Food & Hospitality Archives - The National Law Forum

A Holiday Surprise for U.S. Distilleries: TTB Unveils Long-Awaited ‘American Single Malt’ Standard of Identity

Standards of identity and viticultural area designations add significant complexity to the production and labelling of alcoholic beverages. While not exactly a holiday miracle, many distillers are rejoicing over the TTB’s new rule on American whisky (or whiskey) [1].

On Dec. 13, 2024, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued its long-awaited final rule (the “Rule”) that establishes formal definitions for both “American single malt whisky” and “straight American single malt whisky”. In both cases, the TTB is requiring that the base mash or wort for the whiskey be:

1) fermented from 100 percent malted barley produced in the United States;

2) be distilled to 160 proof or less at the same distillery [2] in the United States;

3) be stored and aged in either used, new charred, or new oak barrels no greater than 700 liters (185 gallons);

4) not use any neutral spirits; and

5) not use any coloring, flavorings, or other blending materials with the exception of caramel color (which must be disclosed on the label).

Like other whiskys such as bourbon and rye, a “Straight American single malt whisky” must be aged at least two (2) years. The new Rule is scheduled to be published on Dec. 18, 2024, and takes effect on Jan. 19, 2025.

Notably, the new Rule allows distillers to use a wide range of barrel sizes, and also permits the use of new charred, new uncharred, and used barrels. This may lead to a number of different styles and expressions in the American single malt category and will allow distillers the ability to repurpose for their American single malt whiskys the same barrels they have used for other products. This brings better efficiency and, potentially, lower costs to production.

These new standards of identity help provide clarity to distilleries in Pennsylvania and beyond that are already producing whiskys made from malted barley, and may also help U.S. malt houses[3] that are already working with distilleries to better cross-market the whiskys made with local malt. Likewise, the new Rule preserves the ability of breweries and distilleries to continue to partner on fermenting malt for use in American single malt whisky by not requiring the fermentation (or storage or bottling) to occur at the place of distillation.

It is noteworthy that prior to the adoption of the Rule, many distilleries were producing and labeling products as “American Single Malt” whisky despite the absence of specific standards, and the TTB has previously approved Certificates of Label Approval (COLA) for those products that generally met the definition of a “malt whisky” before the new Rule. Because the new Rule provides additional requirements, the TTB has provided a “transition period” that allows distillers in the U.S. to continue to use the term “American Single malt whisky” or “straight American single malt whisky” for products that met the applicable standards before the new Rule, but only if those products are bottled before Jan. 19, 2030.

Distillers that are currently producing products they intend to market and label as “American Single Malt” should ensure either that those products comply with the new Rule, or that they are bottled prior to Jan. 19, 2030. The new standards will be added to Section 5.143 of the Code of Federal Regulations, which will include the following chart:

While these new standards add new requirements, the new Rule is expected to provide clarity and a boost for producers of American Single Malt. We hope you find a bottle of American Single Malt in your stocking next year!

Endnotes

TTB Regulations allow the use of “whisky” or “whiskey” for products that meet the definition of “whisky”.
The new Rule does not require that fermentation and distillation occur at the same distillery, leaving open the option to have the mash fermenter at a different location such as a brewery. Likewise, aging and bottling can occur at a different location than where the distillation occurred.
See, e.g. Double Eagle Malt (Montgomery County, PA) and Deer Creek Malt (Chester County, PA).

FDA Issues New Guidance on Cosmetic Product Registration and Listing

On December 11, 2024, the U.S. Food & Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products. The guidance provides recommendations and instructions to help individuals and companies comply with the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).
MoCRA mandates that cosmetic companies report serious adverse events to FDA within 15 business days, register their facilities and list their products, ensure product safety before marketing, and comply with FDA’s authority to access records and order recalls if products are found to be unsafe or misbranded.
The updated guidance outlines the statutory requirements for submitting cosmetic product facility registrations and product listings. It finalizes the frequently asked questions (FAQs) in Appendix B (Q1-19) and introduces three new FAQs (Q20-22) for public comment.
- Q20 outlines the responsibilities of a U.S agent, which includes assisting FDA with communications, responding to product inquiries, helping schedule inspections, and receiving documents on behalf of the foreign establishment;
- Q21 explains that multiple buildings within three miles can share one FEI number if they are part of the same establishment and management, and can be inspected together; and
- Q22 indicates that a product listing is generally required for all cosmetic products, including free samples or gifts, unless specific exemptions apply.
The comment period is open until January 13, 2024, and comments can be submitted through the docket.

