FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices

FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices


  • On February 13, 2020, the Food and Drug Administration (FDA) announced the availability of Draft Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.”  When finalized, the guidance document will help industry submit information for efficient consultations with FDA’s Center for Veterinary Medicine regarding both animal feed petitions and GRAS Notices.
  • The draft details what information FDA would expect to review when receiving different requests (e.g., a request to review the adequacy of existing data from a completed study versus a request to review a study protocol).  The guidance also includes FDA timeline “goals” for reviewing certain types of submissions.  For example, FDA’s goal for commenting on a study protocol without method validation or preliminary data is 50 days from the date of submission receipt, whereas the goal for commenting on a study protocol with method validation or preliminary data is 130 days from the date of submission receipt.
  • FDA is accepting comments on the draft guidance through April 13, 2020.  Comments may be submitted here.

Proposed Class Action Lawsuit Claims Arizona Beverage’s Gummies are Not “All Natural” Because They Contain Synthetic Ingredients (Law360 Subscription Required)

  • On February 11, 2020, Christopher Silva, a New York resident, filed a proposed class action lawsuit against Hornell Brewing Co. Inc., Arizona Beverages USA LLC, Beverage Marketing USA, Inc., and Arizona Beverage Co. (“Defendants”) over defendants’ “all natural” gummy snacks.
  • The plaintiff claims that defendants’ advertising and marketing campaign is false, deceptive, and misleading because the gummies contain several synthetic ingredients, such as ascorbic acid, citric acid, gelatin, dextrose, glucose syrup, and modified food starch.  Silva seeks to represent a New York class and individual classes for all 49 other states.
  • In the complaint, Silva cited to the United States Department of Agriculture’s Draft Guidance Decision Tree for Classification of Materials as Synthetic or Nonsynthetic (natural).  Per that guidance, a substance is natural – as opposed to synthetic – if (a) it is manufactured, produced, or extracted from a natural source (i.e. naturally occurring mineral or biological matter); (b) it has not undergone a chemical change (i.e. a process whereby a substance is transformed into one or more other distinct substances) so that it is chemically or structurally different than how it naturally occurs in the source material; or (c) the chemical change was created by a naturally occurring biological process such as composting, fermentation, or enzymatic digestion or by heating or burning biological matter.
  • Silva noted that while the synthetic ingredients are all listed on the back of the package, reasonable consumers are not expected or required to review the ingredients list on the back in order to confirm or debunk defendants’ prominent front-of-the-product claims.  The package in question includes the phrase “All Natural” on the packaging behind the words, “Arizona” and “fruit snacks.” We will continue to monitor any developments.

Trump Administration Proposes to Remove FDA’s Authority to Regulate Tobacco Products

  • As our readers may recall, under the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, FDA has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency deems to be subject to the law.
  • However, on February 10, the Trump administration proposed creating a new federal agency to regulate tobacco products and to remove that authority from the FDA. The administration’s plan is included in their 2021 budget proposal, but to take effect, the budget proposal must be passed by Congress, which appears unlikely given the current political landscape.
  • In sum, the budget proposes to move the Center for Tobacco Products out of the FDA and to create a new agency within HHS to focus solely on tobacco regulation. The new agency would be led by a Senate-confirmed Director. According to the proposal, a “new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity for new tobacco products. In addition, this reorganization would allow the FDA Commissioner to focus on its traditional mission of ensuring the safety of the Nation’s food and medical products supply.”
  • The proposal comes after the head of the White House Domestic Policy Council, Joe Grogan, told reporters last year that tobacco regulation was a “huge waste of time” for the FDA.  Grogan further stated that “tobacco has no redeeming qualities and it should not be regulated by a health agency like this.”  However, public health and policy experts have already criticized the proposal. For example, Matthew Myers, present of the Campaign for Tobacco-Free Kids state that “[i]t has taken a long time for the FDA Center for Tobacco Products to build up the staff, legal expertise and structure to do the job.” Myers elaborated further lamenting that the proposal is “yet another giveaway to the tobacco and e-cigarette industry.”

