As we’ve written about several times, the 2018 Farm Bill legalized hemp but specified that it must be done pursuant to a state or tribal plan, known as a 279B plan. Such a plan is not effective until approved by the Secretary of Agriculture. The USDA has not yet issued its own hemp plan, and has stated that it will not approve any state or Indian tribe’s plan until after it issues its own. This conundrum places states and Indian tribes who currently wish to allow the production of hemp (but who have not established a plan per the 2014 Farm Bill) in a precarious position.

The tension between participating in the rapidly-growing hemp marketplace and the slow pace of the administrative rulemaking process was brought to the fore in a recent case filed by the Flandreau Santee Sioux Tribe (the “Tribe”) in United States District Court in South Dakota, Flandreau Santee Sioux Tribe v. United States Dep’t of Agric., Case No. 19-cv-04094. In that case, the Tribe argued that the USDA was preventing the lawful production of hemp on the Tribe’s lands. The Tribe had submitted a plan for approval to the USDA on February 29, 2019. In response, on March 19 USDA Secretary Purdue wrote that he would neither approve or deny the plan until after the USDA issued its own hemp regulations – which could be a matter of months, or even years. The Tribe sued, arguing that the USDA should be enjoined from preventing it from lawfully producing hemp. The Tribe requested that the Court issue a preliminary injunction, forcing Secretary Purdue to accept or deny the Tribe’s hemp plan.

On June 6, 2019, the Federal District Court denied the Tribe’s request. In doing so, the Court concluded that the Farm Bill…

“provides exclusive authority to the Secretary to issue rules and regulations that relate to the implementation of 7 U.S.C. § 1639p, the same section under which the Tribe seeks to produce hemp. A harmonious reading of the statute lends to the likelihood that the 60 day window to approve or deny a plan does not begin until regulations are promulgated by the USDA.”

While the Court also found that the Tribe would suffer irreparable harm if it were not allowed to produce hemp under its own plan, the Court concluded that this result was outweighed by the fact that – in the Court’s opinion – the Tribe would not likely succeed on the merits.

Why does this matter? The USDA’s decision not to approve or deny the Tribe’s plan and the Court’s denial of the request for preliminary injunction underscores the uncertainty prevalent relative to the practical application of the 2018 Farm Bill. It also amplifies questions about the degree to which other states or tribes seeking to harmonize their laws with federal policy may face obstacles that limit their participation in this rapidly-expanding marketplace, at least in the short term.

On May 28, 2019, the United States Department of Agriculture’s (“USDA”) Office of the General Counsel issued a Legal Opinion, which attempts to address open questions relating to interstate transport of hemp. While the 2018 Farm Bill legalized hemp production, the current state of the law as to whether it is legal to transport hemp through states that do not currently allow the production or sale of hemp is unclear. We recently published an article describing this very issue and analyzing the conflicting case law stemming from the 2018 Farm Bill.

The USDA’s Legal Opinion made the following three pertinent conclusions:

1. As of the enactment of the 2018 Farm Bill, hemp is no longer a schedule 1 drug under schedule I of the Controlled Substances Act. Hemp and is therefore no longer a controlled substance.

2. After USDA publishes regulations implementing the new hemp production provisions of the 2018 Farm Bill, states and Indian tribes may no longer prohibit the interstate transport of hemp lawfully produced under a state or tribal plan or under a license issued under the USDA’s plans.

3. Currently, states and Indian tribes may not prohibit the interstate transport or shipment of hemp lawfully produced under the 2014 Farm Bill.

USDA’s opinion that de-scheduling is self-executing is notable and the agency goes to some length to ensure its position is clear and explain its rationale. The Legal Opinion states, in part:

“It is important to note that this decontrolling of hemp (and THC in hemp) is self-executing. Although the CSA implementing regulations must be updated to reflect the 2018 Farm Bill amendments to the CSA, neither the publication of those updated regulations nor any other action is necessary to execute this removal.”

USDA then goes through the primary objections to this position and explains why they are invalid. The first objection is that rulemaking is required to modify the CSA. To that, USDA responds that rulemaking is not required. Congress has authority to amend the CSA and has done so several times. The second objection is that because the change is not yet reflected in the regulations, 21 C.F.R. § 1308.11, the change is not effective. USDA argues that where Congress amends the schedules to add or remove a controlled substance, that change is effective immediately upon enactment.

