FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule).  This is the first of three installments of guidance the FDA plans to release related to the IA Rule.

The new guidance covers the development of a food defense plan, which includes the following:

  • Vulnerability assessment: an assessment that identifies vulnerabilities in a facility’s food manufacturing processes and provides actionable process steps, which are places in the process where a facility can implement mitigation strategies to minimize or prevent the vulnerability;
  • Mitigation strategies: strategies that significantly minimize or prevent significant vulnerabilities at actionable process steps;
  • Food defense monitoring procedures: procedures, including the frequency with which they are to be performed, for monitoring mitigation strategies to assess whether mitigation strategies are operating as intended;
  • Food defense corrective action procedures: actions taken if the mitigation strategies are improperly implemented based on the nature of the actionable process step and the mitigation strategy; and
  • Food defense verification procedures: verification activities to ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.

This guidance covers the vulnerability assessment, mitigation strategies, and food defense monitoring procedures. Remaining FDA guidance will cover food defense corrective actions, food defense verification, reanalysis, and recordkeeping. Continue Reading

Senator Schumer Introduces Legislation to Decriminalize Marijuana at the Federal Level

Making good on this April 20th announcement, Senator Chuck Schumer (D-NY) introduced legislation that would upend current federal regulation of marijuana. Specifically, the Marijuana Freedom and Opportunity Act removes marijuana from the list of scheduled substances under the Controlled Substances Act, effectively decriminalizing it at the federal level.  Under the bill, states would continue to have individual authority to regulate marijuana but federal authorities would be able to prevent trafficking between states where the substance is legal to where it is not and to oversee advertising to the extent necessary to prevent targeting ads to children.  Co-sponsors include Senators Bernie Sanders (I-VT), Tim Kaine (D-VA) and Tammy Duckworth (D-IL).

Highlights of the proposed legislation, per the Fact Sheet, include the following:

  • Decriminalize Marijuana: The legislation would decriminalize marijuana at the federal level by descheduling it, which means removing marijuana from the list of scheduled substances under the U.S. Controlled Substances Act of 1970;
  • Respect States’ Rights: The legislation would maintain federal law enforcement’s authority to prevent marijuana trafficking from states that have legalized marijuana to those that have not;
  • Level The Economic Playing Field: The legislation would establish dedicated funding streams to be administered by the Small Business Administration (SBA) for women and minority-owned marijuana businesses that would be determinant on a reasonable estimate of the total amount of revenue generated by the marijuana industry;
  • Ensure Public Safety: The legislation would authorize $250 million over five years for targeted investments in highway safety research to ensure federal agencies have the resources they need to assess the pitfalls of driving under the influence of THC and develop technology to reliably measure impairment;
  • Invest In Public Health: The legislation would invest $500 million across five years for the Secretary of Health and Human Services to work in close coordination with the Director of National Institutes of Health (NIH) and the Commissioner of Food and Drug Administration (FDA) in order to better understand the impact of marijuana, including the effects of THC on the human brain and the efficacy of marijuana as a treatment for specific ailments;
  • Protect Children: The legislation would maintain the Department of Treasury’s authority to regulate marijuana advertising in the same way it does tobacco advertising to ensure the marijuana businesses aren’t allowed to target children in their advertisements. The bill also allows the agency to impose penalties in the case of violations;
  • Incentive sealing and Expungement programs: The legislation authorizes grant programs to encourage state and local governments to administer, adopt, or enhance expungement or sealing programs for marijuana possession convictions. The bill provides $100 million over five years to the DOJ to carry out this purpose.

Continue Reading

FDA to Hold Public Meeting on Foods Produced Using Animal Cell Culture Technology

The FDA recently announced that it will hold a public meeting entitled, “Foods Produced Using Animal Cell Culture Technology,” on July 12, 2018 to provide the public with an opportunity to offer feedback related to the production of foods using animal cell culture technology.  Stakeholders will also have the opportunity to submit written comments until September 25, 2018.

The agency indicated that it intends to “share our initial thinking for how we intend to appropriately apply our existing regulatory tools and policies to this novel area of technology.”  The agency specifically asked for input, relevant data, and information related to certain questions, such as:

  • The kinds of variations in manufacturing methods that would be relevant to the safety of such products when consumed as foods;
  • The kinds of substances used in the manufacture of foods produced using animal cell culture technology;
  • Potential hazards associated with the production of such foods and the need for unique control measures to address potential hazards.

While this meeting will be focused on food safety issues, the notice noted that the agency “recognizes the importance of other issues . . . , such as labeling, and FDA welcomes comment on these other issues and expects that they will be the focus of future engagement with stakeholders and the public.”  Interested parties can register for the meeting here or submit comments on the docket here.

