcement

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In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy to prioritize enforcement of the premarket authorization requirements against non-tobacco flavored e-cigarettes. E-cigarettes on the market

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A coalition of state and national vapor trade associations[1] has moved to intervene in and appeal the District Court for the District of Maryland’s decision in American Academy of Pediatrics, et al. v. FDA, Case No. 8:18-cv-00883, which drastically accelerated the Premarket Tobacco Product Application (PMTA) deadline for vapor products to May 11,

Reposted from Keller and Heckman’s Blog, The Daily Intake

  • Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and

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As previously reported on this blog, earlier this year, the U.S. Consumer Product Safety Commission (CPSC) announced that it was now reading the Child Nicotine Poisoning Prevention Act (CNPPA) to require nicotine e-liquid bottles to meet the “restricted flow requirement” in 16 C.F.R. § 1700.15(d), in addition to having child-resistant closures. A wave of enforcement