In March 2020, the Food and Drug Administration (FDA) issued temporary guidance documents allowing for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak. Due to that guidance, most consumers and healthcare personnel have been able to obtain hand sanitizer without difficulty. Now the FDA plans to withdraw the temporary guidance on December 31st, 2021. This withdrawal impacts any company manufacturing alcohol-based hand sanitizers under the temporary policies.
Continue Reading FDA’s Withdrawal of Temporary Guidance for Alcohol-Based Hand Sanitizers

Starting in 2024, U.S. consumers are going to start seeing new formulations of yogurt on supermarket shelves. The U.S. Food and Drug Administration (FDA) has released an amended standard of identity for yogurt as part of its Nutrition Innovation Strategy. According to the FDA, the new, modernized standard of identity for yogurt allows for greater innovation and technical advances in yogurt production while maintaining yogurt’s basic nature and essential characteristics.
Continue Reading FDA Amends Yogurt Standard of Identity

Recently, President Biden signed the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. The law adds sesame to the list of major allergens, requiring its disclosure on food labels as an allergen.  Food manufacturers have until January 1, 2023 to add sesame allergen statements to their labels.

Current food labeling regulation allows sesame to be declared as a “natural flavor” or “natural spice.”  This creates uncertainty for consumers allergic to sesame when they review product labels at their local grocery stores.
Continue Reading Foods Soon to Bear Sesame Allergen Labels

The U.S. Food and Drug Administration (FDA) recently released a new action plan designed to further reduce exposure to toxic elements, including heavy metals, from foods for infants and young children. This represents the latest development concerning the widespread focus on the levels of heavy metals in baby food. The action plan, titled “Closer to Zero” highlights four steps that the FDA will take over the next three years to reduce exposure to toxic elements “to as low as possible.”
Continue Reading FDA Issues Action Plan to Reduce Heavy Metals in Foods

On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted over an approximate one year period for undeclared allergen(s).  FDA reported that investigators found similar patterns of recalls in previous years.  According to a Constituent Update accompanying the Warning Letter, FDA has sent eight Warning Letters to companies that have manufactured and distributed foods with undeclared allergens in 2020.

This Warning Letter is significant because it is the first time that FDA has issued a Warning Letter to a retailer for the labeling of allergens.  According to FDA, its action was warranted because the company allegedly “engaged in a pattern of receiving and offering for sale misbranded food products” that contained undeclared allergens over multiple years.  While retail establishments are excluded from certain requirements under the Federal Food Drug and Cosmetic Act, retailers have a responsibility to ensure that food labeled within a store contain accurate allergen declarations as well as have a responsibility to ensure packaged foods under the retailer’s brand also have accurate allergen declarations.  The Warning Letter highlights that a retailer is “responsible for investigating and determining the causes of the violations . . . and for preventing their recurrence or the occurrence of other violations. It is [a retailer’s] responsibility to ensure [the] firm complies with all requirements of federal law and implementing regulations” including when products are relabeled in store.

Over half of the FDA’s 338 recalls in 2020 were associated with allergen labeling issues, according to an analysis by the Food Industry Association.  The FDA considers foods that contain undisclosed allergens as adulterated, and has the authority to take enforcement actions with respect to such products – unless the offending company voluntarily recalls those products first.  With this Warning Letter, FDA is suggesting that food retailers have the responsibility to take proactive steps to ensure food is appropriately labeled for allergens when consumer labeling occurs in store.
Continue Reading FDA Reiterates Importance of Allergen Labeling by Issuing Warning Letter Following Repeated Recalls

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

We have blogged on several occasions, most recently on June 19, 2020, about so-called “meatless meat” statutes – statutes intended to regulate the labeling of products resembling traditional meat or poultry but produced from plant- or lab-based materials. The Food Safety and Inspection Service (FSIS) of the Department of Agriculture has concurrent jurisdiction over such matters along with the FDA, and the agencies are contemplating issuing regulations.

The Harvard Law Animal Law and Policy Clinic (ALPC) recently asked FSIS to postpone any regulations in the area of lab-based meat until it has a better understanding of the safety of such products and has had an opportunity to review proposed labels.

The idea of lab-based meat was first bruited in 1930. The first patent for such a product was awarded in 1999 and numerous start-ups claim that they are ready, or almost ready, to sell lab-based meat commercially.
Continue Reading Update On Meatless Meat

Last week, the U.S. Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) issued a checklist to assist human and animal food operations during the COVID-19 public health emergency. The checklist is useful for persons growing, harvesting, packing, manufacturing, processing or holding human and animal food regulated by FDA when assessing or

The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak.

The FDA issued two guidance documents to increase the supply of alcohol-based hand sanitizers. The first indicates that FDA will

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