Let The People Decide: President Trump Expresses Support for Bill To Protect State Regulation of Marijuana

Earlier this week, U.S. Senators Cory Gardner (R-Colo.) and Elizabeth Warren (D-Mass.) and U.S. Representatives David Joyce (R-Ohio) and Earl Blumenauer (D-Ore.) introduced the bicameral, bipartisan Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act). The purpose of the proposed Act is to protect the rights of individual states, the District of Columbia, U.S. territories, and federally-recognized tribes to regulate marijuana within their respective borders.

The introduction of this bill follows the rescission of a DOJ policy known as the Cole Memo, which was Obama-era guidance to federal prosecutors regarding marijuana enforcement. As we wrote here, rescission of the Cole Memo was characterized as an effort to restore prosecutorial discretion, albeit one that was made while also casting marijuana as a contributor to “the growing drug crisis.”  Attorney General Sessions has been vocal in his opposition to marijuana legalization and the change in policy prompted concern by many that the burgeoning industry would be targeted. 

In response to potential new enforcement, Colorado Senator Cory Gardner announced that he would block all DOJ nominations.  Colorado made recreational marijuana legal in 2014 by voter referendum, the same mechanism used in several other states where marijuana is legal.

Contrary to his attorney general’s support for federal marijuana enforcement, President Trump has reportedly given assurances to Senator Gardner that Colorado’s cannabis industry would not be impacted by the rescission of the Cole Memo. Most recently, as reported by Politico, President Trump expressed support for the STATES Act and indicated that he expects that he will sign it.

What’s Likely To Happen.  Like any piece of legislation, the bill will undergo debate and markup and may look very different when and if it is eventually brought up for a vote.  Also, the President does have a documented history of expressing support for a position and changing his mind the following week.  Notwithstanding, marijuana legalization remains popular with voters and leaving the issue to the states would be consistent with the President’s support for states’ rights generally.

For industry, it seems increasingly possible that the rescission of the Cole Memo was a unifying catalyst rather than a threat. Stay tuned here for updates on the STATES Act and our upcoming post on the real impact of the rescission of the Cole Memo.

USDA and FDA Announce Proposed Bioengineered Disclosure Rules and Labeling Rule Compliance Date Changes

Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4, the Agricultural Marketing Service (AMS) of the USDA proposed a rule regarding the National Bioengineered Food Disclosure Standard providing labeling requirements for disclosing whether a food product has been bioengineered.

The proposed rule applies to specific food products: (1) those foods that meet the definition of “food” under the federal Food, Drug, and Cosmetic Act (FDCA); and (2) foods that are subject to Federal Meat Inspection Act, Poultry Products Inspection Act, or the Egg Products Inspection Act, if those foods’ most predominant ingredients would be subject to the FDCA requirements, or its most predominant ingredient is a broth, stock, water, or something similar, and the second-most predominant ingredient is subject to the FDCA. An example would be a chicken pasta soup where chicken broth is the most predominant ingredient, and pasta is the second-most predominant ingredient.

AMS has identified specific products that would be subject to the rule, based on their presence in the United States market. Foods such as field corn and soybeans that are known to be largely bioengineered and have been highly adopted in the United States. will require a bioengineered disclosure, as will products made from those foods, such as corn meal and soy sauce. Other foods, such as sweet corn and summer squash, are not as highly prevalent in bioengineered forms in the United States and thus have different labeling requirements. However they still require some type of bioengineered disclosure.

Under the proposed rule, disclosure requirements would not be triggered by the use of incidental additives that are made from bioengineered organisms, or food derived from animals that consumed bioengineered feed. In addition, the proposed disclosure requirements would not apply to  food that the USDA has certified as organic.

AMS has proposed a variety of options in terms of how the products can be labeled, and has provided a few different design options as well. Some examples are below:

These labeling requirements are proposed to go into effect on the same dates as the updated FDA labeling rules. For more information about the proposed rule, see our client advisory here.

Comments on this proposal will be accepted until July 3, 2018. AMS does not intend to extend the comment period beyond this date. AMS must provide a final rule by July 29, 2018.

On the same day, the FDA provided a final rule extending the date for required compliance for the final rules for the Nutrition Facts Label and Serving Size Label. Manufacturers that have more than $10 million in annual food sales have an extension from July 26, 2018 to January 1, 2020, and manufacturers with less than $10 million in annual food sales have an extension from July 26, 2019 to January 1, 2021.


House Committee Considers Blockchain to Improve Supply Chains and Combat Counterfeiting

A subcommittee of the House Committee on Science, Space, and Technology held a hearing this week to examine the use of blockchain technology to improve supply chains and combat counterfeiting. If you’re like many people, you may have heard of blockchain technology but you’re still figuring out what it is and how it’s used.  There are lots of explanations out there, but here’s one from Forbes magazine that we think is fairly understandable:

“[A] blockchain can be described as an append-only transaction ledger. What that means is that the ledger can be written onto with new information, but the previous information, stored in blocks, cannot be edited, adjusted or changed. This is accomplished by using cryptography to link the contents of the newly added block with each block before it, such that any change to the contents of a previous block in the chain would invalidate the data in all blocks after it.”   By being decentralized and available to all participants, it creates accountability and transparency among all parties.

