Today the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name for “potassium chloride.” Potassium chloride is often used as a partial substitute for sodium chloride (i.e., salt) to facilitate sodium reduction in foods. FDA therefore views today’s draft guidance as consistent with its multi-year Nutrition Innovation Strategy, which aims to reduce the burden of chronic disease through improved nutrition, as well as the agency’s efforts to encourage manufacturers to reduce sodium in foods in the interest of public health. FDA will accept comments on the draft guidance until July 19.

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The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019 Memo, effective on May 11th, “reinforces the obligations of Federal agencies” under the Congressional Review Act (CRA) to submit rules to Congress, and also clarifies when a rule is to be considered “major” by OMB’s Office of Information and Regulatory Affairs (OIRA). The criteria and process the 2019 Memo sets for triggering OIRA “major” designation are the more significant aspect of the document, as they have the potential to noticeably impact FDA issuance of guidance documents.

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We are writing this memo to bring to your attention that the Food and Drug Administration (FDA) recently published a new final guidance titled: “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk” (FCN Guidance). The guidance contains recommendations regarding how the scientific information in food contact notifications (FCNs) for infant food use should demonstrate that the food contact substance (FCS) is safe for the specific intended use in contact with infant food. FDA has previously provided guidance for the safety assessment of FCSs. However, the earlier guidance document did not specifically address dietary exposure and safety assessment considerations related to the migration of chemical substances from packaging and other food contact articles as it pertains to infants. FDA meant to fill the gap with this new guidance and the FCSs that would be affected by this guidance document include infant formula packaging for liquid and powdered formula, baby bottles, bottle inserts, nipples, and any other materials that are in contact with infant food.

In this post, we highlight the FDA’s chemistry and toxicology recommendations. Click here to read more. 

On May 31, Hogan Lovells will offer an important training program on conducting a vulnerability assessment under the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule), which is part of the FDA Food Safety Modernization Act (FSMA). This 1-day workshop will deliver the standardized “Conducting Vulnerability Assessments” training curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA) with input from FDA.

The course will be taught by Hogan Lovells partners Elizabeth Fawell and Maile Hermida from 8:30 a.m. to 4:30 p.m. on Friday, May 31. Breakfast will be served at 8 a.m. It will be held in the Hogan Lovells office at 555 13th Street NW, Washington, D.C. 20004.

Click here to register for this training program. 

Who should attend this training?

Personnel from facilities and companies covered by the IA rule that want to understand how to conduct a vulnerability assessment using the three fundamental elements method or the “hybrid” method (which combines the Key Activity Type (KAT) method with the three fundamental elements method).

Participants will:

  • Learn in-depth about how to conduct a vulnerability assessment, including recommended preliminary steps, using the three fundamental elements and the “hybrid” approach.
  • Understand the role of the vulnerability assessment in the food defense plan.
  • Engage in interactive discussions and exercises to enhance your understanding of how to conduct a vulnerability assessment.
  • Review useful forms, templates, and resources for conducting vulnerability assessments.

Why attend the Hogan Lovells course?

  • Elizabeth Fawell and Maile Hermida have substantial FSMA experience and have been working on these issues since even before FSMA was enacted. In particular, they have been deeply engaged on the IA rule and how facilities can comply with its requirements for several years. Elizabeth was also one of the few Trainers of Trainers for this training program, reflecting her comprehensive expertise.
  • Based on our experience with an understanding of existing food defense plans across the food industry, we can explain where companies need to revise their programs to be FSMA compliant and how to comply with the rule in a practical way.
  • Participants who successfully complete the program will receive the FSPCA’s course completion certificate.

What are the compliance dates?

  • July 26, 2019, is the compliance date for companies with more than 500 full-time-equivalent (FTE) employees.
  • July 27, 2020, is the compliance date for companies with less than 500 FTE employees.

​ Cost

US$800 for each participant.

Additional notes

  • The training program offers legal information, but will not provide legal advice specific to any company’s IA compliance.
  • Participants are encouraged, though not required, to take the online course “Conducting Vulnerability Assessments Using the Key Activity Types” before attending this course. You can access the course here.
  • The IA rule requires that individuals conducting or overseeing the conduct of a VA “have successfully completed training for the specific function at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to conduct the activities” (21 CFR 121.4(c)(2)). This training developed by the Food Safety Preventive Controls Alliance (FSPCA) is the “standardized curriculum” recognized by FDA.  Successfully completing this course is one way to meet this requirement.  Therefore, completing this course is not mandatory for regulatory compliance; however, it will help you understand what you need to do to comply.
  • This training is open to non-firm clients.

Click here to register for this training program. 

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.