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.

The Consumer industry is evolving at lightning speed, and the way consumer companies operate is shifting. From issues in supply chain to the digitalization of the consumer experience, companies are rapidly changing to keep up with consumer demands. Last year businesses in the consumer industry saw a wave of unprecedented disruption and transformation, and 2019 promises challenges of similar or greater magnitude.

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.

Our team breaks down disruptive technology, sustainability and corporate responsibility practices, privacy and consumer data issues, shifting sales models, supply and sourcing matters, M&A and capital markets, and more – all with a look at global perspectives.

Food-related developments include:

Download Consumer Horizons 2019 by registering here.


For further information, please visit our Consumer Industry page on HoganLovells.com.

The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise  enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing, and holding almonds, pulse crops, wine grapes, and hops. FDA received feedback from these entities that they should be exempt after it issued the final Produce Safety rule, and FDA is  exercising enforcement discretion while it considers pursuing rulemaking to address the challenges each of the commodities presents. Comments on the Guidance may be submitted at any time. This action is part of FDA’s continued implementation of the FDA Food Safety Modernization Act (FSMA).

Click here to read more.

This post summarizes several regulatory developments related to cannabis and cannabisderivatives, including cannabidiol (CBD). The Food and Drug Administration (FDA) recently announced it will hold a public meeting on May 31, 2019 and open a docket for public comments to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. FDA, in coordination with the Federal Trade Commission (FTC), also issued three Warning Letters to companies marketing CBD products positioned as foods and dietary supplements. The Warning Letters explain that FDA determined these products are unapproved new drugs, while the FTC indicated that efficacy claims appearing in these products’ advertising may not be substantiated by competent and reliable evidence. Finally, California’s Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed to include THC and “cannabis extracts” on the Proposition 65 list of developmental toxicants. We discuss each of these developments in further detail.

Click here to read more.

Vegan and vegetarian food is becoming more and more popular. However, as a lot of vegans and vegetarians are not willing to give up the taste of meat the demand for meat substitutes increases. Whether “vegan salami” or “vegetarian meatballs”, the fundamental question regarding the designation of those substitutes remains unclear so far: Is the current practice of designating them in the same way as the conventional meat products misleading consumers and should such designations be reserved for the “original”?

At the end of 2018, the German food book Commission (Deutsche Lebensmittelbuchkommission) published new guidelines for vegan and vegetarian food. These new principles reflect manufacturing and commercial practices as well as consumer expectations, in particular with respect to vegan and vegetarian food products that have a sensory similarity to products from animal origin.

Click here to read more. 

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand food safety monitoring. The statement details how FDA would use requested funds, if provided by Congress, to build a “smarter, more technologically advanced food safety system” that “stands on the shoulders of the preventive framework” of the FDA Food Safety Modernization Act (FSMA). Below we highlight four key aspects of the funding request: (1) state inspection partnerships, (2) imported food inspections, (3) enhanced response to outbreaks of foodborne illness; and (4) premarket safety review of new food ingredients, including those utilizing genome-editing under the agency’s Biotechnology Innovation Action Plan.

Click here to read more. 

The National Academies of Sciences, Engineering and Medicine (NASEM) recently released updated Dietary Reference Intakes (DRIs) for sodium and potassium. For the adequate intake of sodium, the report reaffirms the existing 1,500 mg level for individuals ages 14-50, establishes a lower level for children age 1-13, and sets a higher level for adults ages 51 and older.  For the adequate intake of potassium, the report establishes a significantly lower level for all populations except infants.  The report also assigned a Chronic Disease Risk Reduction (CDRR) level for sodium of 2,300 mg for most populations.  This is the first time a CDRR has been assigned to a nutrient.  In contrast to the CDRR, which represents the level above which intake reduction is expected to reduce chronic disease risk within an apparently healthy population, the report explains that the Tolerable Upper Intake Level (UL) now refers to toxicity.  NASEM found insufficient evidence of risk of toxicity from excess sodium or potassium, so a UL was not set for either nutrient.

Click here to read more. 

Recently, an interdisciplinary team from our IPMT and Food Regulatory practices discussed a pending proposed rulemaking from the Alcohol and Tobacco Tax and Trade Bureau (TTB), the primary federal agency that regulates alcohol beverages. On November 26, 2018 TTB proposed modernizing its labeling and advertising regulations with the goal of making the current regulations simpler and clearer for business owners so that compliance will be easier for industry members.

The original deadline for public comment was March 26, 2019, but TTB just extended this deadline until June 26, 2019. Don’t miss out on the opportunity to participate in a major regulatory revision concerning alcohol beverage products.

Click here to read the original article and to discover some of the top takeaways from the proposed regulation.

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and they must take steps to ensure those mitigation strategies are working.

FDA released the first four chapters of the Draft Guidance in June 2018. Those chapters (1) provided templates for various components of a food defense plan, (2) addressed how to develop a food defense plan, including one particular method for conducting a vulnerability assessment to identify significant vulnerabilities and actionable process steps (the Key Activity Type (KAT) method), and (3) included information regarding mitigation strategies for actionable process steps and monitoring.

The second installment of the Draft Guidance adds to and incorporates the previous chapters, also providing new content addressing a vulnerability assessment approach. This approach can be more tailored to a facility by using the three factors in the regulation and provides guidance on training requirements for individuals performing various tasks under the rule. This memorandum provides an overview of the new material, and is by no means a comprehensive summary. We encourage food facilities covered by the IA rule to read the second installment in its entirety.

Click here to read more. 

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of imported foods. The Strategy sets out four food safety goals: 1) preventing food safety problems in the foreign supply chain prior to entry; 2) detecting and refusing entry of unsafe foods at the border; 3) quickly responding to unsafe imported food; and 4) developing and publishing metrics to monitor FDA progress.

This blog post provides an overview of the agency’s strategy, explains the guiding principles behind this strategy, and summarizes the methods the agency plans to use to accomplish its four goals.

Click here to read more.