The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule).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 (or FDP) 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FDA released the first four chapters of the Draft Guidance in June 2018.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 The second installment of the Draft Guidance provided new content addressing an alternative vulnerability assessment approach, which could be more tailored to a facility by using the three factors in the regulation. The installment also provided guidance on training requirements for individuals performing various tasks under the rule.

This last installment of the IA rule Draft Guidance adds to the previous chapters, covering topics focused on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. 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 final installment in its entirety.

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Please join us on Wednesday, March 11 for the next webinar in our series – A Seat at the Table – What’s new in food law.

The series features updates on the latest news and trends in the food and beverage industry. This session will focus on updates regarding supply agreements, the new nutritional labeling requirements in Mexico, and the latest trends in food deals. Please see below for the program agenda:

The top five provisions to have in a supply agreement

Meryl Bernstein will outline the reasons why it is critical for food and beverage companies to have contractual arrangements with co-manufacturers or co-packers, and why retailers should have clear supply agreements in place with the providers of products they sell in stores.

New nutritional labeling regulations and requirements in Mexico

Cecilia Stahlhut will discuss the main impacts of the new regulations and the new labeling requirements for companies that sell food products in Mexico.

The latest trends in food deals

John Duke will discuss current deal trends in the food and beverage space including how fast-changing consumer demands continue to drive the M&A market.

Click here to register for this complimentary webinar. 

CLE credit is pending state bar approval in New York, California, and Texas

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has released Draft Instructions on Testing Methods (Draft Instructions) for use in compliance with the National Bioengineered Food Disclosure Standard (NBFDS). The document provides guidance on the selection of a test method that may be used to ascertain that a highly refined food or ingredient does not contain detectable modified genetic material and therefore does not require disclosure that the food is bioengineered. The Draft Instructions address selecting a test method that is “fit for purpose”; current DNA-based test methods; emerging technology; selection of a test laboratory; and recordkeeping requirements. Comments on the Draft instructions are due by March 4, 2020, and must be submitted to Docket Number AMS-FTPP-19-0112.

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A recent action by the National Advertising Division (NAD), a self-regulatory arm of the Better Business Bureau, illustrates that advertisers who participate but decline to be bound by an NAD Decision can expect to be referred to the Federal Trade Commission (FTC). The NAD recently announced that it referred advertising claims made by dietary supplement company Creekside Natural Therapeutics (Creekside) to the FTC for further review, following a challenge by the Council for Responsible Nutrition (CRN).

Voluntary Process Backed by Prospect of FTC Referral

The NAD is a voluntary industry dispute resolution body and a division of the Better Business Bureau. NAD provides a forum by which competitors or others can challenge advertising largely on the question of what claims are conveyed and if the advertiser has appropriate substantiation.

Once a dispute is initiated at NAD, should the challenged advertiser choose to participate, both parties submit briefs in writing and meet with the NAD before it issues a formal written decision. If recommendations for changes to advertising are made by NAD, the advertiser must state whether it “(1) agrees to comply with NAD[‘s] recommendations, or (2) will appeal all or part of NAD[‘s] decision to the [National Advertising Review Board (NARB)].” Indeed, NAD procedures require that the Advertiser’s Statement (that appears with the final Decision) initially state whether the Advertiser accepts NAD’s recommendations or will file an appeal. Advertisers who fail to submit an Advertiser’s Statement are treated as having declined to comply and may be referred to the FTC for further review and potential enforcement. Several FTC enforcement actions were initiated from an
NAD referral.

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On 15 January 2020, President Donald J. Trump and Chinese Vice Premier Liu He signed a “Phase One” Agreement between the United States and China, a truce halting the escalating trade tensions between the two global trading heavyweights. The Phase One Agreement follows an investigation by the Office of the United States Trade Representative (USTR) into Chinese trade practices that culminated in substantial and expansive U.S. tariffs on more than US$350 billion worth of Chinese exports to the United States. The Agreement is scheduled to become effective on 14 February 2020.