FDA Affirms Its Decision to Remove 25 Plasticizers From the Food Additive Regulations

In a continuation of the US Food and Drug Administration‘s efforts to conduct post-market reviews evaluating the continued use and safety of chemicals authorized in its regulations, the agency is removing decades-old clearances for food-contact materials based on evolving toxicology concerns. Specialty chemical companies should take note of the development as an example of the way FDA may respond when safety concerns evolve for cleared substances.

Specifically, on October 2024, the Food and Drug Administration (FDA) responded to an objection to its 22 May 2022 final rule amending the food additive regulations (the Final Rule) and affirmed its decision to remove 25 ortho-phthalate plasticizers from 21 C.F.R. Parts 175, 176, 177, and 178. The FDA issued the Final Rule on 20 May 2022 in response to a food additive petition submitted by the Flexible Vinyl Alliance. Several non governmental organizations filed an objection to the FDA’s Final Rule, and in the FDA’s response, the FDA stated that the objection did not provide a basis for modifying the FDA’s Final Rule. While the FDA affirmed its decision, the FDA noted that it is working on an updated safety assessment that will include the remaining authorized uses for phthalates that were not removed from the food additive regulations. The FDA will consider, in part, information it received through its “Ortho-phthalates for Food Contact Use” Request for Information in its evaluation. The FDA’s response explained why the FDA’s action with respect to the Final Rule was reasonable.

The FDA also received objections to the agency’s denial of a separate food additive petition (food additive petition 6B4815) in which the National Resource Defense Council (NRDC) requested that the FDA revoke authorized food contact uses of 28 phthalates due to alleged safety concerns. The FDA concluded that the NRDC did not establish a basis for modifying or revoking the denial order as requested in their objections. According to the FDA, the NRDC failed to establish sufficient support to take the requested action of grouping the 28 phthalates as a class and revoking their authorizations for the 28 phthalates on the basis that they were unsafe as a class. The FDA took issue with reviewing all 28 phthalates together as a class by applying data from one chemical to the entire group as the NRDC suggested. The FDA found that available information did not support grouping the phthalate chemicals into a single-class assessment and noted that 23 of the 28 phthalates were no longer in use and had been revoked in the Final Rule issued at the same time as the denial of the safety-based petition.

The FDA’s forthcoming post-market assessment(s) of the ortho-phthalates whose uses remain the subject of applicable food additive clearances may be an example of the procedures that the FDA will utilize for its post-market assessment of chemicals in food that is currently under development. The proposed post-market assessment process was the subject of a recent public meeting, attended by our Senior Scientific Advisor, Dr. Peter Coneski, at the FDA’s White Oak Campus on 25 September 2024. The public comment period for the FDA’s proposal for an enhanced systematic process for the post-market assessment of chemicals in food remains open until 6 December 2024. We are monitoring these and other developments affecting the regulation of food contact materials in the United States and other jurisdictions.

9th Circuit Finds ‘Fruit Naturals’ Label Not Deceptive

The 9th Circuit Court of Appeals affirmed the dismissal of a class action alleging that Del Monte Foods, Inc., falsely advertised its “Fruit Naturals” fruit cups as “natural” despite containing synthetic preservatives. The original lawsuit was filed in early 2023 and dismissed in October of that year.
The fruit cups, which are labeled as “Fruit Naturals,” contain ingredients like potassium sorbate and methylcellulose gum. According to the plaintiff, Del Monte did not disclose that these ingredients are synthetic, and consumers are not “expected or required to ‘scour’ a product’s listed ingredients” to determine whether products are, in fact, natural. However, the district court found that, because the ingredients are specifically listed on the back label, the label was not “unambiguously deceptive” because the “front label, as clarified by the back label, [would not] mislead a reasonable consumer into thinking that the products don’t contain synthetic ingredients.”
In affirming the district court ruling, a 9th Circuit panel found that a survey cited by the plaintiff to support the deceptive nature of the label was uninformative because it asked respondents about the adjective “natural,” rather than the noun “naturals.” Here, the word is used as a noun in the name of the product. Further, the label depicts the picture and name of the fruit in the cups followed by the phrase “in extra light syrup.” This conveys that the fruit itself is natural, but the syrup may not be.
According to the panel, the labels are ambiguous, meaning that “’reasonable consumers would necessarily require more information before they could reasonably conclude’ that the front label makes a specific factual representation.” A reasonable consumer would look to the back label, which, here, “accurately and clearly discloses several synthetic ingredients,” thus resolving the ambiguity.