Supplemental New Drug Application Submitted for FDA-Approved CBD Drug Epidiolex

  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marijuana.” As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under Federal law. However, since CBD has been approved for use in the drug Epidiolex, the Federal Food, Drug, and Cosmetic Act (FD&C Act) has prohibited adding it to a food or a dietary supplement.  Epidiolex is a liquid formulation of pure plant-derived CBD.
  • GW Pharmaceuticals PLC, the manufacturer of Epidiolex, recently submitted a supplemental New Drug Application (sNDA) to expand the label of its Epidiolex cannabidiol oral solution, CV, to include the treatment of seizures associated with Tuberous Sclerosis Complex (TSC). Epidiolex is currently approved in the U.S. for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. The submission is supported by data from a favorable Phase 3 safety and efficacy study conducted in 2019, which showed that Epidiolex reduced TSC-associated seizures by roughly 48% from baseline. The Phase 3 study also demonstrated that the observed safety profile was consistent with data from prior studies.
  • TSC is a rare genetic disorder that causes predominantly benign tumors to grow in various vital body organs such as the brain, heart, kidneys, and lungs. Affecting more than 40,000 people in the U.S. and nearly one million people around the world, TSC is a leading cause of genetic epilepsy today. More than 60% of individuals with TSC are not able to achieve seizure control via standard methods and treatments. The disorder typically manifests in the first year of life and is linked to an increased risk of autism and intellectual disability in children.
  • Epidiolex has been granted Orphan Drug Designation from FDA for the treatment of TSC. According to GW Pharmaceuticals, FDA approval of the sNDA is expected later this year. Epidiolex is GW’s lead cannabinoid product candidate and the first FDA-approved drug that contains a purified drug substance derived from marijuana.

Proposed Amendments to California’s Proposition 65 Warning Regulations

  • In response to stakeholder comments, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify ambiguities in Article 6 of its Proposition 65 (Prop 65) warning regulations.  Prop 65 is a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants.  As summarized here, OEHHA’s final rule amending Article 6 of the regulations implementing Prop 65 became effective in 2018 and imposed requirements on content and methods of transmission, including new Prop 65 warning language.
  • Among other clarifications, the amendments proposed by OEHHA on January 31, 2020 would make it explicit that:
    •  Sales through mobile devices are covered by current Article 6 regulations that require warnings for “internet sales;”
    • The option of providing warnings via an electronic device or a process that automatically provides the warning to the purchaser prior to or during the purchase of a product is only for a “physical retail location;”
    • Product-specific safe harbor warning provisions apply to all products that are subject to specific safe harbor warnings under Prop 65;
    • Product-specific warnings must be provided for online or catalog sales of those products;
    • Foreign language translations of product-specific warnings will be required; and
    • Product-specific warnings (e.g., for food, furniture, etc.) may be provided under the existing regulation on catalog warnings.

There are also several new proposed amendments that apply specifically to alcoholic beverages.  Keller and Heckman has prepared  a full analysis, available here, of OEHHA’s proposed amendments to its Article 6 regulations on Prop 65 warnings.  OEHHA is accepting comments on the proposed amendments through March 16, 2020.

  • Keller and Heckman LLP attorneys actively advise clients on compliance issues and enforcement actions related to California’s Prop 65.  If you have any questions about the amendments to Article 6 or related matters, or would like assistance preparing comments, please email prop65@khlaw.com.