The Phase One Agreement includes commitments by China, including: (1) purchasing an additional US$200 billion in U.S. goods (manufactured, agriculture, and energy) and services, compared with baseline Chinese purchases in 2017; (2) introducing sectoral reforms, including improved intellectual property protections; (3) prohibiting forced technology transfers; (4) removing barriers to U.S. agricultural imports; and (5) liberalizing financial services. The Agreement also includes a commitment to cooperate on macroeconomic policy and exchange rates.

The Phase One Agreement addresses certain U.S. priorities, such as trade secrets, pharmaceutical patents, forced technology transfers, market access for U.S. agricultural and financial services products, and other longstanding U.S. concerns about intellectual property rights. Notwithstanding, U.S. tariffs remain in effect on more than US$350 billion worth of Chinese goods, and several systemic issues were put off for a phase two agreement. Accordingly, while potentially significant, the Phase One deal should be viewed as a short-term truce until the parties attempt to resolve more challenging systemic issues. In addition, the deal rests heavily on China’s implementation of its specific terms – in order to enforce the parties’ commitments, the deal contains an innovative “dispute settlement arrangement,” permitting either party to impose additional tariffs if consultations do not produce a solution.

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The use of hemp for the production of foodstuffs is contemplated by the Law No. 242 of 02 December 2016 (Law 242/2016), bearing provisions for the promotion of the hemp cultivation and of the agro-industrial hemp chain in Italy.

The use of hemp for the production of foodstuffs is contemplated by the Law No. 242 of 02 December 2016 (Law 242/2016), bearing provisions for the promotion of the hemp cultivation and of the agro-industrial hemp chain in Italy.

As noted in an earlier comment (see our recent comment here), the Law 242/2016 does not contain a regulation on the admitted THC content in food, while referring to the implementing regulation of the Ministry of Health. When the Law 242/2016 entered in force no THC was admitted in food.

On January 15, 2020, a decree issued by the Ministry of Health set the maximum amount of THC that is allowed in food (hereinafter THC Decree) and provided guidance on the appropriate method of analysis.

The THC Decree

The THC Decree sets forth a list of hemp food products (Annex I) that are in the scope of the new regulation. These are the seeds (including mashed and ground seeds other than flour) and hemp-derived ingredients that are obtained from seeds, i.e. flour and oil.

Hemp food products listed in Annex I may be placed on the market upon the condition that the THC content does not exceed the following thresholds set out in Annex II:

  • seeds and flour: 2.0 mg total THC on 1 kg of product;
  • oil obtained from hemp seeds: 5,0 mg total THC on 1 kg of product;
  • food supplements containing ingredients derived from hemp: 2,0 mg THC total on 1 kg of product.

Total THC (tetrahydrocannabinol) is defined in the THC Decree as the concentration resulting from the sum of the concentrations of the substance “Δ9 -THC ((-)-trans- Δ9 -THC)” and the non-active acid precursor “Δ9 -THCA-A (delta-9-tetrahydrocannabinolic acid A)”.

As far as the controls are concerned, the sampling must be performed in accordance with Regulation (EC) No 401/2006, while the analysis should be carried out according to the Commission Recommendation (EU) 2016/2115 of 1 December 2016 on the monitoring of the presence of Δ9-tetrahydrocannabinol, its precursors and other cannabinoids in food.

The list of hemp food products in Annex I should not be regarded as exhaustive. Other hemp food products could be placed on the market, as it is made clear by Article 5(2) of the THC Decree. However, hemp food products that are not listed in Annexes I and II of the THC Decree do not benefit from the tolerance thresholds of the THC Decree and must instead comply with Regulation (EC) No. 1881/2006 of 19 December 2006, setting maximum levels for certain contaminants in foodstuffs.

Mutual recognition

The THC Decree includes a mutual recognition provision, according to which hemp-based food products legally marketed in another state of the European Economic Area or in Turkey may be commercialized in Italy. While this may open the door to the introduction in Italy of products that may have a higher THC content, it must be added that the importation is anyway subject to the Regulation (EC) No 764/2008, laying down procedures relating to the application of certain national technical rules to products lawfully on the market in another member state. This allows a member state to require the compliance with a national technical regulation if certain conditions are met. As a consequence, the room for the commercialization of hemp food products whose THC content materially diverge from Italian law could be limited.