FDA Partners With Purdue University to Study Salmonella Risks

FDA has partnered with Purdue University and Indiana produce industry stakeholders to launch an environmental microbiology study to better understand the ecology of human pathogens, focusing on assessing risks related to Salmonella in the environment. The study is intended to develop a better understanding of the source of pathogens, their persistence, and how they transfer through the growing environment to ultimately help inform food safety practices.
The study is in response to outbreaks of Salmonella linked to cantaloupe grown in the Southwest Indiana agricultural region where a specific source or route of contamination was not found. The identification of other Salmonella varieties that were genetically similar to other isolates collected in the region over the last decade suggests that Salmonella is a reoccurring issue and that multiple reservoirs for Salmonella spp. may exist. According to FDA, “[t]he outbreak investigations have shown that there are complex environmental survival, proliferation, and dispersal mechanisms of pathogens in this region that need to be better understood.”
Researchers will sample air, soil, water, and animal scat, as well as collect weather data, to better understand what environmental conditions may encourage the survival, growth, and spread of pathogens. The study will occur at a farm in central Indiana, four Purdue-operated farms in northwest Indiana, and the Southwest Purdue Ag Center.
Indiana ranks sixth in U.S. cantaloupe production, according to USDA data from 2018 when Indiana growers planted 1,800 acres of cantaloupe worth $8.6 million. Growers “want to participate in this study because of their commitment to do everything they can to keep their produce as safe as possible.”

22 States Join Challenge to Massachusetts’ Question 3

Similar to California’s Proposition 12, Massachusetts’ Prevention of Farm Animal Cruelty Act (also known as “Question 3”) imposes animal welfare standards for hens, sows, and veal calves raised in Massachusetts and makes it unlawful for businesses to sell eggs, veal, or pork that they know to be in violation of these standards (even if the animals were raised out of state).
A July 22^nd order from the U.S. District Court of Massachusetts dismissed a challenge to the law brought by various pork producers, holding that the law was not preempted by the Federal Meat Inspection Act (FMIA) because it does not regulate how slaughterhouses operate. This decision has been appealed to the First Circuit Court of Appeals.
Last month the pork producers’ appeal was joined by Iowa (the top pork-producing state) as well as 21 other states. The states’ brief argues that the law will increase costs for pork producers (and prices for consumers) and that such state laws, if upheld, could create a regulatory maze of differing state requirements. We note that such arguments were not foreclosed by the Supreme Court’s 2023 Proposition 12 decision (National Pork Producers Council v. Ross) which held that such laws violate the dormant commerce clause if the “burden imposed on interstate commerce” is “clearly excessive in relation to the putative local benefits.” Nevertheless, it’s not clear how such a fact-based argument can be evaluated on appeal. The states’ brief also latches onto Justice Kavanaugh’s concurring opinion in National Pork Producers Council v. Ross and states that Question 3 “may also implicate other constitutional provisions like the Import-Export Clause and the Full Faith and Credit Clause.”

FDA Releases Summary Report on Fresh Herbs Sampling Assignment

On July 26, 2024, the U.S. Food and Drug Administration (FDA) released findings from its sampling assignment that collected and tested domestic and imported basil, cilantro, and parsley. FDA sought to estimate the prevalence of Cyclospora, Salmonella, and Shiga toxin-producing Escherichia coli (STEC) in these herbs as part of its ongoing effort to ensure food safety and prevent contamination.
From September 2017 to September 2021, FDA collected and tested 1,383 samples of fresh basil, cilantro, and parsley. The Agency detected Salmonella in 17 samples, detected Cyclospora in 18 samples, and detected STEC in 1 sample. The contaminated products were quickly removed from the market.
The sampling assignment was conducted in response to food-borne illness outbreaks of Cyclospora, Salmonella, and STEC. From 2000 through 2016, cilantro was potentially linked to at least three outbreaks in the US. And since 2017, the US has experienced at least six additional outbreaks involving basil, cilantro, and parsley. More than 1,200 illnesses and 80 hospitalizations were tied to these outbreaks.