Putting this into a practical example, large food companies are using blockchain technology to track produce grown in Asia, trucked to a processing facility, shipped to the U.S., and stored and distributed throughout the country. Each step is recorded in the blockchain, creating a more transparent and, hopefully, reliable supply chain.  Since a supply chain is essentially a series of contracts, legal questions abound about how to sort out the parties, the governing standards, the remedies if the purpose of the contract isn’t achieved, dispute resolution, privacy, etc.

To examine some of these issues, the House Science Committee convened the following logistics and security stakeholders:

Key Points From the Witnesses Were As Follows:

  • Department of Homeland Security is partnering with industry to see if it can set standards for the supply chain process.  U.S. Customs and Border Protection, are currently conducting blockchain pilots with industry to see how the technology could be used to combat counterfeit products and intellectual property theft.
  • UPS and Maersk highlighted blockchain’s ability to verify transactions across distributed ledger could revolutionize the intricacies of the global shipping system, allowing them to trace counterfeit products and provide end-to-end visibility into the supply chain.
  • Both Maughan and the industry witnesses also called for the continued cooperation of federal and international partners to help craft blockchain standards agreements.
  • Blockchain could reduce fraudulent goods coming from overseas using American products without licenses in order to undercut domestic businesses.

For anyone interested in the full hearing transcript, it can be found here.

FDA Finalizes Guidance on Newly Effective Menu Labeling Requirements

The FDA today released a final version of a November 2017 guidance document that promises a flexible approach to enforcement of agency regulations prescribing calorie declarations at restaurants and similar retail food establishments.  The release of the final guidance coincides with the effective date of the regulations.  Covered establishments are now expected to comply with the rule, following multiple extensions including one mandated by Congress conditioning enforcement on the agency’s publication of guidance.

As we previously discussed here and here, the rule requires covered food establishments to include three separate disclosures on all menus and menu boards: (1) calorie information for standard menu items and other specified items, (2) the statement that “2,000 calories a day is used for general nutrition advice, but calorie needs vary,” or a substitute statement for children’s menus and menu boards, and (3) a statement that written nutrition information is available upon request.  Establishments are only covered if they are part of a chain with 20 or more locations doing business under the same name and offering substantially the same menu items.

FDA Commissioner Scott Gottlieb explained in a statement last week that the guidance was intended to “make it easy for manufacturers and restaurants to provide this information in cost effective ways already found in many chains” and in a manner that “won’t require costly changes to existing infrastructure.”  Notable takeaways from the guidance include:

  • FDA intends to exercise enforcement discretion regarding the “calories from fat” declaration requirement in recognition of “current science support[ing] the view that the type of fat is more relevant with respect to the risk of chronic disease than the overall caloric fat intake.”
  • Covered establishments have some flexibility in determining how best to display required calorie information.  For example, an establishment with a self-service buffet could display calories next to each item, on the sneeze guard over an item, or on a single sign near the buffet.  The guidance offers images of displays that FDA considers compliant.  Similarly, the guidance explains that an establishment need not create menu boards in addition to paper menus or online menus to meet the requirements, but could add the information to paper menus or use an electronic kiosk to disclose calorie information in lieu of having a menu board.
  • FDA plans to take a “flexible and not prescriptive” approach to evaluating whether marketing materials constitute a “menu” or “menu board” that would be required to bear calorie information.  If the primary purpose of a sign is to entice customers into purchasing a particular item or items, then it would not generally require a calorie declaration.  Provided examples of materials that would not require calorie declarations include coupons, posters in store windows, and flyers.
  • Establishments are only counted towards the threshold number of 20 if they meet each of the following criteria: (1) they do business under the same name; (2) they sell substantially the same menu items; and (3) they sell restaurant-type foods (e., food that is usually eaten on the premises, while walking away, or soon after arriving at another location).  For example, if a store had 30 locations operating under the same name but only ten locations sold substantially the same menu items, then the establishments would not be covered under the rule.

The guidance also explains that FDA plans to “work cooperatively with covered establishments to come into compliance with the menu labeling requirements” and “continue with education and outreach, especially in the first year.”  Nonetheless, covered establishments should take notice and evaluate whether current labeling practices comply with now effective menu labeling requirements.

