FDA Opens Tobacco Rulemaking Dockets, Approves First Cannabis-Derived Drug and Reacts to the Legalization of Hemp, and Announces Plans to Significantly Change Medical Device Program
JONATHAN A. HAVENS*
Last year was a particularly active one for the U.S. Food and Drug Administration (FDA or the Agency), with significant regulatory and policy developments across a number of the product types that the Agency regulates. Such developments included the:
- Opening of tobacco rulemaking dockets related to lowering nicotine in cigarettes, tobacco product flavors, and premium cigars;
- Approval of the first cannabis-derived drug and reaction to the legalization of hemp; and
- Announcement of plans to significantly change the Agency’s medical device 510(k) clearance program.
Beyond developments at FDA, the U.S. Department of Agriculture (USDA) last year published a final rule to establish the new national mandatory bioengineered (BE) food disclosure standard (the Standard), which requires food manufacturers, importers, and other entities that label foods for retail sale to disclose information about BE food and BE food ingredients.
FDA Issues Three Tobacco ANPRMs
On March 15, 2018, FDA Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels (Nicotine ANPRM). Gottlieb’s announcement came nearly eight months after the Agency unveiled its planned tobacco regulatory policy shift to place nicotine, and the issue of addiction, at the center of FDA’s tobacco regulatory efforts.
In addition to offering some of the details of the Nicotine ANPRM at that time, Gottlieb also indicated in the announcement that FDA would soon issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use, and cessation of tobacco products (Flavor ANPRM) (which the Agency issued on March 21, 2018), and a second to solicit additional comments and data related to the regulation of premium cigars (Premium Cigar ANPRM) (which FDA issued on March 26, 2018).
The Nicotine ANPRM provided a wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and sought comment from the public as well as additional research and data for public review for FDA to consider as it evaluates a nicotine product standard. More specifically, FDA asked for feedback on a number of questions, including:
- What potential maximum nicotine level would be appropriate for the protection of public health?
- Should a product standard be implemented all at once or gradually?
- What unintended consequences – such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more – might occur as a result?
- How should potential consumer surplus or utility loss from the removal of nicotine in cigarettes be considered, given the availability of other sources of nicotine such as electronic nicotine delivery systems (ENDS) (g., e-cigarettes and vapor products) and the continued availability of combusted tobacco products?
On the topic of ENDS, the Agency refers to such products in the Nicotine ANPRM as “potentially less hazardous” than other tobacco products (i.e., combusted tobacco products). This is a continuation of a theme introduced for the first time in FDA’s announcement in July 2017 that within the continuum of risk of tobacco products, nicotine is most harmful when delivered through smoke particles in combusted cigarettes.
With regard to the Flavor ANPRM, as some may know, there is already a flavored combusted cigarette ban in place, as established by in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). However, Congress specifically carved menthol out of that ban, and mentholated cigarettes continue to be available. In addition, the flavor ban does not apply to noncombustible products (i.e., ENDS products), and flavored vapor products are wildly popular. If FDA eventually moves to restrict menthol, it would not be the first time the Agency has tried to regulate the flavor. By way of background, in July 2013, FDA issued an ANPRM to obtain public input on menthol in cigarettes but the Agency never moved forward with regulatory action on the same, due in large part to a successful industry challenge to the menthol report issued by FDA’s Tobacco Products Scientific Advisory Committee (TPSAC). While the U.S. Court of Appeals for the D.C. Circuit eventually upheld the Agency’s right to rely on TPSAC’s menthol report, FDA did not pursue further regulatory action. Of course, the Flavor ANPRM addresses far more than just menthol, as it also solicits comments on flavored cigars, flavored ENDS products, and flavored smokeless tobacco products. Per the pre-rule abstract on OMB, Office of Information and Regulatory Affairs’ (OIRA) website, the “ANPRM will seek information on how [FDA] might regulate flavors in tobacco products to limit appeal to youth while taking into account the potential role that some flavors may play in helping some users transition away from combusted products.” This excerpt sums up nicely the current debate about flavored ENDS products: how does the Agency limit appeal to youth while preserving adult choice and helping adults transition away from combusted products, which FDA suggests could be more harmful than ENDS products?
