Increasing consumer interest in cannabis-derived ingredients has led to an explosion of the use of the non-intoxicating cannabinoid, cannabidiol (CBD) in a wide variety of products, including drugs, foods, dietary supplements, personal care products, and cosmetics for both human and animal use. While CBD-containing products continue to proliferate – online and in stores across the globe – regulators have struggled to keep pace with the marketplace, and are now starting to examine and exercise their enforcement authorities over CBD-containing products.

Confusing matters further, numerous media outlets have reported that CBD is now “legal.” In the U.S., the recent passage of the 2018 Farm Bill clarified that hemp, and hemp-derived ingredients including CBD, are not Schedule I substances under the Controlled Substances Act. While this change brought much-needed clarity to the legal distinction between Cannabis that is considered non-controlled hemp and Cannabis that is illegal marijuana, hemp-derived CBD remains subject to regulation by several regulatory agencies at both the federal and state level.

FDA has taken the view CBD cannot be marketed as an ingredient in foods or dietary supplements under the exclusionary clauses of the statute that prohibit a substance from marketing as a food or dietary supplement if it was first studied as an investigational new drug. States such as Maine recently started enforcing the FDA position by taking market action against CBD-containing food and dietary supplements.

The uncertainty and complexity around the use of CBD in foods, dietary supplements, and cosmetics is not unique to the U.S. In the U.K., where a booming marketplace for CBD-containing products has also emerged, the Food Standards Authority (FSA) recently determined that CBD is a novel food ingredient and is advocating for removal of CBD-containing foods from the marketplace until CBD is approved as a novel food.

The ever-changing landscape for CBD underscores the need for companies to closely monitor regulatory developments and conduct appropriate diligence before commercialization of a product in their market.


In this year’s edition of Consumer Horizons, the Hogan Lovells global Consumer team identifies trends that will impact food and beverages companies, fashion and luxury goods producers, retailers, consumer electronics manufacturers, and other consumer companies throughout 2019.

Download Consumer Horizons 2019 by registering here.

The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the Draft Guidance). 1/ As FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier explained, part of FDA’s work is “keenly focused on guiding companies on steps needed to ready their facilities and staff for possible recall situations.” The Draft Guidance is the latest step in the Agency’s efforts over the past 18 months to proactively and systematically update the FDA recall process.

Plaiser points to several examples of recalls that took place in the past 12 months that demonstrate that the improvements FDA and industry have implemented can result in more timely information being available to consumers. Plaisier also states that the agency’s work to improve recall timeliness will continue and that FDA encourages the use of new technologies that can identify and communicate recall events more quickly and efficiently.

The Draft Guidance has four sections: A) preparing to facilitate timely initiation of a voluntary recall, B) identifying and responding to potential problems with distributed product, C) initiating a voluntary recall, and D) FDA’s role in initiating a voluntary recall in a timely manner. In terms of significance, Plaisier highlights three key recommendations – training, record keeping, and procedures.

This post is a summary of the FDA draft guidance document. Click here to read more. 

Many food and beverage companies are assessing the use of hemp-derived ingredients in their products in light of the 2018 Farm Bill provisions excluding “hemp” from the definition of marijuana under the federal Controlled Substances Act. At the same time, regulators at both the federal and state level continue to explore and develop regulatory frameworks to govern the use of hempderivatives in food. The Alcohol and Tobacco Tax and Trade Bureau (TTB) is the latest federal agency to issue guidance on the use of hemp-derived ingredients. This guidance illustrates that TTB is actively thinking about industry desire to use hemp-derived ingredients, such as cannabidiol (CBD), in alcohol beverage products and that TTB is communicating with FDA to establish clearer guidance for industry.

Click here to read more. 

U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era of smarter food safety (the Statement). The Statement reflects on the evolution of our food system from an “around the corner” network to one that is “around the world.” It posits the next 10 years will see more innovation in the food sphere than the past 20. As such, the agency is looking to augment its food safety work such as implementing FDA Food Safety Modernization Act (FSMA) requirements and its use of technologies such as whole genome sequencing and the GenomeTrackr Network, by leveraging, among other things, the use of new and emerging technologies to create “a more digital, traceable, and safer system.” The Statement announces two new FDA initiatives – one an artificial intelligence pilot program for imported foods review, the other a “Blueprint for the New Era of Smarter Food Safety.” The agency will seek stakeholder input through a public meeting later this year on the Blueprint, addressing the key areas traceability, digital technologies, and evolving business models. In brief, the agency views the new era of smarter food safety as one that is “people-led, FSMA-based, and technology-enabled.”

Click here to read more. 

