• FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here.
  • On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) to help small businesses comply with the Produce Safety Rule mandated by FSMA. In particular, the SECG is designed to help farmers determine whether they are eligible for a qualified exemption, which would modify the requirements they are subject to under the Produce Safety Rule.
  • The main compliance dates for small businesses and very small businesses under the Produce Safety Rule are January 28, 2019, and January 27, 2020, respectively, but certain agricultural water requirements have extended compliance dates (see previous blog coverage here). Sprout operations also have different compliance dates, and sprout operations that are small businesses and very small businesses have compliance dates of January 26, 2018, and January 28, 2019, respectively. Businesses that intend to claim a qualified exemption by their primary compliance date were required to begin keeping documentation supporting their eligibility for a qualified exemption on January 26, 2016.
  • Manufacturers or distributors of new dietary ingredients (NDIs) must 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 (i.e., one not marketed in the U.S. prior to October 15, 1994).  On August 12, 2016, FDA issued a revised Draft Guidance on NDIs and NDINs.  The guidance addresses the circumstances under which an NDIN is required, the contents of an NDIN, and the process and timeline associated with NDIN submission and review.  Of note, FDA indicated in the draft guidance that it was willing to develop an authoritative list of dietary ingredients that were marketed before October 15, 1994, and consequently exempt from the NDIN requirements in DSHEA.
  • Today, FDA announced in a Federal Notice (82 FR 42098) that it will hold a meeting on October 3, 2017 to discuss its future development of an authoritative list of old dietary ingredients exempt from notification requirements in the law.  The meeting is slated to address two distinct issues that have elicited various opinions among stakeholders:
    • The standard of evidence required to show an ingredient belongs on the pre-DSHEA list; and
    • The process by which ingredients should be added to the list, such as the process for nominating and reviewing pre-DSHEA ingredients and how to treat confidential information.
  • FDA states in the Notice that “by providing clarity as to which ingredients do not require notifications, it would alleviate the burden on industry of preparing and submitting unnecessary notifications.” FDA further states that “by eliminating unnecessary notifications, an authoritative list would enable [the Agency] to more efficiently use [its] limited resources to review notifications for truly ‘new’ ingredients. In addition, an authoritative list would allow [the Agency] to better focus [its] enforcement efforts in alignment with [its] strategic priorities of consumer safety, product integrity and accurate information.”
  • The registration deadline for the October meeting is September 25, 2017.  FDA recommends early registration as seating is limited.  To register for the public meeting, click here.
  • FDA will allow interested parties to comment on the public meeting by submitting electronic or written comments through December 4, 2017. Keller and Heckman LLP has significant expertise in advising the dietary supplement industry.  Interested parties with any questions regarding the upcoming meeting or who would like assistance in preparing comments regarding the development of a list of Pre-DSHEA dietary ingredients are encouraged to email us at fooddrug@khlaw.com.
  • As previously reported on this blog, there is an ongoing debate on whether the use of the term “milk” by manufacturers of plant-based products—such as soy milk and almond milk—is a violation of milk’s standard of identity. On one side of the debate, the dairy industry has called on FDA to crack down on the use of dairy-related terms for plant-based products. In January 2017, Senator Tammy Baldwin (D-WI) introduced the DAIRY PRIDE Act, which would have required non-dairy products made from nuts, seeds, plants and algae to no longer be mislabeled with dairy terms such as milk, yogurt or cheese (for more details see our January 31, 2017 blog); but no action was taken on the bill before the end of the 2016/17 Congressional session.
  • On the other side of the debate, the Good Food Institute (GFI) submitted a petition to FDA in March 2017 requesting that the Agency issue a regulation clarifying that “new foods may be named by reference to other ‘traditional’ foods in a manner that makes clear to consumers their distinct origins or properties.” The group specifically mentioned in the petition that a significant and growing group of consumers has sought to reduce or eliminate dairy product from their diet and that plant-based alternatives to traditional dairy products are becoming more common.
  • In a letter dated August 29, 2017, FDA told GFI that it had not reached a decision on the petition within the first 180 days of its receipt due to other competing priorities. The Agency added, “We will complete our review of your petition and consider any amendments to our regulations as warranted in the context of other program priorities within the Center.”
  • Despite requests from both sides for FDA to weigh in on the plant-based milk labeling controversy, the recent letter to GFI does not give any indication of when FDA will address this issue.
  • Avocados are trending.  From avocado oil and avocado ice cream to avocado toast and guacamole, avocado consumption in the U.S. is at an all time high.  Food Dive reports that the average weekly U.S. avocado consumption of 42 million pounds has nearly doubled in the past three years and is projected to hit 50 million pounds per week in 2019.
  • According to research from Tufts University published in the journal Nutrients in August, eating one fresh avocado daily for six months improved working memory and problem-solving skills in 40 healthy adults aged 50 and older.
  • Another recent study, reported by Ingredients Network, found that avocado seed husks – which are typically tossed out with the seed – contain chemical compounds with potential value in medical and industrial applications. For example, the researchers identified chemical compounds in the avocado seed husk oil that could potentially be employed in anti-viral medications and tumor cell inhibitors. In the wax, the researchers detected a plasticizer that promotes flexibility in synthetic products including shower curtains and medical devices, a cosmetic chemical, and butylated hydroxytoluene (BHT).
  • These recent studies are likely to further enhance avocado’s well-established nutritional reputation and popularity among American consumers.