On the topic of premium cigars, Commissioner Gottlieb indicated in a speech in July 2017 that FDA was considering whether and how the Agency would exempt such cigars from the Deeming Rule, and that FDA planned to ask for “new information related to the patterns of use and resulting public health impacts from so-called premium cigars.” While the Agency’s Deeming Rule covers all cigars, Gottlieb has said that FDA will “explore any new and different questions raised, and seriously consider any additional data submitted relevant to the appropriate regulatory status of premium cigars.” To that end, the Agency asked for this and other feedback in its Premium Cigar ANPRM.
To be sure, FDA is still a long way off from promulgating nicotine, flavor, and/or premium cigar regulations. Between now and issuing final rules, the Agency would have to, among other things: (1) consider public comments received on the ANPRMs; (2) issue proposed regulations; (3) consider public comments received on the proposed rules; and (4) issue final regulations. Moreover, the dates by which industry would need to comply with final regulations, if any, would probably not be immediate, as effective and compliance dates would likely be staggered. And of course the Agency could give small-scale tobacco product manufacturers even more time to comply with final rules, as is FDA’s custom. With that said, it is possible that the Agency will merely publish the above-referenced ANPRMs and then take no further action. As discussed above, there is some precedent for this in the tobacco regulatory space. On the other hand, Commissioner Gottlieb has addressed repeatedly the importance of these dockets, including in his December 2017 blog post on FDA’s major policy goals for 2018 and in a January 2018 speech to Agency staff regarding the same.
Commissioner Gottlieb also discussed in the March 2018 announcement that the Agency was continuing to re-evaluate and modernize its approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches, and lozenges that help smokers quit. Gottlieb, together with Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research (CDER), and Mitch Zeller, J.D., Director of FDA’s Center for Tobacco Products (CTP), issued a blog post on this topic in November 2017.
Finally, Gottlieb also addressed in the announcement that the Agency planned to take new steps to ensure that its policies and processes for the regulation of tobacco products are efficient and predictable, and consistent with the mandate Congress gave FDA under the Tobacco Control Act. More specifically, he indicated that the Agency planned to issue a series of foundational rules and guidance documents on regulatory process, including on the demonstration of substantial equivalence (SE) and the submission of applications for new tobacco products, and release a framework for how FDA will address provisional SEs.
The Agency Approves First Cannabis-Derived Drug, DEA Schedules the Same, and FDA Reacts to Hemp Legalization
On June 25, 2018, FDA approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
Epidiolex represents the first FDA approval of a drug that contains a purified drug substance derived from cannabis; this is also the first time the Agency has approved a drug for the treatment of patients with Dravet syndrome. CBD is a chemical component of the Cannabis sativa L. plant, sometimes referred to as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC), another cannabinoid of the cannabis plant.
Prior to approving Epidiolex, FDA had only approved drug products containing synthetic THC, Marinol and Syndros, as well as Cesamet, which contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.
Under the Controlled Substances Act, marijuana-derived CBD is a Schedule I substance (i.e., no currently accepted medical use and a high potential for abuse). Once FDA approved Epidiolex, the U.S. Drug Enforcement Administration (DEA or the Administration) was required to make a scheduling determination regarding the same, which it did after it received from the Agency (through the U.S. Department of Health and Human Services (HHS)) a medical and scientific analysis.
On September 28, 2018, DEA published in the Federal Register an order scheduling FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols (THC) in Schedule V. By way of background, Schedule V products are those with a lower potential for abuse than Schedule IV (i.e., a drug product that has a low potential for abuse and low risk of dependence) and consisting of preparations containing limited quantities of certain narcotics. Currently, the only FDA-approved drug that meets these criteria is Epidiolex. As a result of DEA’s scheduling order, all persons in the distribution chain who handle Epidiolex in the U.S. (importers, manufacturers, distributors, and practitioners) are required to comply with the requirements of the CSA and DEA’s regulations relating to Schedule V controlled substances (e.g., DEA’s valid prescription requirements).