Last week, the Centers for Disease Control and Prevention (CDC) released a report entitled, “Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food – Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2015-2018” (the Report). The Report summarizes data collected by the Foodborne Diseases Active Surveillance Network (FoodNet), which tracks infections caused by eight pathogens in ten sites covering approximately 15% of the U.S. population. The Report summarizes preliminary 2018 data and changes since 2015. The Report reflects an overall upward trend in foodborne illness incidence rates, although CDC notes that trend may at least partly reflect increased testing. The Report is part of an ongoing effort by CDC to review and update its foodborne illness findings periodically.

The Report is focused on illness trends by pathogen rather than product commodity. However, CDC identifies produce, raw chicken, raw meat, and eggs, as potentially significant drivers of foodborne illness, and the Report calls for greater control measures for these products.

In total, FoodNet identified 25,606 infections, 5,893 hospitalizations, and 120 deaths in 2018. The attached Table 1 and Figure 1 reflect key data from the Report.

Click here to read more. 

Driven by the continuous demand of more eco-friendly packaging materials for food and beverage products, there is a growing interest in the use of recycled packaging as part of a company’s sustainable initiative. Businesses, however, are well advised to pay close attention to the regulatory issues on the horizon that are presented by the use of recycled materials in food and beverage packaging.

On the federal level, the U.S. Food and Drug Administration (FDA) exercises jurisdiction over food packaging materials. FDA considers each proposed use of recycled plastic on a case-by-case basis and issues informal advice (“no objection letters”) as to whether the recycling process is expected to produce plastic or paper suitable for food-contact applications. While the FDA review process can be time and resource consuming, it is the state laws that pose the most challenges for the sustainable packaging industry.

In particular, under the Model Toxics in Packaging Legislation, a national environmental initiative to reduce the heavy metals in solid waste through state legislations, the combined levels of lead, cadmium, mercury, and hexavalent chromium in packaging materials are required not to exceed 100 ppm. A total of 19 states have adopted the model legislation. The levels can present potential challenges to recycled glass because it typically contains higher levels of heavy metals than virgin glass. To date the model regulations have overlooked because the glass matrix encapsulates the heavy metals, making them incapable of migrating into the beverage. Why does recycled glass contain higher levels of heavy metals? It likely is a result of consumers putting crystal, light bulbs, and industrial glass into the recycling stream.

Another state law of note is California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65). Under Proposition 65, businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone in California to a listed chemical. Violations of Proposition 65 are subject to civil penalties. Proposition 65 warning requirement for two chemicals commonly found in food service wares – PFOA and PFOS becomes effective in November 2018. Companies selling PFOA/PFOS-containing food packaging materials in California are vulnerable to private litigants or “bounty hunters” who can bring private lawsuits to enforce the Prop 65 warning requirements.

In addition to the state laws, we also expect consumer interest groups such as the Center for Science in the Public Interest (CSPI) to continue their campaign against the use of certain chemicals in packaging. Chemicals including heavy metals, PFOA/PFOS, BPA, and PAHs in the packaging materials will continue to be portrayed as poster child for “bad chemicals.”


In this year’s edition of Consumer Horizons, the Hogan Lovells global Consumer team identifies trends that will impact food and beverages companies, fashion and luxury goods producers, retailers, consumer electronics manufacturers, and other consumer companies throughout 2019.

Download Consumer Horizons 2019 by registering here.

Last week, the FDA released a draft guidance regarding the low calorie sweetener, allulose, and stated the agency will not treat this ingredient as contributing to total or added sugars content in the nutrition information.

In particular, FDA announced that it will exercise enforcement discretion to allow (1) the exclusion of allulose from the “total sugars” and “added sugars” declarations in the Nutrition Facts Panel, and (2) the use of a general factor of 0.4 calories per gram allulose when determining the caloric contribution of allulose.  FDA will continue to view allulose as a carbohydrate that must be included in the declaration of Total Carbohydrates.  FDA’s determination is based on the agency’s review of information and data submitted in several citizen petitions regarding allulose, as well as FDA’s independent review of the scientific evidence related to allulose and metabolism, caloric value, and dental caries.  FDA states it will exercise enforcement discretion as described above pending the agency’s further review of these issues through rulemaking.  This enforcement discretion applies to both conventional foods and dietary supplements containing allulose.

While the agency has traditionally determined “total sugars” based on chemical structure, FDA explains that due to advances in food technology, some novel sugars may not contribute 4 kcal/g like other traditional sugars.  In light of this, FDA’s current thinking is that the agency should not only consider the chemical structure of sugars, but other factors such as the sugar’s association with dental caries, effect on blood glucose and insulin levels, and caloric contribution, when determining whether a sugar should be included in the declaration of “total sugars,” and by extension, “added sugars” declarations on the label.  The draft guidance signals that the agency may be willing to consider additional factors beyond the chemical structure of a sugar in assessing whether such sugar should be captured in “total sugars” and “added sugars” declarations.

