To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have been rapidly updating and providing guidance for alcohol manufacturers interested in producing or supplying alcohol for the production of these important products. The below neatly summarizes the key issues surrounding the production of alcohol for use in or production of hand sanitizers for distilled spirts plants (DSPs).
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Alva C. Mather
Alva C. Mather focuses her practice on alcohol beverage and cannabis regulatory and commercial matters. She represents companies in the alcohol beverage industry, including brewers, distillers, wineries, importers and retailers. Additionally, she works with clients in the growing cannabis space and has in-depth knowledge of the evolving legal and regulatory issues facing this industry. Read Alva Mather's full bio.
TTB and FDA Relax Restrictions on the Production of Hand Sanitizers by Alcohol Manufacturers
By Alva C. Mather on
With the increasing pace of the spread of the Coronavirus (COVID-19) and the related emergent need to increase the available supply for hand sanitizer products across the United States, the Alcohol and Tobacco Tax and Trade Bureau (TTB), followed by the Federal Drug Administration (FDA), have relaxed requirements for certain alcohol producers to produce these products without first amending their existing permits or obtaining prior formula approval.
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TTB Relaxes Consignment Sale Restrictions in Wake of Coronavirus Cancellations
By Alva C. Mather on
On Friday, March 13, 2019, in the wake of growing concerns and related mass cancellations of large events all across the United States, the federal Alcohol and Tobacco Tax and Trade Bureau (TTB) announced that it is relaxing federal restrictions on alcoholic beverage returns that might otherwise violate prohibitions associated with consignment sales.
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Florida Federal District Court Rules GRAS Regulation Preempts Florida Statute Criminalizing Ingredient
By Christopher M. Lahiff & Alva C. Mather on
Posted in Food Safety and FDA, Legislation
In an important ruling dismissing a proposed class action, the US District Court for the Southern District of Florida ruled that the US Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) regulation preempts a Florida statute that criminalized adding grains of paradise to liquor. More specifically, the Court in Marrache v. Bacardi USA, Inc., 2020 US Dist. LEXIS 13668 (January 28, 2020), ruled that the Florida statute was preempted because it conflicts with the Federal Food, Drug and Cosmetic Act (FFDCA) and the FDA’s regulations (21 C.F.R. § 182.10) which establish that grains of paradise are GRAS. 2020 US LEXIS 13668, at *4.
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Eighth Circuit Strikes Down Multiple Missouri Alcohol Beverage Advertising Laws
By Alva C. Mather on
In another blow to the constitutionality of alcohol beverage laws, the Court of Appeals for the Eighth Circuit struck down on First Amendment grounds a number of Missouri’s alcohol beverage advertising laws on the basis that Missouri failed to meets it burden to demonstrate that such laws both advanced the state’s substantial interest and were narrowly tailored to achieve that interest.
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EPA Approves Use of 10 Pesticide Products on Hemp
By Alva C. Mather & Noah Feldman Greene on
Posted in Cannabis, Food Safety and FDA
Yesterday, the Environmental Protection Agency (EPA) announced its approval of 10 new pesticides for use on hemp products. EPA’s approval of nine biopesticides and one conventional pesticide provides greater certainty to hemp farmers in time for the 2020 planting season.
The hemp industry awaits further guidance from other federal regulatory agencies.
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USDA Publishes Long-Awaited Interim Regulations Governing the Production of Legalized Hemp
By Alva C. Mather on
Posted in Cannabis, Food Safety and FDA
Yesterday, the United Stated Department of Agriculture (USDA) released its interim final rule setting forth the proposed rules and regulations regarding the production of hemp under the provisions of the Agricultural Improvement Act of 2018, or the “2018 Farm Bill.” As mandated by the 2018 Farm Bill, the proposed regulations outline provisions for both the approval by the USDA of State or Indian Tribe proposed plans as well as the development of its own federal plan for the production of hemp in the absence of an applicable approved State or Tribal program.
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