• For decades, the United States government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs:
    • The Food and Drug Administration (FDA) regulates GMOs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ensures the safety and proper labeling of GMO-derived foods and feed.
    • The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) — a type of pesticide that is bioengineered into crops — under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed.  EPA also regulates certain biological control organisms under the Toxic Control Substances Act (TSCA).
    • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates GMOs under the Plant Pest Act.  APHIS reviews GM crops to determine whether they meet the definition of a “plant pest” and may pose risks to domestic agriculture.
  • On January 19, 2017, APHIS published proposed revisions to its biotechnology regulations (82 FR 7008).  The proposed rule seeks to update the regulations in a number of areas, all within the Agency’s current statutory authority under the Plant Protection Act.
  • In particular, APHIS is proposing a regulatory program in which it first assesses GE organisms to determine if they pose plant pest or noxious weed risks. If APHIS concludes that a GE organism does not pose a plant pest or noxious weed risk, then APHIS would not require a permit for the importation, interstate movement, and environmental release (outdoor use) of the GE organism. If, on the other hand, the Agency determines based on risk analysis that controls on movement are needed, APHIS would require a permit and work with the regulated entity to establish appropriate permit conditions to manage identified risks to allow safe movement (i.e., import, interstate movement, or environmental release (regulated controlled outdoor use such as in field trials)).
  • In crafting the proposed rule, APHIS considered comments received during public scoping and comment periods related to withdrawal of its 2008 proposed rule, as well as comments relative to a March 2016 notice of intent to conduct a programmatic environmental impact statement, recommendations made in two Office of the Inspector General audits, recent advances in biotechnology, provisions in the 2008 Farm Bill, and the Agency’s accumulated experience in implementing the current regulations. Should the rule proposed on January 19, 2017 ultimately become law, this would be the first comprehensive revision of the regulations since they were established in 1987.
  • APHIS will be accepting public comments through May 19, 2017.  Once the public comment period closes, APHIS will then determine how or whether to finalize the proposed rule based on its evaluation of public comments to the proposed revisions.
  • By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act implemented new requirements applicable to sprout operations.  Sprouts present a unique risk because the conditions under which they are typically produced are also ideal for the growth of bacteria that cause foodborne illnesses.  FDA reports that between 1996 and July 2016 there were 46 reported outbreaks associated with sprouts in the United States, accounting for 2474 illnesses, 187 hospitalizations, and three deaths.
  • Today, the FDA released a draft guidance to help sprout operations meet the new standards set forth under the Produce Safety Rule designed to help keep sprouts free of contamination and safe for consumers to eat.  In general, the Produce Safety Rule sets science-based standards for the safe growing, harvesting, packing, and holding of fruits and vegetables on farms (for produce for human consumption).  The Produce Safety Rule requires, in relevant part, that covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens, test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes, and take corrective actions when needed.
  • The largest covered sprout operations must come into compliance with all applicable provisions of the Produce Safety Rule by January 26, 2017. Covered sprout operations that are small and very small businesses have compliance dates of January 26, 2018 and January 28, 2019, respectively.
  • The draft guidance will be available for public comment for 180 days following its imminent publication in the Federal Register.  Comments received within this time frame will be considered in the development of the final version of the guidance document.
  • As our readership is well aware, the FDA Food Safety Modernization Act (FSMA) has provided the U.S. Food and Drug Administration (FDA) with new authorities to help ensure that imported foods meet the same safety standards as foods produced domestically.  The FSMA regulations concerning imported foods complement FDA’s existing collaborations among food safety regulators (federal, state, local, territorial, tribal and foreign) to achieve public health goals.
  • On January 13, 2017, the FDA announced that it will hold a public hearing on February 14-15, 2017, in College Park, Maryland, regarding strategic partnerships to enhance the safety of food imported into the United States.  The public hearing will provide stakeholders with an opportunity to provide input on the Agency’s activities related to imported foods.  In particular, the hearing is slated to focus on partnerships to:
    • improve safety capabilities through capacity building;
    • partnerships that incorporate information from private entities and foreign competent authorities to inform risk-based decision-making;
    • partnerships that recognize commodity-specific export programs; and
    • partnerships that recognize the robustness of a nation’s entire food safety system
  • The Agency is also seeking information from competent authorities in other countries and from private entities to help inform FDA regarding risk-based decision-making, commodity-specific export control programs in other countries, and systems recognition.
  • Additional information on registering and participating in this public hearing is available here.  Registration ends February 8, 2017.

