FDA Commissioner Nominee Gottlieb’s Written Responses Signal Support for Food Safety and Science-Based Approach to Consumer Communications

Dr. Scott Gottlieb, recently submitted written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee as a follow up to his hearing on April 5.  As a follow up to our April 13 post, below are selected Q&A exchanges based on questions submitted by Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA).

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Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as Commissioner of the Food and Drug Administration.  As part of the hearing, Gottlieb was questioned on an array of topics from his prior service at FDA to his alleged financial interests in pharmaceutical companies.  He was also asked to comment on a number of issues relating to food safety, labeling, and the overall approach that he envisions for FDA as a public health agency.  Highlights of his responses on those issues are below.

On FSMA Implementation: Gottlieb considers FSMA to be necessary to ensure the safety of the nation’s food supply and stated that he plans to protect and promote public health as Congress intended when writing the law. As regular readers of our blog know, food safety and the federal GMO labeling law have been rare examples of bipartisan cooperation in recent years.

On Understanding the Financial Demands on Industry:  Gottlieb was asked whether he would ensure that proper guidance is available for implementation of the recent revisions to regulations governing nutrition facts labeling and whether he would consider postponing the deadline for new labels.  He was not specific about the possibility of extending the compliance date.  However, he did note that:

I’m philosophically in favor of trying to make sure we do these things efficiently not only because it imposes undue costs on manufacturers if they’re constantly updating their [nutrition facts] labels but we also have to keep in mind it causes confusion for consumers if the labels are constantly changing, so you want to consolidate the label changes . . . as a matter of public health so the information is conveyed accurately and efficiently to consumers.  So this is something that I do care about and I look forward to working on it if I’m confirmed.

Gottlieb’s remarks demonstrate a welcome acknowledgment of the extensive compliance costs associated with revisions to nutrition labeling requirements, and the capacity to lessen the regulatory burden on industry by streamlining changes and providing guidance to industry on how to comply.

On Commitment to Science-Based Policies:  Gottlieb assured senators he would take a science-based approach and would study issues raised related to genetically modified fish and guidance on seafood consumption for pregnant and nursing women. The FDA most recently issued advice in January 2017 that ranked fish in terms of its safety of consumption for expectant mothers with special attention to the amount of mercury.  The guidance, however, did not address the effects of other contaminants, as well as the nutritional benefits of fish, which has created confusion among consumers because the agency’s initial guidance in 2014 was different.

On Antibiotic Resistance: Gottlieb referred to his time as a physician and the loss of patients to antibiotic-resistant infections to express his understanding of the ongoing problem. He recognized that congressional statutes have been the driving force behind the FDA taking steps to address the issue, both on the development side and with the use of anti-infectives in animal feed.  The use of antibiotics in animals can allow resistant bacteria to contaminate the food supply, which makes the study of anti-infectives in animal feed all the more crucial in deterring the rise of antibiotic resistance.

The Senate has a two-week recess, which means they likely will not vote on this nomination until the week of April 24. Gottlieb’s nomination is expected to be confirmed.

Oregon Attorney General Announces $545,000 Settlement with Retailer

The Oregon AG recently announced a $545,000 settlement with the Vitamin Shoppe over allegations that the store violated Oregon state law by selling dietary supplements containing ingredients that FDA has deemed unsafe or unlawful. The new settlement agreement places significant burdens on the Vitamin Shoppe to monitor developments on ingredient status. The burdens are the same regardless of whether the Vitamin Shoppe sells a product under one of its own brands – or if it sells a product that was manufactured, labeled, and sold to it by a third party vendor.

Under the terms of the agreement, if the Vitamin Shoppe “receives or learns of” a “written notice” from FDA that an ingredient may be unsafe or unlawful, it must “take immediate action to suspend the sale of such products or products known to contain the ingredients.” If the Vitamin Shoppe becomes aware of any other “public announcement, warning, alert, publication, notice, or report” suggesting that the U.S. government, Australia, Canada, Britain, or the EU might consider a dietary ingredient unsafe or unlawful under the FDCA, then the Vitamin Shoppe must conduct a “reasonable due diligence review,” which may result in a decision not to sell any products containing the ingredient.