In reflecting on FDA’s approval of Epidiolex, Commissioner Gottlieb noted that the Agency would “continue to support rigorous scientific research on the potential medical uses of marijuana-derived products,” but also indicated that FDA was “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.” Not only is the Agency prepared to take such enforcement action, but it has a history of already doing so. While the Commissioner did not say as much directly in FDA’s press release, one had to wonder in response to reading the same whether the Agency would continue to take a largely hands-off approach to “over-the-counter” CBD products (i.e., those that are sold at convenience stores, gas stations, and other retail outlets), as long as marketers do not make serious, unproven medical claims regarding the same.
Months later, on December 20, 2018, President Trump signed into law the 2018 Farm Bill. Among other things, the 2018 Farm Bill removes hemp from the definition of “marihuana” (marijuana) in the Controlled Substances Act (CSA), thus taking it out of Schedule I.
By way of background, the Agricultural Act of 2014 (2014 Farm Bill) authorized states to establish agricultural pilot programs or other agricultural or academic research programs to study the growth, cultivation, or marketing of industrial hemp.” The 2014 Farm Bill defined industrial hemp as “the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.” Despite the 2014 Farm Bill’s authorization to states to establish hemp pilot programs, the legislation did not specifically address the Schedule I status of hemp. In contrast, the 2018 Farm Bill amends the CSA to state that the term marijuana does not include hemp. In addition, the 2018 law also amends the definition of hemp in the Agricultural Marketing Act of 1946, with the result being an expansion of the definition referenced in the 2014 Farm Bill. It is now clear that hemp is no longer federally illegal under the CSA, but it is also clear that the phrase “any part of the plant” includes “the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers.” This definition expansion is significant, given its inclusion of hemp-derived cannabinoids (e.g., CBD), and given the already explosive growth of the CBD-infused products market, a trend which will no doubt continue now that hemp is legal.
Now that the 2018 Farm Bill is law, many are asking: What’s next? Unfortunately, the complicated web of federal and state laws that govern hemp cultivation, processing, manufacturing, distribution, and sales did not go away overnight, and are here to stay for some time.
The bill directs the U.S. Department of Agriculture (USDA) to develop federal hemp regulations “as expeditiously as practicable.” Without a specific timetable attached to this responsibility, promulgation of regulations could take a year or more. While the law will allow states to be the primary regulators of hemp, this will only occur if a state can demonstrate to USDA that it can properly monitor cultivation and production. If states are unable or unwilling to create their own regulatory plans, USDA would maintain oversight. Until USDA issues its regulations, hemp cultivators and processors will continue to be subject to state pilot programs.
Eventually, states will submit to USDA their plans to regulate hemp. While there is not a deadline for states to do so, once a state submits a plan to USDA, the agency will have 60 days to approve or reject it.
One of the biggest misconceptions coming out of the enactment of the 2018 Farm Bill is: Now that hemp is legal, people can do whatever they want with it and its derivatives. This is not correct. While the 2018 Farm Bill is significant, and while it will open up national and international hemp markets, there continue to be restrictions on what can be done with hemp and hemp derivatives (e.g., hemp-derived CBD). This is especially true when it comes to the addition of CBD or THC to a product regulated by the FDA.
In response to the 2018 Farm Bill being signed into law, FDA Commissioner Scott Gottlieb, M.D., was quick to remind the public about what the legislation did not change: the Agency’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) and section 351 of the Public Health Service Act. While this is not surprising to those that carefully read the text of the 2018 Farm Bill, which specifically preserves FDA’s authority, or to those that read the Agency’s response to the 2014 Farm Bill, it is a very important nuance.
FDA does not distinguish between hemp-derived CBD and marijuana-derived CBD, even though the latter is Schedule I and the former is not. Accordingly, FDA’s restrictions on adding CBD to products regulated by the Agency remain in place. The 2018 Farm Bill did nothing to change that. More specifically, it is unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the Act, it is illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.