As previously reported on this blog, FDA issued a revised Draft Guidance titled, “Dietary Supplements: New Dietary Ingredient [NDI] Notifications and Related Issues,” in August 2016. The Agency received more than 7,000 comments on the draft guidance by the Dec. 12, 2016, due date.

  • The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of an NDI to submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (unless the substance qualifies for a narrow exemption). The revised Draft Guidance, updated from the version first issued in 2011, is intended to assist the supplement industry with the NDIN process.
  • Many of the comments from the dietary supplement industry suggest that the 2016 Draft Guidance is contrary to Congressional intent in passing DSHEA and exceeds FDA’s authority. Some of the concerns from industry associations are highlighted below.
    • The American Herbal Products Association (AHPA) stated, “FDA must refrain from declaring or implying that each dietary supplement that contains an NDI requires a separate NDI notification, and should instead encourage manufactures and distributors of new dietary ingredients to include in notifications very broad descriptions of the many dietary supplements that are expected to contain the subject NDI…” In particular, AHPA stressed that changes to manufacturing processes or products specification should not automatically create the need for an NDI Notification.
    • Noting that Congress intended a “lesser” safety standard for NDIs in dietary supplements that do not present a significant or unreasonable risk of illness or injury than the “higher” safety standard of reasonable certainty of no harm under the intended use conditions required for food additives and GRAS substances, the Natural Products Association (NPA) wrote, “FDA continues to blur the distinction between dietary supplements and conventional food ingredients in their testing recommendations.” NPA also recommended that synthetic copies of botanical constituents should not be treated differently from other ingredients when there is no public safety issue.
    • The United Natural Products Alliance (UNPA) suggested that since there were an estimated 77,840 dietary supplements sold in the U.S. and that FDA received a total of 930 NDI Notifications by the end of 2016, “the magnitude of these requirements FDA has proposed is both economically prohibitive for the industry and for a cash-strapped government agency.”
  • As our readership is well aware, Listeria monocytogenesis is a pathogen that causes the infection listeriosis and is the source of numerous food recalls.  See examples of recent recalls caused by Listeria monocytogenes contamination here and here.  Listeria monocytogenes can grow in various settings, including cold, refrigerated environments, and is particularly harmful to the elderly, pregnant women and/or their pregnancy, and those who are immunocompromised.
  • Today, the FDA released an updated draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” which supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenesin in ready-to-eat (RTE) foods. The updated draft guidance has an emphasis on prevention, consistent with the FDA Food Safety Modernization Act (FSMA) and reflects the Agency’s current good manufacturing practice (CGMP) requirements, as well as new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls.  The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill Listeria monocytogenes and formulations to prevent it from growing during storage of the food between production and consumption.
  • Of note, FDA has incorporated industry best practices and the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service (FSIS) into its draft guidance. RTE facilities that produce foods that are regulated by both USDA/FSIS and FDA should benefit from a uniform federal approach to reducing the risk of environmental contamination with Listeria monocytogenesis.
  • FDA will be accepting public comments beginning on January 17, 2017.
  • As reported on this blog previously, comments on a citizen petition from NuTek Food Science, LLC requesting that FDA recognize “potassium salt” as an alternate name for potassium chloride were due last month. Campbell Soup Company and more than 15 other companies and organizations submitted comments supporting the petition. Among the reasons provided by the commenters to allow the use of “potassium salt” on ingredient labels were: (1) consumers want clean labels, and (2) potassium chloride is used as a replacement for sodium chloride, is naturally occurring, and offers health benefits.
  • Campbell Soup’s comments summarized the results of a consumer research study that it conducted, reportedly finding that:
    • Significantly more consumers were concerned about having an ingredient called “potassium chloride” in their soups compared to “potassium salt”
    • Consumers said they were significantly more likely to purchase a soup that contained “potassium salt” over “potassium chloride”
  • As a result of the research, Campbell Soup concluded, “… permitting this alternative name would support companies in their efforts to decrease the sodium content of foods, while also encouraging consumers to increase their intake of potassium, an underconsumed nutrient of public health concern, which also has a beneficial impact on blood pressure.”
  • Only the Salt Institute and an anonymous source submitted comments urging FDA to reject NuTek’s petition. (The comments submitted in response to this citizen petition can be found in Docket No. FDA-2016-P-1826 at regulations.gov.)
  • FDA’s approval of the petition could encourage other ingredient manufacturers to request the use of less “chemical-sounding” name for additional ingredients.