This settlement is notable for at least two reasons:

  1. It identifies FDA warning letters sent to the Vitamin Shoppe or anyone else as “written notice” that FDA has deemed an ingredient unsafe or unlawful.  Warning letters, however, state only allegations and are not considered “guidance” under FDA’s rule on “good guidance practices.”  Well after a warning letter is issued, the lawfulness of a particular dietary ingredient can be the subject of much ongoing debate, and even the FDA’s official guidance document on ingredient status remains in flux after years of debate.
  2. The settlement represents an aggressive stance by Oregon on a retailer’s liability for product formulation and labeling by third parties.  As we’ve discussed before, there isn’t a whole lot of precedent for regulators going after the retailer, rather than the product seller.

The Oregon Attorney General is currently in litigation against another retailer over similar allegations related to the legal status and safety of a dietary ingredient.

Kelley Drye Ad Law publishes News & Views: Dietary Supplement Advertising, which covers developments ranging from FTC and FDA regulation, class actions, Customs developments, and Prop 65. Subscribe to future issues by filling out your information and checking the Dietary Supplements Practice Group box here.

State AGs and the New Administration

As we discussed in recent interviews with Nutritional Outlook and Natural Products Insider, FTC enforcement against supplement companies is likely to evolve into something  much more reasonable under the new administration.  State attorney general activity, however, is likely to become more aggressive – or at least more widespread.  State regulators may perceive a need to fill in gaps or may see an opportunity for revenue that will be missed by federal regulators.

States to keep an eye on in coming months include Indiana, Oregon, Missouri, Hawaii, Tennessee, Maine, and as discussed more below, Iowa.  These states have either become more active in supplement cases recently or have expressed an interest in increased regulation of the industry.  New York and California have been, and remain, active in enforcement against dietary supplement companies.

As part of our Ad Law group’s new webinar series, we’ll be hosting a discussion focused on state regulation and enforcement on April 26, 2017.  Also, on May 3, 2017, Kelley Drye will host an event focused on the first 100 days of the Trump Administration.  A panel session will include state attorneys general who will provide regulatory updates and insights on enforcement.

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This post comes from Dietary Supplement Advertising, our newsletter produced to help marketers of dietary supplements stay out in front of regulatory challenges. Find the latest issue here. Access our Publication Sign Up page and select Dietary Supplements to subscribe.

Dietary Supplement Advertising

Did you know Kelley Drye’s Advertising Law practice produces a newsletter, Dietary Supplement Advertising, to help marketers of dietary supplements stay out in front of regulatory challenges. Click here to access our Publication Sign Up and select Dietary Supplements to subscribe. Find contents from the latest issue below:

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STATE REGULATION
State AGs and the New Administration
By John Villafranco and Katie Bond

As we discussed in recent interviews with Nutritional Outlook and Natural Products Insider, FTC enforcement against supplement companies is likely to evolve into something much more reasonable under the new administration.  State attorney general activity, however, is likely to become more aggressive – or at least more widespread.  State regulators may perceive a need to fill in gaps or may see an opportunity for revenue that will be missed by federal regulators.

States to keep an eye on in coming months include Indiana, Oregon, Missouri, Hawaii, Tennessee, Maine, and as discussed more below, Iowa.  These states have either become more active in supplement cases recently or have expressed an interest in increased regulation of the industry.  New York and California have been, and remain, active in enforcement against dietary supplement companies.

As part of our Ad Law group’s new webinar series, we’ll be hosting a discussion focused on state regulation and enforcement on April 26, 2017.  Also, on May 3, 2017, Kelley Drye will host an event focused on the first 100 days of the Trump Administration.  A panel session will include state attorneys general who will provide regulatory updates and insights on enforcement.