While some might question FDA’s position, and think that hemp’s removal from Schedule I should necessitate a different approach by the Agency, FDA’s thinking is informed by CBD’s and THC’s roles as drug ingredients. The fact that hemp-derived CBD is no longer Schedule I is of no consequence. Just as GW Pharmaceuticals did when it submitted a new drug application (NDA) for Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, which FDA approved in June 2018, companies have a viable (albeit expensive and time consuming) pathway before FDA to seek approval to market with therapeutic claims a human or animal drug that is derived from cannabis.
Concurrently with the issuance of its response to the signing of the Farm Bill, FDA announced that it had completed its evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein, and hemp seed oil, and that the Agency had no questions regarding the sponsor’s conclusion that the use of such products as described in the notices is safe. As a result, these products can now be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims. In the same breath, FDA was quick to point out in its update on the GRAS notices that the review decisions do not affect the Agency’s position on the addition of CBD and THC to food. As stated in FDA and Marijuana: Questions and Answers, it is still a prohibited act under section 301(ll) of the FD&C Act to introduce into interstate commerce a food to which CBD or THC has been added.
So what are we to make of FDA’s approach to CBD or THC in foods and dietary supplements? Prior to the 2018 Farm Bill, the Agency took a largely hands-off approach to enforcement in this area, absent aggressive disease claims. It is hard to say how aggressively FDA will pursue hemp-infused products now that the 2018 Farm Bill is law. Oddly, FDA has a question in its “Marijuana: Questions and Answers” document regarding whether the Agency will take enforcement action regarding THC and CBD products that are marketed as dietary supplements or regarding foods to which THC and CBD has been added. In response, while FDA does not say “no,” the Agency invokes in its answer the concepts of “agency resources” and “the threat to public health,” suggesting a continuation of the largely hands-off approach, again, absent aggressive disease claims and/or a threat to public safety.
Lastly, in Commissioner Gottlieb’s reaction statement, he left open the possibility that FDA could pivot (e.g., issue a regulation allowing the use of CBD in a food or dietary supplement). However, and as expected, he indicated that the Agency would only consider doing so if it is able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.
While many have claimed that the DEA will no longer have a role to play in the hemp space, an open question is how aggressively, if at all, DEA will look into the source of products being held out as containing hemp-derived CBD (i.e., try to determine if they contain marijuana-derived CBD, instead). Although enforcement in the CBD space has been sporadic, now that hemp-derived CBD will be even more widely available, one has to wonder if the openness of the market and the increase in consumers will result in enhanced oversight and enforcement.
More broadly, it remains to be seen how DEA will react to the signing of the Farm Bill. Will the agency issue its own regulations, or at least a policy statement? DEA’s confusing approach to all CBD pre-2018 Farm Bill suggests that the tortured status of CBD products generally, hemp-derived or otherwise, could continue.
It cannot be denied that the 2018 Farm Bill becoming law is a significant development. At long last, the confusing legal and regulatory status of hemp will start to be clarified. As noted above, though, this clarity will not come overnight, as USDA could take at least a year to issue regulations. How long USDA will take to craft its regulations is but one open question. A few others are: How rigorous will USDA be when reviewing longstanding state hemp programs? Will processors and marketers be able to prove to DEA’s satisfaction that their products are hemp-derived rather than marijuana-derived? Will FDA look the other way when firms selling CBD-infused foods, dietary supplements, and cosmetic products take advantage of an exploding market but do not make aggressive disease claims? Will FDA issue a regulation allowing the use of hemp-derived CBD in foods and dietary supplements?
FDA Announces Plans to Change Medical Device Clearance Program
On November 26, 2018, FDA issued an extensive policy statement outlining the Agency’s plans to “modernize” the Agency’s medical device premarket notification (i.e., 510(k)) program.
In the announcement, Commissioner Gottlieb and Dr. Jeff Shuren, Director of FDA’s Center for Devices and Radiological Health (CDRH), explained the Agency’s rationale for why FDA would like to change the existing process to clear certain medical devices through the so-called 510(k) pathway. The current 510(k) process has been in existence since the mid-1970s. This 510(k) announcement was a follow-up from FDA’s April 2018 Medical Device Safety Action Plan (Safety Action Plan).
