In December 2020, the US Congress voted to pass, and the President signed, the long-awaited Craft Beverage Modernization and Tax Reform Act (“CMBTRA”), making permanent the reduction in the federal excise tax (“FET”) rate paid by distillers.

The CMBTRA was originally signed into law on January 1, 2018 as a two-year tax break for producers,

On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program.  That user fee program was an addition made in the Coronavirus Aid, Relief, and Economic Security (CARES) Act and authorized FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests.

These user fees concern over-the-counter (OTC) monograph drugs, which are nonprescription drugs without an approved new drug application which are governed by the provisions of section 505G of the Federal Food Drug and Cosmetic Act (21 U.S.C. 355h).  Under the new fee schedule, FDA will assess a fee for certain facilities registered with FDA and for the submission of an OTC monograph order request (OMOR).  An OMOR is an industry request for an administrative order to add, remove, or change an OTC drug monograph, which is submitted under section 505G(b)(5) of the Federal Food Drug and Cosmetic Act (21 U.S.C. § 355h(b)(5)).

The announcement took some by surprise, particularly those in the craft distilling industry that shifted production to FDA regulated hand sanitizers, a type of OTC monograph drug, during the COVID-19 public health emergency.  By December 31, 2020, the Department of Health and Human Services (HHS) took action over FDA’s fee schedule.  In a post on Twitter, the HHS Chief of Staff, citing the small businesses who stepped up to provide hand sanitizer in the face of the pandemic, announced that HHS had “directed FDA to cease enforcement of these arbitrary, surprise user fees.”  HHS Office of Public Affairs (Dec. 31, 2020), at https://twitter.com/SpoxHHS/status/1344782160084037639.
Continue Reading Holiday Confusion for the Over-the-Counter Drug Industry: FDA Announces OTC Fee Schedule That HHS Quickly Withdraws

California egg law - carton of eggsOn October 19, 2019, and December 4, 2019, we blogged about the North American Meat Institute’s challenge to California Proposition 12.  Proposition 12 prohibits the sale in California of pork or veal derived from animals confined in conditions that do not comply with the strict California standards.  It builds on the previous ban on the sale of eggs discussed in Association des Eleveurs de Canards et d’Oies du Quebec v. Harris, 870 F.3d 1140 (9th Cir. 2017) (the foie gras case), about which we blogged on May 29, 2018.

As we reported on December 4, 2019, the District Court denied NAMI’s motion for preliminary injunction.  On October 15, 2020, the Ninth Circuit affirmed in a short, per curiam opinion.

The Ninth Circuit panel held that NAMI had presented no evidence that the purpose of the statute was to discriminate against out-of-state businesses.  It also held that Proposition 12 does not have a discriminatory effect because “it treats in-state meat producers the same as out-of-state producers.”
Continue Reading Update on California Proposition 12

The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) has proposed to amend the organic regulations to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. This is one of the largest overhauls since the National Organic Program (NOP) was established.
Continue Reading USDA’s Proposed Rules on Organic Enforcement

We have on several occasions, most recently on February 5, 2020, blogged about so-called “ag gag” laws, statutes designed to prevent undercover investigations of agricultural producers. Since that post, the United States District Court for the Eastern District of Arkansas has dismissed plaintiffs’ challenge to the Arkansas statute for want of standing.
Continue Reading Ag-Gag Law Update

On November 5, 2018, we blogged about the circumstances under which checkoff dues violate the First Amendment.  Such dues are common in the ag sector.  Growers of cattle, for example, pay dues of $1 per head to various organizations that use the money for generic advertising.  These dues are by no means entirely popular with growers.  Large producers can pay hundreds of thousands of dollars a year.  Many growers would prefer to tailor their own advertising rather than relying on generic ads.  Constitutional challenges to the checkoff are not uncommon.
Continue Reading Update on Checkoff Dues

We have blogged on several occasions about the status of “meatless meat” statutes designed to restrict the sale of plant- or lab-based products that look, taste and cook like meat from animals or poultry.  On February 4, 2020, we discussed the appellant’s brief in Turtle Island’s appeal of the District Court’s denial of its motion to enjoin enforcement of Missouri’s meatless meat statute.  The State has now filed its appellee’s brief.
Continue Reading Meatless Meat Update

Companies directly and indirectly regulated by the U.S. Food and Drug Administration (FDA) face specific challenges separate from other businesses in dealing with the recent outbreak of coronavirus disease 2019 (COVID-19).  At the time of this writing, FDA has not offered specific recommendations on measures that regulated industries should take.  However, good manufacturing practice (“GMP”) requirements and the Federal Food, Drug and Cosmetic Act (“FDCA”) impose obligations on regulated industry to monitor and control employee health and sanitation practices as they relate to product quality and safety.  Beyond the risk of state and federal enforcement, there are reputational risks associated with inadequate management of COVID-19.

Continue Reading Coronavirus in FDA-Regulated Industries

We have blogged on several occasions, most recently on February 4, about the so-called “meatless meat” statutes – laws in which states try to protect their agricultural sectors by banning the use of words like “meat” or “chicken” or “burgers” to describe plant-based or lab-grown substitutes.  Three states – Missouri, Mississippi and Arkansas – have passed such statutes and a number of other states are considering doing so.  All of the existing statutes have met with First Amendment challenges.
Continue Reading Meatless Meat Update