Regarding transport specifically, as discussed in our article, there is conflicting case law regarding whether hemp produced pursuant to the 2014 Farm Bill provides an adequate safe harbor allowing the interstate transport of that hemp, notwithstanding any state law prohibiting hemp’s transport or sale. It has been addressed by district courts in California and West Virginia, both of which held that the transport in question was allowed. The issue is before the Ninth Circuit currently and is likely to be decided this Fall.

In the meantime, the USDA’s Legal Opinion provides some much needed clarity as to the agency’s position, allowing the interstate transport of hemp produced pursuant to the 2014 Farm Bill. The Legal Opinion confirms the USDA’s position that while states and Indian tribes will still be able to regulate the production of hemp in their jurisdictions, they are preempted from regulating the interstate transport of hemp produced in accordance with either the 2014 Farm Bill or the 2018 Farm Bill. While courts will not necessarily follow the USDA’s Legal Opinion – and are not beholden to it – it is certainly important dicta that courts should and likely will pay attention to when dealing with the issue of the interstate transport of hemp in the coming months.

With CBD projected to be a $450 Million industry in the coming year, FDA hosted a packed house of industry stakeholders last week in a day-long public meeting that was the kickoff of a discussion to determine whether there is a pathway for CBD in ingestible products such as foods and dietary supplements.  See our summary of key themes here and check out this podcast episode to hear five key takeaways. 

Earlier this week, the House Appropriations Committee approved the fiscal year 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill by a vote of 29 to 21. The committee report accompanying the bill included notable language on CBD.  Specifically, it expressed concern regarding potential safety issues such as drug interactions, somnolence, liver toxicity, the presence of THC or other compounds, and aggressive health benefit claims.  These were among the many issues discussed at FDA’s May 31 public meeting.

The report urges the agency to focus on public health and, should there be a non-drug pathway for CBD, to preserve the incentives to invest in drug-level research. It states in part:

The Committee recognizes the FDA is considering a public regulatory process to evaluate the appropriateness, and possible parameters, of a regulatory pathway that would permit CBD in certain foods and dietary supplements. The Committee expects the FDA to assert its commitment to identifying lawful federal regulatory pathways for CBD foods and dietary supplements if such pathways are consistent with protection of the public health. Such pathways may include necessary public health and safety parameters that will protect the public health, such as labeling requirements and limits on CBD or other cannabis-derived ingredients in products, based upon anticipated total exposure levels. The Committee also expects the FDA to preserve the integrity of its drug development and approval processes, which ensures that products marketed for drug uses have undergone a rigorous scientific validation process demonstrating quality, safety and efficacy. It is also imperative that any FDA regulation of foods and dietary supplements containing CBD or other cannabis-derived ingredients preserve incentives to invest in robust clinical study of cannabis, so its therapeutic value can be more fully understood.

This position from the House Appropriations Committee stands in contrast to other Congressional pressure on FDA regarding CBD. Specifically in a January 2019 letter, Sens. Wyden and Merkley, both Democrats from Oregon, urged then-Commissioner Scott Gottlieb to “immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and give U.S. producers more flexibility in the production, consumption, and sale of hemp products.”  The letter demanded that FDA answer questions regarding whether food and dietary supplement pathways were available for hemp products, even though FDA had recently announced three GRAS affirmations on hemp ingredients and re-stated its public position regarding CBD.

What’s the takeaway? The House Appropriations Committee, charged with review of funding for FDA, wants public health and rigorous clinical evaluation to be the top priorities.  Meanwhile, as evidenced by Sens. Wyden and Merkley (among many others), consumers are clamoring for CBD and U.S. businesses are fearful of losing opportunity.  Given that FDA has acknowledged that the administrative notice and comment process may not be the most efficient way to address CBD pathways, we shall see whether the agency can strike a balance between the call for regulation that protects and informs consumers and the business community’s fear of missing out.