By way of background, the Medical Device Amendments to the FD&C Act were enacted in 1976. The Medical Device Amendments created a risk-based classification system for all medical devices and established the regulatory pathways for new medical devices (devices that were not on the market prior to May 28, 1976, or had been significantly modified) to get to market: Premarket Approval (PMA) and premarket notification (510(k)). In 1990, the Safe Medical Devices Act defined “substantial equivalence,” which is the standard for marketing a device through FDA’s 510(k) program. Substantial equivalence means that the new device is at least as safe and effective as the predicate (i.e., the legally marketed device to which the new device is being compared). A device is substantially equivalent if, in comparison to a predicate, it:
- has the same intended use as the predicate; and
- has the same technological characteristics as the predicate; or
- has the same intended use as the predicate; and
- has different technological characteristics and does not raise different questions of safety and effectiveness; and
- the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.
The 510(k) process is significantly less burdensome than the PMA process – most PMAs require clinical data whereas most 510(k)s do not – and this is one of the reasons the 510(k) process is popular among medical device firms, physician entrepreneurs, hospitals, and academic medical centers, with some estimating that approximately 80 percent of devices on the U.S. market have been developed and cleared pursuant to FDA’s 510(k) program.
There are several key take-aways from FDA’s statement that interested parties should monitor as the Agency moves to the next phase of this process:
- Public Disclosure of Use of Predicates More Than 10 Years Old: FDA believes that newer devices should be compared to the benefits and risks of more modern technology and it is considering making public on its website those 510(k)-cleared devices that demonstrated substantial equivalence to predicates that are more than 10 years old. FDA’s stated goal is to drive sponsors to continually offer patients devices with the latest improvements and advances. The Agency will be seeking public feedback on this aspect of the proposal.
- Potential Sunsetting of Older Predicates; Promotion of the Use of Modern Predicates: FDA is considering a sunset of certain older predicates and promotion of the use of more modern predicates. This may require the enactment of new legislation.
- Alternative “Safety and Performance Based” 510(k) Pathway/Abbreviated 510(k) Program By a Different Name?: FDA’s announcement suggests that in early 2019 it intends to finalize guidance establishing an alternative 510(k) pathway that allows manufacturers of certain well-understood device types to rely on “objective safety and performance criteria” to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products. The Agency believes this approach is the “future of the 510(k) program.” It is not known what “objective safety and performance criteria” will be used to demonstrate substantial equivalence, and how, if at all, this pathway will substantively differ from FDA’s abbreviated 510(k) pathway, which relies on the use of guidance documents, special controls, and recognized standards.
The President and CEO of the Advanced Medical Technology Association (AdvaMed) observed that the Agency’s “proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices.” AdvaMed noted that “in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little using those older predicates still makes sense.”
FDA’s potential sun setting of older predicates is the aspect of the proposal that could have the most significant impact on industry, physician entrepreneurs, hospitals, and academic medical centers. If, for example, parties are no longer able to rely on certain predicates, they would no longer be able to market their devices unless they found a more recent predicate, or unless they obtained another clearance or approval. This could produce gaps in the marketplace.
As the old adage goes, “the devil is in the details.” While the announcement was long, many questions and details were not provided in the statement.
While FDA may need legislation enacted to achieve some of its goals, it is not yet clear whether Congress will be interested in moving forward with any legislation or the priorities it may consider.
USDA Publishes National Mandatory Bioengineered (BE) Food Disclosure Standard Final Rule
On December 21, 2018, USDA published in the Federal Register the new national mandatory bioengineered (BE) food disclosure standard (the Standard). As previewed above, the Standard requires food manufacturers, importers, and other entities that label foods for retail sale to disclose information about BE food and BE food ingredients. The purpose of the final rule is to set forth a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods.
