Please join us at 2 p.m. on Tuesday, February 26 for a webinar on the regulatory landscape for hemp-derived products, including cannabidiol, or CBD.

Martin J. Hahn and Samantha Dietle will provide an overview of the impact that changes to the Farm Bill will have on the FDA regulation of hemp and hemp-derived ingredients, as well as the Food and Drug Administration’s authority to regulate the use of hemp-derived ingredients in FDA-regulated foods, dietary supplements, and cosmetics.

Delia A. Deschaine will explore the Drug Enforcement Agency’s historical regulation of cannabis-derivatives under the Controlled Substances Act and the unique issues presented by the development of cannabis-derivatives as approved new drugs under the DEA’s and FDA’s authority.

Please click here to register for this complimentary webinar. 

The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when the new regulations were published, correct errors in FDA’s sample Nutrition Facts Panel (NFP) and Supplement Facts Panel (SFP) formats, and update cross references that were not updated when the new rules were issued. This post highlights the key changes affected by the technical amendments.

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The California legislature has passed a law amending the state’s slack-fill statute for food containers subject to the Federal Food, Drug and Cosmetic Act (FFDCA). Assembly Bill 2632 (AB 2632), which Governor Jerry Brown signed into effect on September 19, 2018, revises the slack-fill statute by creating four new so-called “safe harbor” provisions, under which empty space in a container is not considered nonfunctional slack-fill. These new safe harbor provisions provide additional clarity on the types of food packages that will not be considered to contain nonfunctional slack-fill and may provide some relief to the food industry from the recent surge in purported class law suits seeking damages for allegedly slack-filled packaging. This memorandum summarizes the changes to the state slack-fill statute.

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The U.S. Food and Drug Administration (FDA) last month announced it would exercise enforcement discretion over two qualified health claims characterizing the relationship between the reduced risk of coronary heart disease (CHD) and the consumption of oleic acid in edible oils (containing at least 70 percent of oleic acid per serving) when consumed in place of saturated fats (SFA). Oleic acid is the most common monounsaturated fatty acid (MUFA) and can be found naturally in numerous food sources, including edible oils, meat, cheese, nuts, seeds, eggs, pasta, milk, olives, and avocados. Oleic acid has been used as food or as components of food, such as olive oil, by man for many years, and has been approved as a direct additive to foods.

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The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance addressing the compliance date, added sugars definition, and quantitative declarations of vitamins and minerals.1 The draft guidance is focused on the serving size, Reference Amounts Customarily Consumed (RACCs), and determining the appropriate Nutrition Facts Panel (NFP) format, including dual-column labeling.

This post summarizes the major highlights of the guidance documents, particularly where FDA has offered interpretations not found directly in the final rules. All food companies should consult FDA’s new guidance documents as they continue to implement the new nutrition labeling requirements before the January 1, 2020 compliance date.

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The U.S. Food and Drug Administration (FDA) recently issued a request for information seeking data and other information on the prevalence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing foods in the marketplace that are not currently required to disclose the presence of sesame. FDA is collecting this data to inform potential rulemaking that could require food labels to disclose the presence of sesame as an allergen in order to protect and promote public health. In addition, FDA will use this data to respond to a Citizen Petition submitted by the Center for Science in the Public Interest (CSPI) requesting that FDA issue a regulation to require sesame to be labeled as an allergen in the same manner as the eight major food allergens under the Food Allergen Labeling and Consumer Protection Act (FALCPA).

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On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined that these additives do not pose a risk to public health under the conditions of their intended use. The agency acknowledges that these flavorings and adjuvants are used in very small amounts and their use results in very low levels of exposures and low risk. Nonetheless, in light of the animal data showing carcinogenicity, the agency concluded it had to withdraw their authorization as food additives as a matter of law under the Delaney clause. FDA intends to enforce the Rule’s requirements only on products manufactured after October 9, 2020, containing one or more of the six synthetic flavoring substances.

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Last week, the California Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed an amendment to the existing regulation requiring: (1) the average concentration of a listed chemical as causing reproductive toxicity (e.g., lead) be based on products from the same manufacturing facility; and (2) the dietary exposure to a listed chemical as causing reproductive toxicity be calculated using the arithmetic mean. If adopted, the proposed changes would overrule the court decision in Environmental Law Foundation v Beechnut Nutrition Corp on how to determine the daily intake of listed chemicals as causing reproductive toxicity. The change could impose additional testing requirements on the industry and could create a more rigid standard for falling within a safe harbor. We encourage food companies to evaluate whether the proposed changes would adversely impact their current Proposition 65 compliance positions.

Comments to the proposed regulation are due by November 19, 2018. In addition, a public hearing on the proposed amendment would be scheduled on request. To request a hearing, OEHHA needs to be notified no later than November 5, 2018.

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The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based products. This action arose from the agency’s Nutrition Innovation Strategy, one tenet of which is a focus on modernizing food standards. During Commissioner Gottlieb’s remarks at the Nutrition Innovation Strategy public meeting, he stated that requests for the agency to take a closer look at the dairy standards of identity is one of many reasons why FDA is interested in modernizing the food standards, and that this would be the first area in which FDA is going to have an active public process for reviewing the standards and how consumers understand the use of terms like “milk” on both animal-derived and plant-based products.

This RFI aims to gather information on how consumers use plant-based products and how consumers understand the use of dairy terms, such as “milk,” or “yogurt” when they appear on the labels of plant-based products, as well as the nutritional attributes of these products and how these products can help consumers meet the recommendations in the Dietary Guidelines for Americans.

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In the final batch of technical notices, the UK Government has provided guidance on what impact traders can expect on food labelling and packaging in the event that the UK exits the EU without a Withdrawal Agreement on 29 March 2019.

Currently, EU rules, such as EU Regulation 1169/2011 or “FIC”, govern food labelling and minimum compositional standards (with some exceptions) for foods in the UK. As explained in a previous blog, from 29 March 2019, these EU-based rules will be absorbed into English law as part of the Withdrawal Act and adapted where necessary by way of statutory instruments to ensure they apply as intended. There will however be a number of additional changes required to food labels to reflect the fact that the UK will no longer be a member of the EU.

Click here to read more.