FDA’s CBD Public Meeting featured a full house of manufacturers, researchers, health professionals, trade association representatives, and other stakeholders.  Each speaker was given a few minutes to offer their input in response to FDA’s call for submissions relating to health and safety risks; manufacturing and product quality; and  marketing, labeling, and sales.  Here are key themes and highlights:

  • Opening Remarks:  Acting FDA Commissioner Ned Sharpless opened the meeting by acknowledging the “explosion” of consumer interest and the complexity of the task that FDA faces given hemp’s long prohibition:  “When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety,” he noted.  He also responded to Congressional and stakeholder pressure to explore a pathway for CBD in foods and dietary supplements by noting that the agency has a high-level working group focused on the issue.
  • Regulatory Structure:  Per the Natural Products Association, approximately 1500 new CBD products have been introduced over the last three years.  Overwhelmingly, manufacturers and trade association representatives called on FDA to provide a predictable pathway to market, in large part by enforcing existing laws relating to product categories, such as DSHEA.  Multiple speakers discussed the history of hemp in the diet as the basis for treatment of hemp extracts as a safe dietary ingredient, with some acknowledging that CBD isolate could be continued to be regulated as a drug.  In addition, there were many calls to enforce quality standards such as GMPs, identity testing, product testing for contaminants, labeling requirements, and adverse event reporting.

The three to five year timeframe that FDA previously referenced for a potential new regulation was a significant concern to many stakeholders.  Several speakers called on FDA to issue guidance as it explores a potential pathway for CBD in foods.  One speaker, Douglas MacKay of CV Sciences, encouraged FDA to create a “lane” for different product categories, i.e., drugs, foods, dietary supplements, based on dosages and intended use, using omega-3s as an example of an ingredient that currently exists in similar “lanes.”

  • Consumer Use and Understanding:  Lisa Gill from Consumer Reports presented consumer survey data with several interesting findings, including the following:  26% of U.S. consumers have used CBD.  Of these, edibles are the most commonly used.

Consumers are most likely to obtain CBD from a cannabis dispensary.

And – perhaps most interesting from a public health perspective – many consumers replace OTC or Rx medications with CBD and are strongly of the opinion that it is effective.

  • Marketing and Labeling:  Many speakers expressed concern over aggressive product claims, questionable manufacturing and testing practices, and adulteration with not just THC but other contaminants.  Several speakers presented data based on product sampling and testing of CBD content, THC content, contaminants such as lead, pesticides, etc.  Generally speaking, the takeaway was that CBD products feature highly variable potency and contamination levels.  Two speakers who had conducted separate product surveys each found just one product that featured 100% of the amount of CBD listed on the label.  Others contained no CBD and some contained multiples of the label claim.  In addition, in one survey, 45% of products tested contained THC, although amounts detected were not indicated in the results presented.

  • Health and Safety Risks:  The World Health Organization report regarding CBD was cited by several speakers as support for the general safety and lack of evidence of addictive properties.  However, key concerns noted included limited understanding of potential drug interactions between CBD and other medications and, in particular, the dose/effect relationship between such interactions.  GW Pharmaceuticals and academic researchers acknowledged the potential for CBD-associated liver damage discovered during the Epidiolex trials and other studies.  Other speakers encouraged FDA to review data gathered from state medical marijuana programs (some of which include CBD products) relating to adverse events and drug interactions.  The effect of cumulative exposure from several product types was also cited as an area requiring further research.
  • Research Restrictions:  Researchers from several universities throughout the countries as well as practitioners of several specialties presented findings based on clinical studies and patient treatment with CBD and medical marijuana.  While their interests varied, they universally supported more research into the safety and efficacy of CBD and expressed concern about their ability to access market-grade product for research.  In particular, they cited restrictions relating to DEA scheduling, DEA’s delay in issuing cannabis permits, the inferior quality of cannabis (marijuana) that is obtainable from the U of Mississippi (the only federally-sanctioned site for cultivation), the IRB process, and related gating steps that are required for clinical studies as barriers to pursuing research.

*                            *                            *

Throughout the day, FDA panelists asked a variety of questions such as what the speakers believed are the health benefits of CBD, what support they have for that conclusion, the number of new manufacturers who have entered the CBD market over the last few years and the degree to which they are following GMPs, and the body of evidence relating to food producing animals and pet products generally.

As expected, the meeting was largely a listening exercise and the first step in a deliberative process.  Comments can be filed until July 2.

Assembly Bill 228 is a promising piece of legislation that could soon bring an end to California’s prohibition on adding hemp-derived CBD to foods, beverages, and cosmetics.  The bill, in its current form, would add two provisions to the California Health and Safety Code clarifying that food, beverages, and cosmetics are “not adulterated by the inclusion of industrial hemp, as defined in Section 11018.5, or cannabinoids, extracts, or derivatives from industrial hemp.”  The provisions would further provide that such items “that include industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp shall not be restricted or prohibited based solely on the inclusion of industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp.”