Iowa: The New New York or California?
By Katie Bond

Regulators in New York and California have been a perennial concern for dietary supplement makers for years.  Iowa now appears to be angling to join them.  The following summarizes activities of the Iowa AG’s office over the last two years.

  • The Iowa AG’s office was involved in the 2015 investigations into numerous store-brand botanical products.  Based on testing that was widely known to be faulty, regulators led by the New York AG, alleged that products lacked the botanical ingredients that they were labeled as containing.
  • Also in 2015, the Iowa AG joined 13 other state AGs in sending a letter to Congressional leaders urging them “to launch a comprehensive congressional inquiry into the herbal supplements industry, and to weigh a more robust oversight role for the Food and Drug Administration.”
  • In September 2016, the Iowa AG’s office announced a $30,000 settlement with an Australian company over bladder control claims for its dietary supplements.
  • The same month, the Iowa AG’s office announced a $100,000 settlement with Walmart over the following statement on its store brand supplements: “Verified by an independent, certified laboratory.”  The AG’s office contended that the statement exaggerated the level of testing backing the products.  Walmart vehemently disputed the allegations and noted that the AG’s office had received no complaints about the statement.  Walmart agreed to remove the statement in order to settle the case.
  • Also in September 2016, the Iowa AG’s office reached a settlement with a dietary supplement company that allegedly violated a 2014 order entered in Iowa.  The earlier order banned the company from telemarketing in the state.  According to the AG’s office, the company teamed up with a third party company to attempt to complete telemarketing sales in Iowa despite the order.

A consumer newsletter published by the Iowa AG’s office last year focused on dietary supplements and suggested a skeptical view of the industry overall.  One passage stated as follows:
Although supplement marketers often promote their products a[s] vital to good health, supplements shouldn’t replace a healthy, balanced diet. You may not need supplements if you maintain a good and varied diet, and too much of some nutrients (such as through vitamins) can cause problems. On the other hand, there are people who will benefit from some types of supplements — such as pregnant women who take folic acid.

But, as largely unregulated products, supplements may contain ingredients not listed on the product label; contain ingredients at higher or lower amounts than listed (or not even contain a listed ingredient); could be manufactured inconsistently; sellers may make false, misleading or unsupported “miracle cure” health claims; and some products may lead to serious health effects or even death. Unlike with drugs, supplement manufacturers are not allowed to promote their products to treat, diagnose, prevent, or cure diseases.

CLASS ACTIONS

Class Actions over St. John’s Wort Still Flowing from Consumer Labs Testing
By Katie Bond

Two retailers recently faced class action complaints over the ingredient content of store-brand St. John’s Wort products.  Plaintiffs allege that products provide less of the active component, hypericin, than labels indicate.  A similar class action naming several manufacturers is currently being litigated in Illinois.

These class actions followed an announcement by Consumer Labs last year that it had commissioned testing of ten St. John’s Wort products and found that some contained less than the declared amounts of standardized actives.  Consumer Labs offered access to its testing reports to those who agreed to pay a one or two-year membership fee (advertised costs: $39 for one year, $64 for two).  Consumer Labs noted that “[a]ll supplements were further tested for potential contamination with the heavy metals arsenic, cadmium, and lead.”

Trends in Consumer Class Actions

The following are areas where dietary supplement makers continue to face class actions:

  • Slack fill;
  • Purported “protein spiking”;
  • Joint claims based on glucosamine and chondroitin;
  • Weight loss claims; and
  • “Made in the USA” claims.

Kelley Drye partners Jeff Jacobson and August Horvath recently hosted a webinar, “Litigation is Inevitable.”  They provided an update on class action trends across a range of industries and provided guidance and strategies on how to knock out cases.  A recording of the webinar is available here. 