FDA states it considers allulose to be a carbohydrate and it therefore must be included in the “total carbohydrate” declaration.  FDA determined that the “total carbohydrate” declaration captures many ingredients that may not have a significant caloric contribution, and that the calculation method for “total carbohydrate” declarations continues to be appropriate when applied to allulose.  More information can be found at the draft guidance.  See FDA Draft Guidance, The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels, April 2019, available here.

Please let us know if you have any questions regarding FDA’s draft guidance.

 

As a part of the Food and Drug Administration’s (FDA’s) initiative to modernize and reform dietary supplement oversight, FDA announced it will hold a public meeting on responsible innovation in dietary supplement manufacturing on May 16, 2019. FDA also recently unveiled a new Dietary Supplement Ingredient Advisory List, a rapid-response tool intended to quickly alert the public when FDA identifies ingredients that do not appear to be lawfully marketed dietary supplements. FDA has listed four ingredients on the list so far: andarine, higenamine, hordenine, and 1,4-DMAA. This memorandum summarizes these developments.

Click here to read more.

On April 17, 2019, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) issued a proposed rule that would eliminate the requirement that certain packages of meat or poultry products display net weights using the so-called “dual declaration” format (e.g., requiring that some products declare weight in both pounds and ounces). The proposed rule, entitled Rescission of Dual Labeling Requirements for Certain Packages of Meat and Poultry (“Proposed Rule”), would eliminate the dual declaration net weight requirement for meat or poultry products in packages of at least one pound or one pint, but less than four pounds or one gallon.

FSIS issued the proposed rule based on a response to its docket seeking public comments on ways that FSIS could reform its regulatory programs and provide better service to its constituents. The proposed rule reinforces that FSIS is reviewing and acting on some industry recommendations. Companies may wish to consider whether there are additional opportunities for FSIS regulatory reform.

Importantly, this proposed change would be limited to meat and poultry product labels regulated by FSIS. FDA-regulated products would not be affected by this change.

Click here to read more. 

Promoting sustainability and health benefits can lead to legal trouble in the European Union. While the EU is discussing strategies against plastics and a ban on certain single-use plastics, consumers are requesting more sustainability and extra benefits from their consumer products.

When addressing these consumers’ needs, companies should be aware that there are a number of detailed rules restricting “nature-“, “organic-“, “free”-and “health-“claims.

When developing new products, product concepts, and marketing strategies relating to sustainability or health benefits, companies are well advised to check with their legal counsel whether or not a certain product name, trademark, or marketing campaign complies with the relevant provisions and case-law on such claims. Failure to do so could lead to regrettable post launch amendments dictated by local authorities or the courts. The forced rebranding of “Bio-oil” to “Bi-oil” in Germany by court order is just one example.

  • Companies should be particularly thoughtful when making one or more of the following claims. In case of non-compliance with the legal framework, product information, claims and trademarks relating to these benefits could be banned by authorities or courts – with severe consequences e.g. for on-pack promotions or trademark investments.
  • Claims relating to health and/or nutrition benefits may only be used subject to the precondition that they are included in special lists of authorized health and nutrition claims when used for food marketed in the EU. In addition, the conditions and wording set forth in those lists need to be observed. For example, a food marketed in the EU may only carry a reference to vitamin C or a health claim with a wording similar to “Vitamin C contributes to the normal function of the immune system,” if it contains a certain minimum of this vitamin.
  • References to organic, eco(-logical), or bio(-logical) origin or ingredients can only be made for foods marketed in the EU where those foods are produced in compliance with the EU legal framework on ecological farming amended 2018, the new provisions to be observed as of 2021 at the latest. For organic cosmetics, the same rules are applied in parts.
  • When referring to nature or natural claims, companies should be aware that besides certain specific legislation e.g. for natural flavorings in the EU (at least 95 percent by w/w from the source material referred to) there is particularly stringent national case-law allowing nature claims only where a product (i) contains only ingredients consumers naturally expect, (ii) has undergone
    only essential processing, and (iii) shows only ubiquitous pollution.
  • Likewise, free labelling such as “free from GMO” underlies statutory restrictions.

In this year’s edition of Consumer Horizons, the Hogan Lovells global Consumer team identifies trends that will impact food and beverages companies, fashion and luxury goods producers, retailers, consumer electronics manufacturers, and other consumer companies throughout 2019.

Download Consumer Horizons 2019 by registering here.