FDA Commissioner Continues To Roll Out Digital Health Initiatives

FDA Commissioner Scott Gottlieb trumpeted the agency’s “modern and flexible” approach to digital health regulation when speaking at Health Datapalooza last week.  As we have written about here, FDA has announced multiple initiatives over the last several months designed to clarify the regulatory considerations around new and emerging digital health technologies.  Last week’s speech continued this march, including the following highlights:

Digital Health Innovation Action Plan

Commissioner Gottlieb announced a new policy that streamlines the path for digital health products that contain several functions, some of which are subject to FDA medical device regulation, and some of which are not.  The new guidance, available here, attempts to clarify where FDA will and will not be reviewing certain software functions.  As expected, the focus of the agency’s review will be on the safety and effectiveness of higher-risk medical device functions that diagnose or treat patients.

Pre Cert 1.0 Coming by End of 2018

Last September, FDA announced its “Pre-Cert” pilot program, which focuses on the company’s program of design, testing, validation, operation, and maintenance rather than the features of a specific product to determine whether a company can be “pre-certified.”

Last week, Commissioner Gottlieb announced an update – the release of a Working Model of the program.  It is designed to be a first of several iterations, each informed by input from developers, patients, providers, and the public.  Commissioner Gottlieb said that FDA is committed to launching “Pre Cert 1.0” by the end of 2018, with further refinements in 2019.

Artificial Intelligence (AI) Regulatory Framework and Digital Health Incubator

Commissioner Gottlieb described AI as “one of the most promising digital health tools” and advocated employing the Pre-Cert approach to allow companies to make minor changes to their devices without having to make new submissions each time.  Given this potential, Gottlieb announced that FDA is “actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies.”  He stressed that the regulatory structure must be sufficiently flexible to keep pace with the field.

Consistent with the use of AI and machine learning to inform healthcare diagnoses and decisions, Commissioner Gottlieb announced the creation of an internal data science incubator called the Information Exchange and Data Transformation (INFORMED).  The initial focus of the incubator will be, among other things, “the conduct of regulatory science research in areas related to health technology and advanced analytics related to cancer.”  The project will also involve collaborations with Project Data Sphere, the National Cancer Institute, and Harvard University.

Drug Development and Safety Reporting Announcements

Commissioner Gottlieb announced two initiatives relating to drug development and safety.

  • First, in light of the multiple use cases for digital health and prescription drugs, new guidance will be released to address the role of digital health in drug development.  Specifics on timing were not mentioned.
  • Second, a new Premarket Digital Safety Program is underway to enable a unified data standard for meeting electronic reporting requirements under the expedited safety reporting regulations of an Investigational New Drug Application.  The new digital submission process is intended to eventually replace the paper-based system which Commissioner Gottlieb characterized as a “fragmented analog workflow.”

We will continue to follow FDA’s evolution in the regulation of digital health and keep you updated here.

Unanimous Recommendation for Cannabis-Based Epilepsy Drug; Trump Administration Lifts Threat of Cannabis Enforcement in States With Legalization; Schumer To Introduce Bill Decriminalizing Marijuana

On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention.  The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals.  The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found in cannabis that is not considered psychoactive.  If approved, Epidiolex would have orphan drug status, meaning that it is marketed to treat rare diseases or conditions, in this instance rare forms of epilepsy.  FDA is not bound by the advisory committee recommendations, but often follows them.

With Epidiolex’s approval likely looming, one question is what the impact will be on the CBD dietary supplements currently on the market. FDA has made clear that it does not believe that CBD can be legally marketed as a dietary supplement because of GW Pharmaceuticals’ initiation of investigational new drug applications for its products prior to CBD being marketed as a supplement.  Further, FDA has issued numerous warning letters relative to CBD labeled as dietary supplements but that contain little or no actual CBD as well as those that feature express disease treatment claims.  Will the approval of Epidiolex impact those CBD products currently sold as supplements? Continue Reading

Advertising Marijuana Businesses: The Federal Criminal Law You Need to Know

As the gravitational pull toward marijuana legalization continues, new sources of revenue continue to emerge. Former Republican House Speaker John Boehner (and former opponent of legalization) recently announced that he joined the board of directors for a cannabis company, and sales of cannabis in California are expected to exceed $3.5 billion in 2018 and to surpass the $5 billion mark in 2019.  As a result, media outlets stand to gain substantial sums in advertising revenue for all the newly-licensed state legal businesses.  But before placing any advertisement, companies need to consider the rarely-used but newly-relevant provision of federal criminal law that addresses advertising.

Although seldom used in federal criminal prosecutions, a provision of the Controlled Substances Act prohibits placing advertisements for marijuana and other Schedule I substances. 21 U.S.C. § 843(c)(1).  Specifically, this provision makes it “unlawful for any person to place in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule I controlled substance.” 21 U.S.C. § 843(c)(1).  So does that mean no one can run advertisements?  No, but it means that advertisements need to be approached with caution.  Continue Reading