  • A new Ecommerce Supermarket Scorecard reports that total online grocery sales are growing year-over-year at 25%. The Supermarket Scorecard also suggests that, in general, customer confidence in online shopping is growing.
  • Other highlights from the Supermarket Scorecard include:
    • The average value of customer orders increased over the previous year by more than 5;
    • About 85% of online transactions included produce items;
    • Meat/seafood and deli were found in more than 66% of the transactions;
    • Bakery was found in almost 50% of the transactions; and
    • For companies that offered both options, customers preferred to receive their offers by delivery (74%) over click-and-collect (26%).
  • The study was conducted over a four week period in March of this year and included nearly 200 stores.
  • As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production.
  • To facilitate compliance with the new requirements, FDA has been in the process of rolling out a comprehensive draft guidance document for industry, in stages, entitled, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”.
  • Today, the FDA announced the availability of the sixth chapter of the draft guidance for food facilities that explains how to establish and implement a heat treatment, such as baking or cooking, to prevent contamination by disease-causing bacteria.
  • FDA indicates that it intends to publish at least 14 chapters altogether and will continue to announce the availability of each chapter as it becomes available.
  • As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 29, 2018.  The law requires the USDA to have conducted a study by July 29, 2017 to identify “potential technological challenges that may impact whether consumers would have access to the bioengineering disclosure through electronic or digital disclosure methods.” The law also requires that USDA solicit and consider comments from the public concerning the study.
  • The Center for Food Safety has repeatedly expressed concerns that any electronic communication will not provide disclosure to a large portion of Americans and will disproportionately affect minority, low-income, and elderly people, who are less likely to own smart phones. In a suit filed on August 25, 2017, the Center for Food Safety alleged that USDA has violated the Administrative Procedures Act because it has “failed to publicly release the study, or provide for public comment on it.” The complaint further states that, “[b]ecause the results of the electronic/digital link study are a necessary precursor to the development of the final rules, further delay of this process is likely to delay the rules themselves.”
  • The complaint asks the court to establish a court-ordered timeline for USDA to conduct and publicly publish the study, as soon as reasonably practicable, and to solicit and consider public comments.
  • Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items. The menu labeling requirements originally were scheduled to take effect on December 1, 2015. The compliance date has since been delayed until May 8, 2018.
  • On August 25, 2017, FDA Commissioner Scott Gottlieb issued a statement in support of the menu labeling rule and announced that additional guidance would be issued by the end of this year to provide further clarity on regulatory compliance obligations under the new requirements.
  • On the same day, New York City agreed to delay its local menu labeling requirements. More specifically, New York City has agreed not to fine or sanction businesses for alleged non-compliance with calorie and nutrient information menu-labeling requirements before the May 2018 compliance date established by FDA. The Food Marketing Institute (FMI), and the National Association of Convenience Stores (NACS) had sued New York City for the decision to enforce its own menu labeling law prior to the federal compliance date, but the trade associations have now settled the lawsuit.
  • In a statement praising the FDA Commissioner’s statement, the Center for Science in the Public Interest (CSPI), urged Congress to reject legislation aimed at providing flexibility to establishments subject to the menu labeling rule.  See previous blog coverage of this legislation here.
  • We will continue to monitor developments concerning FDA’s menu labeling rule as they unfold and report them to you here.
  • On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule.
  • In short, the final rule establishes various food defense measures that registered facilities are required to implement to protect against the intentional adulteration of food.  As a general matter, facilities must prepare and implement a written food defense plan that identifies significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification.  Facilities also have new training and recordkeeping requirements under the final rule.  Several types of facilities and activities are exempt from compliance.  Specifically, the new requirements do not apply to:  (i) very small businesses; (ii) the holding of food, except the holding of food in liquid storage tanks; (iii) the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact; (iv) activities that fall within the definition of “farm”; (v) animal food; (vi) alcoholic beverages under certain conditions; and (vii) certain on-farm food/activity combinations performed by small or very small businesses.
  • On August 24, 2017, the FDA announced the availability of a Compliance Guide to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.
  • The Compliance Guide was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. The Guide provides nonbinding recommendations on topics including, but not limited to:
    • Who must comply with the rule and when;
    • Developing a food defense plan;
    • Records management; and
    • Education, training and qualifications.
  • The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Keller and Heckman actively advises on FSMA compliance matters and stands ready to assist interested parties in this regard.
  • USDA Animal Care is a component of the Department’s Animal and Plant Health Inspection Service (APHIS). Animal Care works with states, regulated industries, animal advocacy groups and other non-governmental organizations to support the welfare of millions of animals across the U.S.
  • In July 2016, APHIS formally initiated a comprehensive review and update of Animal Care’s website, publications and correspondence to eliminate out-of-date content and improve the information provided. As part of this review, the Animal Care database was taken off-line beginning on February 3, 2017. The removal of this data from the public domain was widely covered in the press, and led People for the Ethical Treatment of Animals (PETA) and other animal welfare advocates to file a lawsuit against the USDA on February 13, 2017 to compel the Agency to return to its website all records related to animal welfare enforcement.
  • On August 18, 2017, APHIS announced that it would be launching a refined public search tool (a component of the Animal Care Information System (ACIS)) to provide access to Animal Welfare Act compliance records. The refinements to the ACIS search tool are detailed in this chart.
  • The refined ACIS search tool provides information on APHIS’ performance of its statutory duties under the Animal Welfare Act. The search tool is available here. APHIS notes that the public may also request additional Animal Welfare Act records from APHIS through the Freedom of Information Act.