By way of background, the National BE Food Disclosure Law, passed by Congress in July 2016, directed USDA to establish a national mandatory standard for disclosing foods that are or may be bioengineered. The BE Standard requires food manufacturers, importers, and certain retailers to ensure BE foods are appropriately disclosed. The Standard defines BE foods as those that contain detectable genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques for which the modification could not otherwise be obtained through conventional breeding or be found in nature.
USDA’s Agricultural Marketing Service (AMS) developed a List of Bioengineered Foods to identify the crops or foods that are available in BE form throughout the world and for which regulated entities must maintain records. The records will inform regulated entities on whether the food must have a BE disclosure to be communicated to consumers. Regulated entities have several disclosure options: text; symbol; electronic or digital link; and/or text message. Additional options such as a phone number or web address are available to small food manufacturers or for small/very small packages.
The BE Standard applies to:
- Foods that are subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (g., raw produce, seafood, dietary supplements, and most prepared foods, such as breads, cereals, non-meat canned and frozen foods, snacks, desserts, and drinks).
- Chewing gum.
- Some meat, poultry, and egg products regulated by USDA (if an FDA-regulated ingredient is the most predominant).
The Standard does not apply to:
- Pet food.
- Animal feed.
- Distilled spirits, wines, or malt beverages as defined by the Federal Alcohol Administration Act (FAA Act).
Exempt from the BE Standard is/are:
- Food served in restaurants or similar retail food establishments.
- Very small food manufacturers (e., annual receipts of less than $2.5 million).
- Animals fed with bioengineered feed (e., food derived from an animal will not be considered a BE food solely because the animal consumed feed produced from, containing, or consisting of a BE substance).
- Food certified under the National Organic Program.
Significantly, there is a threshold for the inadvertent or technically unavoidable presence of BE substances of up to five percent for each ingredient.
In dealing with incidental additives in the Standard, USDA borrowed a concept from the FD&C Act. Incidental additives that are present in food at an insignificant level and do not have any technical or functional effect in the food are exempt from certain labeling requirements under the FD&C Act. Similarly, under the BE Standard, incidental additives are exempted from BE disclosure if they are not required to be labeled per the FD&C Act and FDA’s implementing regulation. Under the Standard, incidental additives include:
- Substances migrating to food from equipment or packaging or otherwise affecting food that are not food additives, as defined, or if they are food additives as defined, they are used in conformity with implementing regulations.
- Substances included in 21 C.F.R. § 101.100(a)(3)(i), (ii), and (iii) (lists of incidental additives that are not required to be labeled under FDA regulations and by extension are not required to be disclosed as BE foods).
- With regard to yeasts, enzymes, or any other microorganisms, if they qualify as incidental additives that are not required to be labeled as ingredients on a food label, then they do not require disclosure as BE foods.
- However, bioengineered yeasts, enzymes, and other organisms that do not qualify as incidental additives that are not required to be labeled as ingredients may require disclosure as BE foods unless they meet the requirements of another provision (g., if modified genetic material is not detectable).
Foods with undetectable modified genetic material are not BE foods (e.g., refined foods). Regulated entities can demonstrate that modified genetic material is not detectable by:
- Maintaining records verifying that a food is sourced from a non-bioengineered crop or source;
- Showing that a food has been subjected to a refinement process validated to remove modified genetic material; and/or
- Maintaining records of analytical testing results demonstrating the absence of modified genetic material.
In the BE Standard rule, USDA provides a list of BE foods to provide regulated entities with a tool to determine whether a food must bear a BE disclosure. These foods comprise most of the BE crops or foods grown in the world and, therefore, most of the BE food and food ingredients. They are:
- Apple (Arctic™ varieties);
- Eggplant (BARI Bt Begun varieties);
- Papaya (ringspot virus-resistant varieties);
- Pineapple (pink flesh);
- Salmon (AquAdvantage®);
- Squash (summer); and
If a regulated entity is using a food, including an ingredient produced from such food, not on the List of BE Foods, and the regulated entity has actual knowledge that the crop or ingredient is, in fact, bioengineered, the entity is still responsible for labeling the food in compliance with the BE Standard. However, if a regulated entity uses a food, including an ingredient produced from such food, on the List of BE Foods and its records demonstrate that the food is not bioengineered (e.g., modified genetic material is not detectable) or is exempt from disclosure, the food is not required to bear a BE disclosure.