Partner Kristi Wolff co-authored the Nutritional Outlook article “Suing over Empty Space: Why Lawsuits over Slack Fill in Packaging Are Growing.”

FTC REGULATION

FTC Business Guide on CRFA
By John Villafranco and Katie Bond

The FTC recently issued a business guide on the Consumer Review Fairness Act (“CRFA”).  The CRFA, which was enacted in late 2016, prohibits businesses from including in form contracts any provisions that would restrict the ability of consumers to provide reviews about the goods or services they purchased.

The new business guide provides a brief overview of the law without adding much else.  The guide notes that an example of a CRFA violation would be a company that provides a product or service online and includes a provision “in its terms and conditions that prohibits or punishes negative reviews by customers.”

The new business guide also describes exceptions in CRFA that allow reviews to be prohibited if they contain (1) certain confidential or private information, (2) libelous or discriminatory content, (3) information unrelated to the business’s products or services, or (4) clearly false or misleading information.  The guide notes that “it’s unlikely that a consumer’s assessment or opinion with which [a company] disagree[s] meets the ‘clearly false or misleading’ standard.”

The CRFA enables both the FTC and state regulators to bring actions for violations.  The FTC may seek civil penalties under existing provisions in the FTC Act or it may seek redress through its administrative court or federal court.  States are enabled to “bring a civil action” for any violation.  Presumably, states would allege that contracts that violate the CRFA also violate their state consumer laws, which provide mechanisms for monetary and injunctive relief.

To be sure, the FTC hasn’t waited for the CRFA to begin enforcement over contract terms that restrict reviews.  In 2015, the FTC filed a lawsuit against a seller of weight loss products that had provided online terms and a package insert restricting negative reviews.  According to the FTC, the package insert stated that each product had been provided at the discount price of $480, and that any negative review would cause the remainder of the full price of $1580 to become due.  The company allegedly threatened to enforce the provision and sued some consumers who posted bad reviews.  The FTC contends in its case that the company’s practices were unfair in violation of the FTC Act.  Litigation is ongoing, and in September, the FTC obtained an asset freeze against the company.

The FTC: Taking Enforcement to Canada?
By Katie Bond

The FTC and Maine recently announced settlements with several related companies and individuals over marketing practices used to sell a joint supplement and a cognitive function supplement.  The complaint and settlement orders in the case may be helpful reading for companies using expert endorsers, telemarketing, free trials, or negative option programs.  However, what struck us as the most interesting aspect of this case was its reach outside U.S. borders.

It isn’t unusual for the FTC to take enforcement action against foreign companies marketing dietary supplements or other products in the United States.  The complaints, however, will describe only the U.S. practices, and only U.S. sales.  For instance, a couple of years ago the FTC took action against a Canadian company that sold a weight loss product in the United States.  The FTC’s complaint carefully noted that the company was located in Canada but had “labeled, advertised, marketed, distributed, or sold [the product] to consumers throughout the United States.”  The complaint also identified only “net sales of [the product] in the United States.”

In the recent case by the FTC and Maine, the allegations veer north.  In describing each corporate defendant, the complaint notes that each advertised or sold products “in this District [meaning Maine], throughout the United States and Canada.”  The complaint likewise alleges that the defendants, all together, sold products “directly to consumers, primarily through radio and print advertising nationwide and in Canada, which has garnered in excess of $6.5 million in gross sales from January 1, 2012 through April 30, 2015.”  A resulting settlement order includes monetary relief in the amount of $6,574,957, which appears to capture both the alleged U.S. and Canadian sales.

It’s difficult to know what led to this settlement reaching sales and marketing practices in another country.  But, one message is clear: there is strategy involved in every step of an investigation and negotiation with the FTC, and every effort must be made to confine an investigation solely to FTC jurisdiction.  Foreign advertising and sales are irrelevant to U.S. business practices and are outside of FTC jurisdiction.

