We have moved our content to the new Hogan Lovells platform Engage. Engage gives you the latest legal and regulatory news and provides insights and analysis for your business, from across our global network, when you need it.

If you have subscribed to this blog, you will receive a launch email for Engage on August 17. However, if you do not receive an email you can register here to continue receiving this content.

We value your loyal readership and look forward to seeing you on Engage!

The Dietary Guidelines Advisory Committee (DGAC) recently released its competed Scientific Advisory Report, which will serve as the basis of the recommendations in the 2020-2025 Dietary Guidelines for Americans. The 2020-2025 Dietary Guidelines for Americans is due to be released by December 2020. This memorandum summarizes several of the major takeaways from the DGAC’s Scientific Advisory Report.

The DGAC findings can be valuable to food marketers in gaining an understanding of the scientific literature underscoring various diet and health relationships. In some cases, the DGAC Scientific Advisory Report (and underlying science) can be a good way to develop claim substantiation. Accordingly, a careful review of the findings in areas of specific interest is recommended. The strengths and limitations of the relevant findings should also be considered in framing nutrition and health claim benefits. To this end, we have found the scientific summaries and references useful in assisting in the development of nutrition and health benefit claims. Stakeholders are also given an opportunity to submit comments.

Click here to read more.

 

Tell me if you’ve heard this one before – the regulatory issues surrounding CBD will be completely resolved after a certain “legislative fix” is passed.  Remember all of the articles in December 2018 declaring CBD legal after the passage of the 2018 Farm Bill? Don’t expect Congress or FDA to wave a magic wand and make all of the current CBD industry practices permissible or adequate.  Even if Congress were to sweep away the exclusionary clause as applied to CBD, or FDA engaged in rulemaking to the same effect – CBD would still need to go through all of the regulatory hurdles applicable to foods or dietary supplements in order to be lawfully used as an ingredient in either product.  Companies intending to market foods or dietary supplements containing CBD should be working right now to address the issues FDA has identified, and working to build the type of robust documentation FDA expects before marketing these products.

Refresher on the Exclusionary Clauses

One of the most pressing FDA regulatory obstacles facing the CBD industry are the so-called “exclusionary clauses” of the Federal Food, Drug, and Cosmetic Act.  In essence, the exclusionary clauses prohibit the use of a substance in a food or dietary supplement if that substance has been the subject of substantial clinical investigations that have been made public, or approved by FDA as a new drug.  There are exceptions to the exclusionary clause; however, FDA takes the view it has not to date been provided with information sufficient to change their current position that CBD is prohibited from use in food and dietary supplements under the exclusionary clauses.

FDA’s interpretation of the exclusionary clauses as applied to CBD is a legal bar preventing FDA from recognizing or regulating CBD as a food or dietary supplement ingredient; however, these provisions have not prevented the CBD marketplace from flourishing.   As a result, the CBD market forged ahead without FDA oversight as part of a premarket authorization review such as the method of manufacture, appropriate specifications, establishment of an acceptable daily intake (ADI), contaminants, labeling, and many other issues.  Many states have begun regulating CBD in foods and dietary supplements, but the state by state approach has led to a patchwork of requirements that is challenging for any company trying to market a product nationally.

Even if Congress passes legislation that removes CBD from the exclusionary clause or FDA establishes a regulatory framework for the lawful marketing of CBD as foods or dietary ingredients, it is expected that any such actions would be conditioned on satisfying FDA’s premarket requirements to use CBD in foods or dietary supplements.  The CBD industry does not have to wait for FDA to say more; there are lessons to learn from FDA’s regulation of foods, dietary supplements, cosmetics, new drugs – and yes, even tobacco products, that can help shape what CBD companies do now.

Food and Dietary Supplement Regulatory Hurdles Still Remain

For foods and dietary supplement uses of CBD, we know the type of data and information that FDA would expect to support the safety of new food and dietary ingredients.  The industry has great success in achieving favorable reviews of GRAS notifications and food additive petitions because the agency expectations on the type of safety data need to support the marketing of the food ingredient are well understood.    Companies interested in the CBD market should be working with food and dietary supplement regulatory counsel and consultants now to assess the underlying data and identify potential data gaps.  FDA has identified several potential safety concerns with CBD, including liver injury, drug interactions, and male reproductive toxicity.  A thoughtfully prepared dossier would address each of these issues and would identify whether additional studies would be warranted—and the type of studies that should be conducted—to addressthe agency’s concerns.¹ FDA also stated that it needs additional information about cumulative exposure, special populations (children, elderly, pregnant and lactating women, adolescents), as well as the effects of CBD on animals before allowing food or dietary supplement uses of CBD.

FDA’s statements suggest that CBD is unlikely to receive special treatment by the agency when being evaluated as a food or dietary supplement ingredient – the same type of data and information required for any other food or dietary ingredient is expected.  And FDA is not alone in raising potential concerns about CBD safety.  A coalition of consumer advocacy groups including Center for Science in the Public Interest (CSPI) recently sent a letter to Congress highlighting FDA’s concerns with CBD, and urging Congress to provide more authority for FDA oversight of CBD products, and that Congress should not shortcut FDA’s review of CBD safety.  Thus we can anticipate that consumer groups, in addition to FDA, will continue to press for the same premarket rules to be applied to CBD as any other food or dietary supplement ingredient.

Beyond satisfying the premarket requirements for foods and supplements, CBD companies should also work with counsel to identify the aspects of their production and marketing of current CBD products that do not fit within FDA’s regulatory framework for that product category.  Special attention should be paid to the claims that are being made about the product.  Foods and dietary ingredients can bear properly substantiated claims regarding the effect of the substance on the structure of function of the body.  Disease claims, however, must be avoided.  Addressing manufacturing and labeling practices that are at odds with FDA precedent now not only puts a company in the best possible position if FDA does greenlight a new regulatory pathway for CBD – it also gives the company credibility.