AB 228 stands in direct contrast to the California Department of Public Health’s (“CDPH”) current policies.  As we wrote about here, in July 2018, CDPH released a set of FAQs that included a summary of the agency’s position on CBD being added to foods:

Until [1] the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or [2] California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.

Neither of these thresholds have been met: The FDA’s position is still that hemp-derived CBD cannot be used as a food, and AB 228, as amended, does not explicitly state that hemp-derived CBD products are safe to use for human and animal consumption.  Further, the CA bill does not list dosage thresholds for use in any product.

Despite this official position, CDPH’s FAQ is not law, and it has not been systematically enforced.  While hemp CBD products are widely available in California, passage of AB 228 seems likely to expand that state’s market even further by clarifying and sanctioning a pathway to market.  While FDA retains jurisdiction over foods transported in interstate commerce, the size of California’s economy and the number of states that currently allow CBD in foods is pushing toward critical mass and geographic distribution, potentially making FDA’s role in regulating this issue even more complex.

The Alcohol and Tobacco Tax and Trade Bureau (“TTB”) recently updated its guidance on inclusion of hemp ingredients in beverages containing alcohol. Here’s a summary:

• It remains TTB’s policy that it will not approve any formulas for alcohol beverages that contain ingredients that are controlled substances under the federal Controlled Substances Act.
• TTB is continuing to consult with the FDA on the use of ingredients derived from hemp.
• After consultation with FDA, TTB is returning for correction any applications for formulas containing “hemp” ingredients – other than ingredients derived from hemp seeds or hemp seed oil.

In short, TTB is following FDA’s position that it is unlawful to introduce or deliver for introduction into interstate commerce a food to which CBD or THC has been added. This topic is slated for a full day of discussion at the public hearing that FDA is holding on May 31.

For those readers who may be new to regulation of alcohol and how this relates to FDA, here’s the high-level:

• The Federal Alcohol Administration Act (“FAAA”) governs interstate commerce of wine, spirits, and malt beverages as defined in the statute. TTB is the agency charged with administering the FAAA.
• Unlike FDA, TTB requires that labels and formulas for products within its jurisdiction must be submitted prior to sale.
• Not all alcohol beverages fall within the FAAA, however, leaving FDA with jurisdiction over products that fall outside of the stated definitions.
• Transport in interstate commerce is required for either agency to have jurisdiction.

This isn’t the end of the story, though. As with all things related to CBD, state laws regarding inclusion of CBD in food products and alcohol are a patchwork, including some at the local level as we’ve written about here. Companies entering this space will want to sort through these complexities and follow the dynamic legal environment closely.

The FDA and FTC jointly issued warning letters to three companies selling CBD products online. The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”). Although this is the first time the FDA and FTC have issued joint warning letters relating to CBD, the FDA has been involved in CBD enforcement for the past few years.

Since the passing of the 2018 Farm Bill, which descheduled hemp and hemp derivatives under the federal Controlled Substances Act, the FDA has become the primary federal regulator relative to foods, drugs, cosmetics, and dietary supplements that contain CBD from hemp. The FDA’s most visible enforcement on CBD products to date has been in the form of warning letters issued to online retailers of products labeled as dietary supplements that feature aggressive disease treatment claims. The FDA also tested CBD products in conjunction with warning letters issued in 2015 and 2016 to determine whether they contained the CBD levels listed on the labels.

In the letters from last week, the FDA turned its focus onto various CBD products marketed online as “drugs,” including “CBD Salve,” “CBD Oil,” “CBD for Dogs,” “Hemp Oil,” “CBD Softgels,” “Liquid Gold Gummies (Sweet Mix),” “Liquid Gold Gummies (Sour Mix),” and “blue CBD Crystals Isolate 1500mg.” The FDA determined that the companies’ websites contained claims about their CBD products that established them as unapproved “drugs” under section 201(g)(1) of the FDCA. The letters also referenced the FTC’s substantiation standard, stating the FTC had concerns that certain efficacy claims that were made may not be substantiated by competent and reliable scientific evidence. They also warned that violations of the FTCA may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order, possibly including a requirement to pay back money to consumers.