Kroger Faces Civil Lawsuit Over Calorie Claims on Bread Products

The District Attorney’s Offices of Ventura and Santa Barbara Counties have filed a civil lawsuit against The Kroger Co. in Santa Barbara Superior Court alleging that Kroger had violated California’s false advertising and unfair competition laws. Kroger operates several grocery stores across California such as Ralph’s, Food 4 Less, and Foods Co.
The complaint alleges that, between November 2018 and June 2022, Kroger marketed its CARBmaster Wheat and CARBmaster White breads as containing 30 calories per slice, while the actual calorie content was alleged to contain 50 calories or more. Additionally, the complaint alleges that false CARBmaster calorie counts were displayed on both the front packaging and the Nutrition Facts Panel before June 2022. The complaint further alleged that Kroger persists in misleadingly advertising inaccurate, lower calorie counts on its websites to this day.
Ventura County District Attorney, Erik Nasarenko, emphasized the importance of accurate nutritional information for consumer health and the unfair advantage false advertising provides over compliant competitors. “Consumers rely on nutritional information to make important decisions about their personal health and well-being,” he said. “For some consumers, these decisions are based upon medical necessity. False advertising of calories can mislead, or even endanger consumers, and it provides an unfair advantage over competitors who are advertising in compliance with FDA guidelines.”
Santa Barbara District Attorney, John Savrnoch, stressed the importance of consumers’ right to accurate product information, particularly caloric content. “Consumers are entitled to accurate information on products, especially caloric information on food items,” he stated. “My office is committed to protecting the public by enforcing the False Advertising Law and Unfair Competition Law, and we are grateful to jointly prosecute this case with the Ventura County District Attorney’s Office.”

A New Day for “Natural” Claims?

On May 2, the Second Circuit upheld summary judgment in favor of KIND in a nine year old lawsuit challenging “All Natural” claims. In Re KIND LLC, No. 22-2684-cv (2d Cir. May 2, 2024). Although only time will tell, this Circuit decision, in favor of the defense, may finally change plaintiffs’ appetite for “natural” cases.

Over the many years of litigation, the lawsuit consolidated several class action filings from New York, Florida, and California into a single, multi-district litigation with several, different lead plaintiffs. All plaintiffs alleged that “All Natural” claims for 39 KIND granola bars and other snacks were deceptive. Id. at 3. Plaintiff had alleged that the following ingredients rendered the KIND bars not natural: soy lecithin, soy protein isolate, citrus pectin, glucose syrup/”non-GMO” glucose, vegetable glycerine, palm kernel oil, canola oil, ascorbic acid, vitamin A acetate, d-alpha tocopheryl acetate/vitamin E, and annatto.

The Second Circuit found that, in such cases, the relevant state laws followed a “reasonable consumer standard” of deception. Id. at 10. Further, according to the Second Circuit, the “Ninth Circuit has helpfully explained” that the reasonable consumer standard requires “‘more than a mere possibility that the label might conceivably be misunderstood by some few consumers viewing it in an unreasonable manner.’” Id. (quoting McGinity v. Procter & Gamble Co., 69 F.4^th 1093, 1097 (9th Cir. 2023)). Rather, there must be “‘a probability that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.’” Id. To defeat summary judgement, the plaintiffs would need to present admissible evidence showing how “All Natural” tends to mislead under this standard.

The Second Circuit agreed with the lower court that plaintiffs’ deposition testimony failed to provide such evidence where it failed to “establish an objective definition” representing reasonable consumer understanding of “All Natural.” Id. at 28. While one plaintiff believed the claim meant “not synthetic,” another thought it meant “made from whole grains, nuts, and fruit,” while yet another believed it meant “literally plucked from the ground.” Id. The court observed that plaintiffs “fail[ed] to explain how a trier of fact could apply these shifting definitions.” Id. The court next rejected as useful evidence a dictionary definition of “natural,” which stated, “existing or caused by nature; not made or caused by humankind.” Id. at 29. The court reasoned that the dictionary definition was “not useful when applied to a mass-produced snack bar wrapped in plastic” – something “clearly made by humans.” Id.

The court, finally, upheld the lower court’s decision to exclude two other pieces of evidence the plaintiffs offered. First, the Second Circuit agreed that a consumer survey was subject to exclusion where leading questions biased the results. Id. at 21-22. The Second Circuit also agreed that an expert report by a chemist lacked relevance where it assessed “typical” sourcing of ingredients, not necessarily how KIND’s ingredients were manufactured or sourced. Id. at 22-24.

For more news on Food Advertising Litigation, visit the NLR Biotech, Food, Drug section.