There are multiple disclosure options to comply with the BE Standard. Under option one, regulated entities may utilize text to disclose the presence of BE food or BE food ingredients for foods in the List of BE Foods. The text “bioengineered food” is appropriate for:
- A food, including a food ingredient produced from that food, that is a raw agricultural commodity and for which records demonstrate that the food or food ingredient is BE or does not indicate whether the food or food ingredient is BE.
- Multi-ingredient food products in which all ingredients are on the List of BE Foods and are BE or records do not indicate whether the ingredients are BE.
The text “contains a bioengineered food ingredient” is appropriate for a multi-ingredient food that contains ingredients that are and are not on the List of BE Foods and records demonstrate that at least one of the ingredients is BE, or do not indicate whether any of the ingredients produced from one of the foods on the List of BE Foods are BE.
For BE food that is distributed solely in a U.S. territory, required disclosure statements are allowed in the predominant language of that territory. Disclosure text must “be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions.”
Under option two, regulated entities may use a symbol to designate BE food or food that contains a BE food ingredient. The symbols allowed are:
Option three permits regulated entities to use an electronic or digital link (e.g., QR Code, digital watermark technology) to disclose BE food. Such a link must be accompanied by statement “Scan here for more food information” or equivalent language that reflects technological changes. Because current technologies may or may not include an embedded Uniform Resource Locator (URL), USDA will allow for other alternative statements that can appear above or below an electronic or digital link to direct consumers to the link to the BE food disclosure (e.g., “Scan anywhere on package for more food information,” or “Scan icon for more food information.”).
Finally, under option four, regulated entities may choose to send consumers a text message. Entities that choose this option are required to include a statement on the package that instructs consumers on how to receive a text message. A one-time automated response would immediately provide the disclosure using text.
The BE rule became effective on January 19, 2019, but will not be implemented until January 1, 2020. The extended implementation date for small food manufacturers is January 1, 2021. The voluntary compliance period ends on December 31, 2021, and the mandatory compliance date is January 1, 2022.
On March 5, 2019, FDA Commissioner Gottlieb announced that he was resigning, and that he would be leaving the Agency within a month’s time. While the Agency’s work will of course carry on, under the leadership of Acting Commissioner Dr. Norman “Ned” Sharpless, previously the Director of the National Cancer Institute (NCI), one has to wonder how the Agency’s priorities could shift in the wake of Gottlieb’s departure. For example, with regard to the future of CBD in food and beverage products, Sharpless or Gottlieb’s permanent replacement could “have strong feelings on the issue or may decide to ignore it,” altogether. While some have predicted that FDA will stay the course on tobacco regulation, others are hopeful that Gottlieb’s exit will ease the burden on regulated industry. Predictions aside, and regardless of whether or not one agreed with his policies, it is difficult to imagine a replacement who will be as engaged and dynamic as Commissioner Gottlieb has been.
* Jonathan A. Havens is a Partner at Saul Ewing Arnstein & Lehr LLP, where he is chair of the firm’s Food and Beverage Practice, co-chair of the firm’s Cannabis Law Practice, and a member of the firm’s Life Sciences Practice. He counsels clients on regulatory, compliance, enforcement, and transactional matters related to products regulated by, among others, the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), the U.S. Drug Enforcement Administration (DEA), the U.S. Consumer Product Safety Commission (CPSC), and myriad state agencies.
 FDA, “Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels,” Mar. 15, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM601039.htm?utm_campaign=Statement_ANPRM%20to%20reduce%20nicotine%20in%20cigs&utm_medium=email&utm_source=Eloqua
 FDA, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes; Advance Notice of Proposed Rulemaking, 83 Fed. Reg. 11,818 (Mar. 16, 2018).
 FDA, “FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death,” July 28, 2017, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.