As noted above, these letters are unique, as it is the first time the FDA has issued a joint FDA/FTC warning letter relating to CBD. This is also the first time the FDA has referenced the FTC’s substantiation standard or threaten any specific penalty for violations of the FTCA. For companies marketing CBD, it is important to keep in mind that although the market has flourished despite a host of regulatory uncertainties, it is the regulators’ opinion that the rules regarding advertising and health claims are clear. Competent and reliable scientific evidence remains the standard.

Over the last few years, however, the FTC’s health claim enforcement has featured several false cure-type products. Cases against Regenerative Medical Group, Cellmark, iV Bars, and Nobetes challenged unproven representations for products promising to treat Parkinson’s disease, macular degeneration, cancer, multiple sclerosis, and diabetes. Although we have yet to see the FTC announce any settlements relating to CBD products, these letters signal that FDA is not alone in its concern over aggressive CBD treatment claims.

The warning letters can be found here:

Advanced Spine and Pain, LLC (d/b/a Relievus)
Nutra Pure LLC
PotNetwork Holdings, Inc.

On March 5, 2019, FDA Commissioner Scott Gottlieb, M.D. and FDA/CFSAN Director, Susan Mayne, Ph.D., released new independent test results confirming asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.  The agency also issued a safety alert warning consumers not to use the cosmetic products sold by Claire’s that had tested positive for asbestos that, at the time, had yet to be recalled.  FDA announced a voluntary recall on March 12th.

The FDA statement issued in conjunction with these actions stressed the importance of cosmetic safety and key challenges presented by the cosmetic provisions of the federal Food, Drug and Cosmetic Act (FDCA). The FDA noted that the provisions, which have not been updated since the law was enacted in 1938, do not require cosmetic manufacturers to test their products for safety. Thus, the agency called on the cosmetic industry to do more to ensure product safety, noting that FDA has “only limited tools” regarding cosmetics and is “dependent on manufacturers” that “bear critical responsibilities” related to product safety.

The FDA statement laid out a number of steps the agency is taking “to reinforce the obligations of manufacturers” to ensure the safety of the cosmetic products they market. As FDA determines further steps it should take to protect consumers, the agency has identified a few action items to better understand the cosmetic industry:

  • Working “with cosmetics manufacturers and requesting information about what procedures they use to ensure their cosmetics are safe” and that “talc used in any cosmetic product is free from asbestos”;
  • Investigating how manufacturers source talc with appropriate traceability, and whether they test raw talc and/or their finished products;
  • Determining how many cosmetics products contain talc; and
  • Evaluating whether manufacturers have received adverse event reports associated with talc-containing products.
  • FDA also expressed a commitment to take other actions based on the agency’s existing authority under the FDCA “by leveraging [such] authorities to the greatest extent.”  This includes:
  • Making determinations if certain cosmetic ingredients should be prohibited or restricted;
  • Testing products made with talc and taking the necessary regulatory and enforcement actions; and
  • Creating an interagency working group to propose draft standards to improve consistency for talc testing.

In addition, the FDA statement calls upon cosmetic firms to take the following voluntary actions, which are not currently required under the FDCA for cosmetic products manufacturers:

  • Register cosmetic products and list ingredients, including talc, that are used in their cosmetic products with the Voluntary Cosmetic Registration Program; and
  • Proactively report adverse events involving cosmetic products to the CFSAN’s Adverse Event Reporting System.

The statement suggests that the current “outdated” FDCA cosmetic framework, and the limited resources available for FDA’s cosmetic programs, are impediments to ensuring cosmetic safety and consumer protection. To remedy this, the agency proposes working with stakeholders and Congress to “modernize” the scope of FDA’s cosmetic authority in light of “the industry’s significant expansion.” Potential legislative action may have elements that resemble the FDA Food Safety Modernization Act (FSMA), enacted in 2011, and other FDCA provisions that currently apply to foods. As FDA explained:

To improve consumer safety and secure our mission for years to come, a more modern approach could include tools that are tailored for cosmetics, including appropriate frameworks for registration and listing of products and their ingredients, good manufacturing practice regulations, company reporting of adverse events, access to records (including consumer complaints) during routine or for-cause inspections, mandatory recalls, disclosure of known cosmetic allergens on a product’s label, and ingredient review.