Next Steps

Accepting FDA regulation and oversight of a budding industry that has been subject to relatively little enforcement is difficult to navigate; just see how bumpy the first four years of FDA’s regulation of e-cigarettes has been for the industry.  It has been over a year since FDA’s public meeting on scientific data and information on cannabis-derived compounds, and yet a number of questions posed by the agency then remain on the table, and time to shape the agency’s view before a regulatory framework is developed could be running out.  Companies that want to be successful long-term in this space should take seriously the concerns raised by the agency and develop regulatory and safety dossiers addressing those concerns and supporting the lawful marketing of their products.


¹ FDA Consumer Update, What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-Derived Compounds, Including CBD, https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis.

On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (Prop 65), proposed to adopt a new regulation that would significantly change the warning requirements for listed chemicals formed by the cooking or heat processing of foods. The proposed regulation would provide that intake of such chemicals does not represent an exposure for the purposes of Prop 65 if the concentrations are reduced to the lowest level currently feasible using appropriate quality control measures. The proposal would establish maximum concentration levels for acrylamide in specific foods that are deemed by OEHHA to be the lowest levels currently feasible. Concentrations of the chemical at or below the level identified for the specified products would not require a warning.

It is noteworthy the proposed regulation is published at a time when a new wave of Prop 65 challenges are targeting acrylamide in food. In the past three months alone, private litigants have filed close to one hundred 60-day notices indicating their intent to sue food companies for acrylamide. This translates to about one Prop 65 notice filed every day in California for acrylamide in food. In its Initial Statement of Reasons, OEHHA stated the proposal is intended to (1) reduce exposures to listed chemicals present in food due to the human activities of cooking or heat processing, (2) provide warnings for avoidable exposures to acrylamide, and (3) safeguard the effectiveness of those warnings.

The public can request a hearing on the proposed changes and the request must be received no later than September 21, 2020. Written comments to the proposed regulation are due on October 6, 2020.

Click here to read more. 

Hogan Lovells is changing how we deliver our food law and policy content. On August 17 we will be moving the A Seat at the Table blog to a new technology platform: Hogan Lovells Engage.

You’ll soon receive an email with details on how to join us on Engage to continue to stay up-to-date on the latest developments in food law and policy. We look forward to seeing you there.

On July 31st 2020, the Interinstitutional Accord between the Ministry of Economy and the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Consumer Protection Federal Bureau (PROFECO) regarding the surveillance activities of the Amendment to the Modification of the Mexican Official Standard NOM-051-SCFI/SSA1-2010, was published on the Federal Official Gazette.

The Interinstitutional Accord mainly provides the following:

  • Non-sanction- From August 1st until November 30th, 2020, manufacturers, importers or marketers will not be sanctioned during the verifications/inspections visits carried out by PROFECO and COFEPRIS regarding those prepackaged foods and non-alcoholic beverages subject to the amendment of the NOM-051 and the Amendment.
  • Previous compliance- A period from August 1st, 2020, to September 30th, 2020, is granted in order for  products that comply in advance with the Amendment of the NOM-051 can be marketed to the final consumers before its entry into force (October 1st, 2020). It should be noted that this exemption is not applicable to importer of record of the products.
  • Extension – A period from October 1st, 2020 to November 30th, 2020, is exclusively granted, so that prepackaged foods and non-alcoholic beverages that complies with the NOM-051 but do not comply with the Front Warning Labeling System (labels and legends) referred in the Amendment can be marketed to the final consumers.

Please be informed, that it is expressly established that neither COFERPIS nor PROFECO will administratively sanction with warnings, fines, closure, arrest, suspension, revocation, cancellation, prohibit immobilization, insurance, withdrawal of the market and/or issuance of alerts, in the terms of the provisions referred above. The Interinstitutional Accord came into effect on August 1st, 2020.

 

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking comments on recommendations to update the List of Bioengineered Foods (List) under the National Bioengineered Food Disclosure Standard (NBFDS). AMS seeks comment on four issues: (1) whether it should add insect-resistant sugarcane to the List; (2) whether it should add the modifier “virus-resistant” to summer squash, which already is on the List; (3) whether additional information is available to support adding cowpea or golden rice to the List; and (4) whether AMS should consider adding any other foods to the List. Comments are due to AMS by August 24, 2020.

Click here to read more. 

The CDC recently released updated its guidance on the criteria for determining when a worker diagnosed with COVID-19 may return to work. The interim guidance, Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (July 20, 2020), is focused on when individuals diagnosed with COVID-19 may end home isolation. It is also incorporated into CDC’s guidance for food companies managing return-to-work requirements for employees and contractors.

Click here to read more.

On July 15, 2020, the Virginia Safety and Health Codes Board passed first-in-the-nation codified emergency temporary standards (the Standards) establishing requirements for employers to control, prevent, and mitigate the spread of SARS-CoV-2 (COVID-19) in the workplace. The Standards were issued at the direction of the Governor to create enforceable regulations. With these Standards, the Virginia Occupational Safety and Health (VOSH) Program will enforce requirements similar in many ways to guidance issued by the U.S. Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA).

Click here to read more. 

The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will begin in March 2021. The IA rule requires food facilities covered by the rule to develop and implement a food defense plan that identifies significant vulnerabilities at actionable process steps and implements mitigation strategies to address those vulnerabilities.

Click here to read more.