FDA Sampling Survey Interim Data: Frozen Berries

  • The U.S. Food and Drug Administration (FDA) and industry are continually seeking innovative ways to curb foodborne illness outbreaks. As covered previously on this blog, FDA has undertaken a robust surveillance sampling program intended to promote food safety. In 2014, the Agency launched a proactive sampling program for a variety of commodities to learn more about the prevalence of disease-causing bacteria, including identification of patterns that may help predict and prevent future contamination events. The Agency’s sampling approach involves the collection of a statistically determined number of samples of targeted foods over a 12- to 18-month period, and the testing of samples for microbial contaminants.
  • On January 22, 2020, FDA released interim data from its sampling program of frozen berries. As of September 30, 2019, the Agency indicates it has tested 339 domestic samples and 473 import samples of frozen berries. Of the frozen berries sampled, FDA found genetic material from hepatitis A virus in five samples and genetic material from norovirus in eight samples, using multiple-laboratory validated RT-qPCR methods for the detection of those viral sequences in soft fruit. These 13 samples were then further tested by the “Sanger sequencing” method to see if the viral material could be further characterized by examining a separate, distinct section of the viral genomes. Nine of the 13 samples could be further characterized using this technique. Upon detection of genetic material from hepatitis A virus or norovirus in a sample, the Agency notified the firm of the findings and worked with them to take appropriate action to protect the public health.
  • The information released is interim data, and FDA indicates that testing remains ongoing and no conclusions can be drawn at this time.

Washington State Lawmakers Sponsor Bill Requiring Retailers to Mark Meat as Either “USA Beef” or “Imported”

  • Twenty-seven Washington State lawmakers have sponsored House Bill 2712, which would require the state’s retailers to mark meat as either “USA beef” or “imported.” House Bill 2712 would require grocery stores to post a “conspicuous placard” by the “USA beef” and another one by the “imported” beef.  To qualify for the USA beef label, beef must come exclusively from animals that were “born, raised, and processed in the United States” or “ born and raised exclusively in the United States and transported for a period of time not more than sixty days through any other country and slaughtered in the United States.”
  • Rep. Joel Kretz, the prime sponsor and member of the House Rural Development, Agriculture and Natural Resources Committeestated that he is sponsoring the bill this year because beef producers in Washington have higher standards, more safety protocols and quality controls. In addition to the lawmakers, the Washington Fair Trade Coalition, which consists of members including labor, health, environmental, faith-based and social-justice groups, endorsed the bill.
  • Representatives of feedlots and packers stated that a state labeling law would harm relationships with Canadian producers they need.  The Washington Cattlemen’s Association also opposes the bill. We will continue to monitor any developments.

FDA Approves Drug to Treat Peanut Allergy in Children

  • On January 31, FDA approved the first drug to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. The drug, Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] may be given to individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy. However, FDA warns that those who take Palforzia must continue to avoid peanuts in their diets.
  • Peanut allergy is a condition in which the body’s immune system mistakenly identifies even small amounts of peanut as harmful. Allergic reactions to peanut are unpredictable in occurrence and in how they present. Physical symptoms can develop within seconds of exposure and may include skin reactions (e.g., hives, redness or swelling), digestive discomfort, or more dangerous reactions, such as constriction of the throat and airways, and loss of adequate blood flow to vital organs of the body. As per the FDA press release, Palforzia may be used to mitigate reactions, but cannot be used for the emergency treatment of allergic reactions.
  • According to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, peanut allergy affects approximately 1 million children in the US. Only 1 out of 5 of children will outgrow their allergy. There is no cure for peanut allergies and therefore those who are allergic must strictly avoid exposure. Hence, the importance of allergen labeling. As our readers know, under the Food Allergen Labeling Consumer Protection Act (FALCPA), all packaged foods are required to label the presence of a “major food allergen.” FALCPA identifies 8 foods or food groups as the “major food allergens,” including peanuts. The 8 major food allergens identified by FALCPA account for over 90% of all documented food allergies in the US and represent the foods most likely to result in severe or life-threatening reactions.

In the Wake of Heightened Regulatory Scrutiny of Vaping Products, Nicotine-Containing Toothpicks are Next to Come Under Fire by FDA