  • As previously covered on this blog here and here, for years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production purposes.  Most recently, in September 2016, FDA announced  that it was “entering the next phase” of efforts to avoid increased antimicrobial resistance by requesting comments on the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes.
  • Against this backdrop, on December 22, 2016, FDA released a report showing that sales and distribution of all antimicrobial drugs approved for use in food-producing animals rose by 1% from 2014 to 2015. The report also showed that the percentage of those antimicrobials that are considered medically important in human medicine increased by 2 percent from 2014 through 2015.
  • Looking ahead, it is possible that the sales and distribution of antimicrobial drugs approved for use in food-producing animals will decrease.  Of note, FDA’s Guidance for Industry #213 established a target date of December 31, 2016 for drug sponsors of antimicrobials used in the feed or water of food-producing animals to voluntarily make changes to affected products to remove production indications (i.e., growth promotion and feed efficiency) and move the products from over-the-counter availability to veterinary feed directive or prescription status.  Provided industry complies with these changes, the use of antimicrobial drugs products for production indications will be illegal and the remaining therapeutic uses for the treatment, control, or prevention of a specifically identified disease will be limited to use under veterinary oversight.
  • Pursuant to Section 201(rr) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, a “tobacco product” is any product made or derived from tobacco intended for human consumption, but excludes drugs, devices, and combination (drug-device) products. A product is a drug, device, or combination product if it is intended to diagnose, cure, mitigate, treat or prevent disease, or if it affects the structure or function of the body (and is not a food).
  • On January 9, 2017, FDA published a final rule entitled, Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses.”  The rule reiterates that a product made or derived from tobacco will be subject to FDA’s drug authority, and not its tobacco authority, if it is intended (a) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction (e.g., smoking cessation), relapse prevention, or relief of nicotine withdrawal symptoms; or (b) to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
  • In our view, this new rule suggests that FDA intends to pursue e-vapor companies making what it perceives to be disease (smoking cessation) or structure/function claims much more aggressively.  Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice and will be closely monitoring developments following publication of this final rule.  To be added to the mailing list for our tobacco & e-vapor regulatory practice, click here.  For more information about our tobacco & e-vapor regulatory practice in general, click here.
  • Register now for Keller and Heckman’s upcoming E-Vapor Law Symposium on February 2-3, 2017 in Washington, DC: VapeMentors.com/fda2017.
  • As previously covered on this blog, on November 22, 2016, FDA issued a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule.  The Agency also issued a related draft guidance document entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)” explaining the Agency’s current thinking on information needed when submitting a citizen petition and the scientific review approach the Agency plans to use for evaluating scientific evidence to determine whether an isolated or synthetic non-digestible carbohydrate that is added to food has a physiological effect that is beneficial to human health.
  • On Friday, January 6, 2017, FDA announced that it is extending the comment period on the fiber documents related to the Nutrition Facts Label. FDA will now provide an additional 30 days to comment on its request for scientific data, information and comments to assist the Agency in determining whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule. The original comment period was set to close on January 9, 2017.
  • FDA has also announced that it plans to provide additional time to comment on its draft guidance entitled “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).” The original comment period was set to close on January 23, 2017. It will now be extended such that it ends at the same time as the comment period for the Agency’s request for scientific data, information and comments discussed above.
  • Keller and Heckman attorneys are well-versed in the nutrition labeling requirements and would be glad to assist interested parties in preparing comments for submission to FDA.
  • As consumers increasingly demand ethically-minded foods such as “Cage Free” and “Pasture Raised”, animal welfare has become a hot-button issue in the food industry.
  • To assist industry with verifying animal welfare standards, on December 27, 2016, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced a program called “USDA ISO TS 34700 Animal Welfare Assessment” under which the Agency will offer assessments of independent animal welfare standards and programs to determine if they conform to the International Organization for Standardization (ISO) Technical Specification (TS) 34700 – Animal Welfare Management/General Requirements and Guidance for Organizations in the Food Supply Chain. By way of background, ISO TS 34700 applies to terrestrial animals bred or kept for the production of food or feed; it was developed to ensure that food producing animals are raised, transported and processed humanely. AMS has indicated that it will work with interested organizations to develop additional program materials including objective, transparent audit checklists. Additional information on the program is available here.
  • Participation in this voluntary AMS program could represent a critical marketing tool for food animal producers given the continuing consumer shift toward humanely raised, ethically-minded foods.