CONTACTS 

John Villafranco
Partner
Washington, DC
(202) 342-8423
Email
Sarah Roller
Partner
Washington, DC
(202) 342-8582
Email
Kristi Wolff
Partner
Washington, DC
(202) 342-8805
Email
Katie Bond
Senior Associate
Washington, DC
(202) 342-8537
Email

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, spoke on Thursday to the DC section of the Institute of Food Technologists.  Responding to questions from the audience, Dr. Mayne was asked to comment on how the Trump administration’s emphasis on deregulation is likely to impact CFSAN’s work.  Speaking generally, Dr. Mayne indicated that there may be opportunities for minor adjustments or tweaks, but stated that she does not anticipate broad rollbacks of the work on which CFSAN has been focused in recent years, largely because the efforts are supported by key stakeholders and implementation is ongoing.  She offered a few examples to support her rationale, including the following:

  • FSMA Rules:  Dr. Mayne noted that FSMA had bipartisan support in Congress along with industry support.  Moreover, given that the agency has finalized seven FSMA rules and implementation is well underway, there may be instances in which specific challenges could be addressed through narrow modifications but broader changes are not anticipated.  As an example of challenges where tweaks may be a possibility, she stated that the agricultural water standards pose unique considerations and could be an area of flexibility.
  • Menu Labeling:  Similar to FSMA, the menu labeling requirements enacted via § 4205 of the Affordable Care Act (ACA) were supported by the restaurant industry and many restaurant chains have already undertaken implementation.  Further, absent national standards, it is foreseeable that states and municipalities could set their own menu labeling requirements – potentially resulting in a state and local patchwork that creates its own compliance challenges.  Although repealing ACA has been the topic of much discussion, she noted that menu labeling is not funded as part of the same budget process and new legislation would be required to repeal it.
  • Nutrition Facts:  Changes to the nutrition facts labels went through multi-year notice and comment and are already being implemented.  Dr. Mayne stated that the agency continues to work through how changes to the nutrition facts labels impact nutrient content and health claims, an issue that she indicated they anticipated.

Dr. Mayne did not comment on the President’s executive order requiring that two regulations be eliminated for every new regulation issued or related cost offset provisions.

Placing Food on the EU Market? Prepare for Potential Regulatory Rollercoaster

In the world of food, 2017 promises to be a busy year across the European Union for regulators and regulated alike.  To the great disappointment of gourmands, farmers and producers, French foie gras exports remain blocked due to spread of avian influenza to wild ducks in France and detection of the H5N8 virus at a French duck farm last week.  At risk are the venerated “frites”, recognized as cultural heritage by UNESCO, which, among other popular foods, are fried or baked at high temperatures that may cause the formation of acrylamide, a toxic substance.  Non-governmental organisations are calling for tougher regulatory controls, which industry fears might affect taste, among other things, and the Commission has been waffling in all directions.  

Confrontations between health advocates, industry groups and national regulators also are running rampant on everything from possible taxes based on sugar content, to “traffic light” food labeling for consumers, to whether foods with pesticide residues may be labeled as “organic.”  Meanwhile, the European Commission is asking the 28 Member States to report on tetrahydrocannabinol in foods that may be present due to the use of hemp as animal feed to facilitate a safety assessment for human consumption of meat and eggs.

The European Parliament has proposed a slate of regulatory actions on food contact materials, including additional safety requirements and expanded risk assessment (see related advisory on Food Contact Materials).  Add to that calls from one of the world’s largest food producers for the Commission to adopt a unified and transparent approach to health and nutritional claims and food labelling to cut inhibiting complexity and bureaucracy and your regulatory plate already will be overflowing.  But that’s not all: the World Health Organisation’s push for implementation of binding rules and imposition of financial sanctions on companies that fail to protect persons under 16 of age when advertising foods high in saturated fats, sugar or salt is sure to have results.  Put on your seatbelts. 