 FDA, Regulation of Flavors in Tobacco Products; Advance Notice of Proposed Rulemaking, 83 Fed. Reg. 12,294 (Mar. 21, 2018) .
 FDA, Regulation of Premium Cigars; Advance Notice of Proposed Rulemaking, 83 Fed. Reg. 12,901 (Mar. 26, 2018) .
 FDA, Menthol in Cigarettes, Tobacco Products; Request for Comments, 78 Fed. Reg. 44,484 (July 24, 2013) .
 OMB, OIRA, “Kid-Appealing Flavors in Tobacco Products; Request for Information,” Fall 2017,
 Speech by FDA Commissioner Gottlieb, “Protecting American Families: Comprehensive Approach to Nicotine and Tobacco,” July 28, 2017, available at https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm.
 Blog Post by FDA Commissioner Gottlieb, “Looking ahead: Some of FDA’s major policy goals for 2018,” Dec.
14, 2017, https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm611999.htm.
 Speech by FDA Commissioner Gottlieb, “Remarks by Dr. Gottlieb on FDA Priorities,” Jan. 11, 2018, available at https://www.fda.gov/NewsEvents/Speeches/ucm592240.htm.
 Blog Post by FDA Commissioner Gottlieb, CDER Director Woodcock, and CTP Director Zeller, “Advancing Medicinal Nicotine Replacement Therapies as New Drugs – A new step in FDA’s comprehensive approach to tobacco and nicotine,” Nov. 29, 2017, https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm612005.htm.
 FDA, “FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy,” June 25, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements /ucm611046.htm?utm_campaign=06252018_PR_FDA%20approves%20marijuana-derived%20drug%20to%20treat%20two%20forms%20of%20epilepsy&utm_medium=email&utm_source=Eloqua.
 DEA, Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements; Final Order, 83 Fed. Reg. 48,950 (Sept. 28, 2018).
 Public Law No. 113-79.
 Public Law. No. 115-334.
 FDA, “Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds,” Dec. 20, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm?utm_campaign=122018_Statement_FDA%20statement%20on%20regulation%20of%20cannabis-containing%20products&utm_medium=email&utm_source=Eloqua.
 FDA Constituent Update, “FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use In Human Food,” Dec. 20, 2018, https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm628910.htm.
 FDA, “FDA and Marijuana: Questions and Answers,”
https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm#legal (last visited Mar. 18, 2018).
 FDA, “Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices,” Nov. 26, 2018, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm.
 FDA, “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health,” available at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm604500.htm (last visited Mar. 18, 2019).
 UL, U.S. Medical Device Clearance: Navigating the FDA 510(k) Premarket Approval Process for Medical Devices, available at https://library.ul.com/wpcontent/uploads/sites/40/2015/02/UL_WP_Final_U.S.-Medical-Device-Clearance-Navigating-the-FDA-Premarket-Approval-Process-for-Medical-Devices_v5_HR.pdf (last visited Mar. 18, 2019).
 AdvaMed, “AdvaMed Statement on FDA 510(k) Modernization Plan,” Nov. 26, 2018,
 USDA, National Bioengineered Food Disclosure Standard; Final Rule, 83 Fed. Reg. 65,814 (Dec. 21, 2018).
 USDA/AMS, List of Bioengineered Foods, https://www.ams.usda.gov/rulesregulations/be/bioengineered-foods-list (last visited April 11, 2019).
 Angelica LaVito, “FDA chief Scott Gottlieb’s resignation leaves ‘billion-dollar question’ for CBD industry,” CNBC.com, Mar. 7, 2019, https://www.cnbc.com/2019/03/07/fda-chief-departure-leaves-billion-dollar-question-for-cbd-industry.html.
 See Sarah Toy, “Wall Street sees brighter future for tobacco companies now that Gottlieb is stepping down,” MarketWatch, Mar. 6, 2019, https://www.marketwatch.com/story/wall-street-sees-brighter-future-for-tobacco-companies-now-that-gottlieb-is-stepping-down-2019-03-06.
Top Food and Drug Cases, 2018
& Cases to Watch, 2019