  • The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused birch toothpick products in different flavors, including “Peppermint Ice,” “Wintergreen,” and “Cinnamon” Nicotine Toothpicks.  FDA’s warning letter focused on the following, specific violations: (1) selling a tobacco product to a minor through the company’s website;  (2) selling unauthorized modified risk tobacco products; and (3) failing to include required nicotine addiction warning statements on both packaging and advertising. In making the illegal sales finding, FDA cited the fact that a person younger than 18 years of age was able to purchase Peppermint Ice Nicotine Toothpicks from the company’s website. The company’s website also contained some advertising claims that came under scrutiny as modified risk claims because they represented that the product presents a lower risk of tobacco-related disease or is less harmful than other commercially marketed tobacco products (such as its website claims, “Nicotine Satisfaction without smoke damage to your lungs” and “Smart Toothpicks – A catalyst to promote a healthier way of life… in a flavorful way!”). The products were also found to be misbranded because both the website and the product packaging were missing the required nicotine addiction warning statement.
  • This action provides an illustration of the Agency’s interpretation of “tobacco product,” which FDA defines broadly as any product made or derived from tobacco that is intended for human consumption. The Agency takes the position that this definition includes novel, non-tobacco products that contain nicotine derived from tobacco, such as nicotine-infused toothpicks. Referring to the nicotine-infused toothpicks as “dissolvable tobacco products,” the Agency concluded that the products are “covered tobacco products” under 21 C.F.R. § 1140.3, and thus subject to the same FDA requirements as other deemed products, including sales restrictions to minors and marketing authorization requirements.
  • This action also signifies the extensive reach of FDA’s regulatory authority, and highlights to others in the growing novel nicotine products industry that FDA remains focused on holding retailers and manufacturers accountable for marketing and sales practices that can lead to increased youth appeal of tobacco products.  In fact, FDA has gone on record to state that it is increasingly focused on “novel nicotine-containing products” as one such way to facilitate youth access and nicotine addiction. Accordingly, others in the industry would be prudent to heed this warning and ensure full compliance with FDA regulations, including heightened age verification for online sales and reviewing product advertising and any use of non-tobacco flavors appealing to minors.

Be sure to register for Keller and Heckman’s E-Vapor and Tobacco Law Symposium on February 11-12, 2020 in Irvine, California.  Details and Registration information can be found here.

USDA AMS Solicits Comments on Draft Instructions for Testing Methods to Confirm the Absence of Detectable Modified Genetic Material


  • As previously covered on this blog, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) implements the National Bioengineered Food Disclosure Standard (the Standard).  On January 1, 2022, which is the mandatory compliance date for the rule, regulated entities must disclose whether food offered for retail sale is bioengineered (BE) or uses BE food ingredients.  The regulatory definition of “bioengineered food” excludes foods where modified genetic material is not detectable and USDA’s regulations discuss “detectability” at 7 CFR 66.9.  In the issuing the final rule, USDA AMS indicated it would provide further instructions on two of the provisions by which a regulated entity can determine that modified genetic material is not detectable: (1) acceptable testing methodology and (2) validating a refining process.  As we reported, USDA AMS released draft instructions for validation of refining processes on December 17, 2019.  Today, USDA AMS released for comment its draft instructions regarding acceptable testing methodology.
  • The draft instructions for acceptable testing methodology describe factors to consider when selecting a test method that is fit for the purpose of demonstrating that a food does not contain detectable modified genetic material.  The draft instructions state that entities should use validated methods accepted by international bodies (e.g., International Organization for Standardization (ISO) and Codex Alimentarius Commission (Codex)) and/or validate their own methods.  The following international standards are referenced:  ISO 24276 Foodstuffs -Methods of analysis for detection of genetically modified organisms and derived products- General requirements and definitions, ISO 21571 Nucleic Acid Extraction, ISO 21569 Qualitative Nucleic Acid Analysis, ISO 21570 Quantitative Nucleic Acid Analysis, and Codex document CAC/GL 74-2010 Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA Sequences and Specific Proteins in Foods.  Additionally, the instructions address DNA-based methods (e.g., polymerase chain reaction (PCR) methods both qualitative and quantitative are noted as being “acceptable”), emerging technologies, and other methods, as well as general considerations in selecting a laboratory and record keeping requirements.
  • Comments on the new draft instructions are due by March 4, 2020.  After USDA reviews the comments received they will publish final instructions on testing methods on their website.  Keller and Heckman has the legal and scientific expertise to assist you as you implement your validated testing methods for your refining processes. We will continue to monitor and report on developments that impact BE labeling.



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