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.”  Today, it announced the beginning of the formal process to make changes to the definition of the term.  The agency opened a new docket and is publishing a Request for Information and Comments relating to use of the term “healthy” in the labeling of human food products.  It also issued a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

Under current regulations, “healthy” can only be used as an implied a nutrient content claim when a food product meets certain nutritional criteria. For instance, most individual food products marketed as “healthy” must be low in fat and saturated fat, must have no more than 480 mg of sodium or the disclosure level for cholesterol, and must contain at least 10 percent Daily Value of one of the following nutrients:  vitamin A, vitamin C, calcium, iron, protein, or fiber.

Companies and experts have noted that this conception of “healthy” is inconsistent with current nutritional guidance, including the 2015-2020 Dietary Guidelines for Americans.  Stakeholders have also asked for clarification on claims that a product can be a part of a healthy diet or is useful in maintaining healthy dietary practices.  In particular, a citizen petition from KIND LLC argues that the current FDA policy “limits the ability of food producers to tell consumers that products containing certain foods – such as nuts, whole grains, seafood, fruits, and vegetables – are healthy, even though they are currently recommended as key components of a healthful diet.”

The Request for Information and Comments also highlights the following questions:

  • Is the term “healthy” most appropriately categorized as a claim based only on nutrient content? If not, what other criteria (e.g., inclusion of foods from specific food categories) would be appropriate to consider in defining the term “healthy” for use in food labeling?
  • If criteria other than nutrient content (e. g., amount of whole grain) are to be included in the definition of the term “healthy,” how might FDA determine whether foods labeled “healthy” comply with such other criteria for bearing the claim?
  • What types of food, if any, should be allowed to bear the term ‘‘healthy?” Should all food categories be subject to the same criteria?
  • Is “healthy” the best term to characterize foods that should be encouraged to build healthy dietary practices or patterns? What other words or terms might be more appropriate (e.g., “nutritious”)? FDA encourages submission of any studies or data related to descriptors used to communicate the overall healthfulness of a food product.
  • What nutrient criteria should be considered for the definition of the term “healthy?”
  • Should nutrients for which intake is recommended to be limited be included? Should nutrients for which intake is encouraged continue to be included?
  • If nutrients for which intake is encouraged are included in the definition, should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population, or should they include those nutrients that contribute to general overall health? Should the nutrients be intrinsic to the foods, or could they be provided in part – or in total – via fortification?
  • Are there current dietary recommendations (e.g., the Dietary Guidelines for Americans) or nutrient intake requirements, such as those described in the final rule updating the Nutrition Facts label or those provided by the Institute of Medicine (IOM) in the form of Dietary Reference Intakes (DRI) that should be reflected in criteria for use of the term “healthy?”
  • What are the public health benefits, if any, of defining the term “healthy” or other similar terms in food labeling?
  • What is consumers’ understanding of the meaning of the term “healthy” as it relates to food? What are consumers’ expectations of foods that carry a “healthy” claim? FDA is especially interested in any data or other information that evaluates whether or not consumers associate, confuse, or compare the term “healthy” with other descriptive terms and claims.
  • Would this change in the term “healthy” cause a shift in consumer behavior in terms of dietary choices? For example, would it cause a shift away from purchasing or consuming fruits and vegetables that do not contain a “healthy” claim and towards purchasing or consuming processed foods that bear this new “healthy” claim?
  • How will the food industry and consumers regard a change in the definition of “healthy?”
  • What would be the costs to industry of the change?

Comments will be due within 120 days of publication of the Request in the Federal Register.

In the meantime, FDA released a guidance document explaining a new policy of enforcement discretion for certain products labeled as “healthy.” In particular, the guidance advises food manufacturers of FDA’s intent to exercise enforcement discretion (i.e., not enforce all elements of the current “healthy” definition) for two new categories of foods:

  • Foods that have a fat profile of predominantly mono- and polyunsaturated fats, but do not meet the regulatory definition of “low fat;” and
  • Foods that contain at least 10 percent of the Daily Value of potassium or vitamin D, rather than vitamin A, vitamin C, calcium, iron, protein, or fiber.