Some commentators welcomed the THC Decree as a liberalization of the use of hemp in food. However, at a closer look, this conclusion proves not to be justified. Indeed, from the one hand, foodstuffs that are listed in the THC Decree are essentially those that have always been on the market in Italy (flour and oil obtained from seeds) as considered THC free due to the starting materials used. On the other hand, the minimum THC content levels that are now set forth in the THC Decree refers to a THC presence in traces. This is in line with the Law 242/2016 that authorized the Ministry of Health to determine the THC “residues” in food and not actually the sale of food products with THC content. Indeed, the THC thresholds remain very restrictive for producers. In percentage, the THC limits are set at 0.0002% (for seeds, flour and food supplements containing food derived from hemp), and at 0.0005% for oil obtained from hemp seeds.

The new regulation is nonetheless helpful for the development of the hemp industry in Italy. The determination of THC residues that can be accepted in food and the method of analysis for the THC detection are key aspects for setting a clear legal framework and reduce the risk of potential liabilities.

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued an updated Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not Used in Meat, Poultry, Or Egg Products (Guideline). The updated Guideline clarifies that FSIS will approve negative claims verified under a third-party certifying organization the same way it approves other special statements or claims and will not limit claims to those consistent with the Agricultural Marketing Service’s (AMS’s) definition of “bioengineering.” FSIS also added information about labeling for certified organic products. This memorandum provides background on the Guideline and summarizes the changes FSIS made in response to comments received after the initial Guideline was released in August 2016.

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On December 31, 2019, the U.S. Food and Drug Administration (FDA) issued two final guidance documents to assist industry with compliance with the agency’s updated Nutrition Facts labeling regulations. The first final guidance, entitled, “Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics” is a questions-and-answers style document and a helpful resource to consult for determining the serving size, number of servings, and appropriate Nutrition Facts Panel (NFP) format for different types of food packages. This guidance finalizes the draft guidance released in November 2018 with relatively few changes, as summarized below. FDA also updated one question in its final guidance document, “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals,” with a new question-and-answer on the creation of sugars through the controlled hydrolysis of starch and other complex carbohydrates in the production of plant-based beverages, as discussed further below.

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The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued a revised compliance guideline for substantiating animal raising claims on labels for meat and poultry products. This updated guideline expands and, in some cases, modifies FSIS’s written policies on animal raising claims made on meat and poultry products. The guideline addresses both how claims should be phrased (including necessary qualifiers or explanatory text) and what type of information the establishment must include with the label application. Although FSIS policy has remained generally consistent at a high level from the previous guideline, FSIS has indicated that it expects certain claims to include additional or updated explanatory statements. It will be important for companies making animal raising claims to review their current labels and claims to evaluate whether changes will be required and to determine an appropriate process for doing so. Companies should revisit point-of-sale claims (regulated by FSIS but not subject to preapproval) and advertising (not regulated by FSIS but assessed by the Federal Trade Commission’s deceptive advertising standard) in light of the revised compliance guidelines.

Animal raising claims, which include statements about antibiotic use, specialty feeds or diets, caging and handling, animal welfare claims, and other husbandry issues, are becoming increasingly popular on labels and point-of-sale retail labeling. Animal raising claims are considered “special statements or claims” that trigger prior review and approval by FSIS. The updated compliance guideline expands on the September 2016 version of the guideline. The revisions will be of interest to meat and poultry processors, retailers, and restaurants making these types of claims. Compliance guidelines are technically nonbinding documents, but they explain FSIS’s current thinking and effectively represent the policies applied when the Agency reviews and approves labels bearing these claims. FSIS is accepting comments until February 25, 2020.

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The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking public comment on draft instructions to validate a refining process under the National Bioengineered Food Disclosure Standard (NBFDS). Validated refining processes can be used to demonstrate a food does not contain detectable modified genetic material and therefore does not require a disclosure under the NBFDS.  AMS released the document prior to the holidays and only provided a 30 day comment period. Comments on the draft instructions are due by January 16, 2020.

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