Food for Thought: Serving Up Unique Concerns for Restaurant Leases

Many aspects of commercial leasing are complex, but restaurant leases are a unique species of lease. Counsel to restaurants must be cognizant of operational and logistical issues posed by these hospitality businesses, and be prepared to address these key issues to protect the restaurant. Here are some of the most distinctive issues to be aware of when representing a restaurant tenant:

CONSTRUCTION ISSUES

Restaurant construction is different from other tenants’ fit-out work. It involves several moving parts, all of which come together to facilitate the restaurant’s successful operation. These include utilities, heating, ventilation, and air conditioning, managing odors, grease traps, hot water, and fire suppression systems. While counsel need not have the knowledge of a contractor or architect, one must understand the importance of the size of HVAC systems, design of fire suppression and sprinkler systems, the capacity and location of electrical conduit and electrical service, and sanitary and sewer lines and gas lines. For example, grease traps are imperative for restaurants, and it is important to determine (i) whether a grease trap is separate and external, or shared with other tenants, (ii) if shared, how maintenance responsibility and cost will be allocated among the shared users; and (iii) whether the grease trap’s location is convenient for operations.

Mitigation of cooking odors is another key issue, especially in a mixed-use development, shopping center, or an urban residential neighborhood. Some landlords and municipalities require expensive odor control systems, and negotiation is important in determining the size and scope of such measures, especially given the subjective perception of odors generally. It may also be helpful to include an objective standard of negative pressure for odor control. Noise mitigation is likewise an issue as to which landlords may be sensitive. Restaurants draw crowds of people who are out to enjoy themselves, which leads to loud voices, music, and other noise that emanates from the restaurant in a way that may affect other abutters and neighbors, especially residences or hotels.

OPERATIONAL ISSUES

Hours of Operation: All businesses are sensitive to their hours or operation, but it is particularly important for restaurants to understand the impacts that may come with later hours, which often cause landlords concern (especially if the restaurant serves alcohol). If the restaurant has outdoor seating or a patio area, are those hours the same as for the interior space? Some liquor licenses or municipal regulations may also restrict operations, so it is important to understand and comply with the requirements and rules of governing bodies.
Deliveries: Restaurants receive multiple deliveries daily, often greater than other types of businesses. The logistics of delivering food to the restaurant are critically important. Sometimes landlords desire to limit the hours during which deliveries may be made or the loading docks (if any) that may be used. Counsel should know how deliveries will be made and determine whether any restrictions on same will be troublesome to the restaurant’s operations.
Trash: Restaurants generate a substantial amount of trash, both wet and dry, food and nonfood. The location and adequacy of trash storage as well as the frequency of removal are key issues to specify in the lease. Some landlords also require a cold storage area for food waste; and of course care should be taken to avoid vermin infestations. Where will the tenant need to take its trash? If the common trash room is far from the kitchen, that may pose problems for restaurant staff.
Parking: Vehicle parking is an issue for all tenants, but it is often magnified for restaurants. Counsel should understand where the restaurant’s patrons are expected to park, and if desired seek to negotiate designated takeout parking spaces for the restaurant. If there is to be valet parking, or if a development designates certain areas as approved for ride share drop-off and pick-up and not others, counsel should understand whether those services and areas pose a business risk for the client.

EXCLUSIVE ISSUES

Many types of retail businesses seek exclusives in leases, but restaurants are particularly invested in ensuring that landlords do not lease other space to a competitor restaurant. If the development contains a hotel, the restaurant lease should contain an exclusive which prevents the hotel from operating a similar restaurant.

TIMING ISSUES

If the restaurant is located in a mixed-use project or shopping center, or otherwise not on its own parcel, the restaurant will want to negotiate the ability to determine when construction occurs and when it is obligated to open for business. Timing of construction can be a big risk, as delays and interruptions are expensive and set back the opening. Aside from construction timing, opening requirements may be important, especially in light of whether other tenants in the project are open and operating. Restaurant counsel may seek an opening co-tenancy requirement such that the restaurant will not be obligated to open until the major tenant or a substantial portion of the development is also open.

In summary, restaurant leases are more complicated than other retail leasing; and restaurant counsel should be aware of these unique business issues and strive to fully understand the details of its client’s business in order to set the restaurant on a successful path.

For more information on Restaurant Leasing Issues, visit the NLR Real Estate section.

Category: Food & Hospitality