Either type of food should meet the other conditions of a “healthy” claim as set forth in the regulatory definition. FDA will accept public comments on this guidance at any time.

We will be closely monitoring the comments on the use of the term “healthy” and any related FDA action on this significant regulatory change.

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research.  This move is expected to expand and diversify the supply of marijuana for research use.  Under the current policy, the only authorized marijuana manufacturer is the University of Mississippi, which operates under a contract with the National Institute on Drug Abuse (NIDA).  The process for getting access to University of Mississippi marijuana for research through NIDA has been criticized as overly restrictive and slow.   Under the new policy, additional entities may apply to register with DEA; once registered, they would be able to grow and distribute marijuana for FDA-authorized research purposes.

The DEA also released responses to two pending petitions asking the agency to reschedule marijuana.  The petitions had been filed by Bryan Krumm in 2009 and by former Washington Governor Christie Gregoire and former Rhode Island Governor Lincoln Chafee in 2011.  In a letter responding to the petitions, DEA Acting Administrator Chuck Rosenberg explained that Schedule I includes some substances that are exceptionally dangerous and some that are less dangerous.  Rather than being a reflection of relative danger, Schedule I classification is used in the substance has no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.  According to Rosenberg, marijuana currently meets that criteria.

Despite the decision not to reschedule marijuana, DEA clearly expressed support for marijuana research, performed in compliance with the existing rules.  Rosenberg stated that DEA has never denied an application from a researcher to use lawfully produced marijuana in a study determined by the Department of Health and Human Services (HHS) to be scientifically meritorious.  During the last two plus years, the total number of individuals and institutions registered with DEA to research marijuana, marijuana extracts, derivatives, and tetrahydrocannabinols (THC) has more than doubled, from 161 in April 2014 to 354 at present.  According to Rosenberg, NIDA is filling requests for research marijuana in an average of 25 days.  If, based on this research, “the scientific understanding about marijuana changes – and it could change – then the decision [on scheduling] could change,” Rosenberg said.

In December 2015, DEA waived certain regulatory requirements for researchers conducting FDA-authorized clinical trials on cannabidiol (CBD), a constituent part of marijuana that has shown promise in treating a variety of ailments, including seizure disorders.  Earlier, in June 2015, HHS eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana.

To further ease the process for researchers, DEA is building an online application system to apply for Schedule 1 research registrations, including for marijuana.  It also is drafting guidance to assist Schedule I researchers in that application process.  We will continue to monitor the actions of DEA, FDA, and the states with regard to research requirements, pending clinical trials, and steps toward legalization.

Congress Passes National GMO Disclosure Law

On Thursday the U.S. House of Representatives passed S. 764, a Senate-initiated bill establishing a national uniform standard for labeling of bioengineered foods, sometimes referred to as genetically modified foods or GMOs. The law will prevent a patchwork of state standards by preempting inconsistent state laws such as Vermont’s controversial labeling rule, which took effect on July 1 of this year.  President Obama is expected to sign the bill into law shortly.

The bill provides for a national uniform standard for the disclosure of bioengineered foods. Recognizing that label space is limited, in addition to allowing disclosure in text or a symbol on the label, the bill would alternatively allow disclosure through a digital link to a website (i.e., QR code or similar technology). This policy, as we previously wrote, was the result of a compromise between Senate Agriculture Committee Chairman Sen. Pat Roberts and Committee Ranking Member Sen. Debbie Stabenow, and the bill passed both houses with bi-partisan support.

The bill establishes some general contours for the disclosure rules, such as a policy that meat will not be considered bioengineered solely because the animal consumed bioengineered feed, and a carve out for foods served at restaurants. However, specific standards will be set by the Department of Agriculture, which is required to issue implementing regulations within two years of the law’s passage.  We will be closely monitoring those developments.

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