FDA’s actions have been met with congressional approval as at least one congressman has indicated that legislative action may already be in the works. On March 5, 2019, Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) released a statement commending FDA’s commitment to ensuring the safety of cosmetics noting:

Every day millions of Americans assume the cosmetics they use are safe, but unfortunately that is not always the case. The reality is that cosmetics are one of the least regulated consumer products on the market and FDA acknowledged today that the agency does not have the necessary authority to oversee the industry. . . . Unfortunately, FDA does not currently have the authority to mandate a recall on the products. Examples like Claire’s refusal to voluntarily recall their asbestos-tainted products demonstrates the need to modernize the current regulatory framework for cosmetic and personal care products to ensure that FDA can act to protect consumers when industry fails to do so. That is why I have already begun the process of circulating a bipartisan discussion draft on a proposal to update our laws for the first time in over eighty years.

On March 7, 2019, Senators Feinstein (D-CA) and Collins (R-ME) introduced a co-sponsored bill entitled, the “Personal Care Products Safety Act.” The bill is designed to expand FDA’s authority to regulate personal care products, including by authorizing FDA to: review the safety of at least five cosmetic ingredients annually; recall unsafe products; establish new labeling requirements; establish adverse event reporting requirements; and require companies to register with FDA annually and provide the agency with information concerning their products’ ingredients.  The bill would also direct FDA to issue Good Manufacturing Practices regulations and authorize the agencies to collect user fees from product manufacturers to fund these activities.  A number of companies and health and consumer organizations support the bill.

FDA’s recent announcement indicates it recognizes the growth of the cosmetic industry and is subsequently seeking ways to increase its regulatory oversight. We will continue to keep you posted with any updates in this space.

The National Milk Producers Federation (NMPF) yesterday submitted a citizen petition to FDA related to the use of dairy terms such as “milk,” “yogurt,” “cheese,” “ice cream” and “butter” in the statements of identity for non-dairy plant-based substitutes. The petition argues that the use of these standardized dairy terms to name non-dairy foods falls short of FDA requirements, “falsely implies that the non-dairy substitutes are equivalent to and interchangeable with standardized dairy foods,” and “fails to disclose the material facts concerning how these non-dairy substitutes differ from standardized dairy foods or adequately distinguish non-dairy substitutes derived from different plant sources.”

The NMPF petition asks that the Agency: (1) take enforcement action against misbranded non-dairy foods that substitute for and resemble reference standardized dairy food(s) but are nutritionally inferior to the reference food and include the name of the reference food in the statement of identity; and (2) amend section 101.3(e) of FDA regulations to codify policies that permit use of standardized dairy terms for non-dairy substitutes that resemble and substitute for the same reference dairy food only under defined conditions.  The latter proposal to amend section 101.3(e) would be limited in the following notable ways:

  • The proposal applies only to “non-dairy foods that substitute for and resemble standardized dairy foods,” which are defined as foods that contain no single dairy ingredient or combination of dairy ingredients in amounts that are sufficient to constitute major ingredients and that substitute for and resemble a food that is a standardized dairy food (e.g., “milk,” “yogurt,” “cheese,” “ice cream” and “butter”).
  • The proposal applies distinct requirements depending on whether the non-dairy substitute food is nutritionally inferior or nutritionally equivalent to the reference standardized dairy food:
    • For nutritionally inferior non-dairy substitute foods, the statement of identity could identify a reference standardized dairy food, provided that either: (1) the name of the food were qualified through use of the legally defined term, “imitation”; or (2) the name of the food were qualified through use of the term “substitute” or “alternative” and material differences including nutritional inferiority and performance limitations were disclosed.
    • For nutritionally equivalent non-dairy substitute foods, the statement of identity could identify a reference standardized dairy food, provided that the name of the food were qualified through use of the term “substitute” or “alternative” and material differences, including performance limitations, were disclosed.
  • The proposal would not apply to non-dairy foods that do not: (1) substitute for and resemble a standardized dairy food; and (2) reference the standardized dairy food substituted for and resembled as part of its statement of identity (i.e., would apply to “oat milk, “ but not “oat beverage”).

The Statement of Grounds in the NMPF petition argues that the enforcement and regulatory actions the petition asks FDA to undertake are amply justified on statutory, regulatory and First Amendment grounds, and advance FDA’s consumer protection and public health policy objectives.

The NMPF petition was filed in the wake of the agency’s recent request for public comment on related issues, which resulted in more than 13,000 comments being filed in the FDA docket.