FDA to hold public Meeting Regarding Cosmetics Regulation

  • The International Cooperation on Cosmetics Regulation (ICCR) is an international group of cosmetics regulatory authorities including members from Brazil, Canada, the European Union, and the United States.  These members and industry trade associations meet annually to discuss safety and regulatory issues.  The ICCR multilateral framework is intended to harmonize regulations and reduce regulatory burden while maintaining consumer safety.  The next meeting will be held July 9-11 in Montreal, Canada.
  • FDA announced (84 Fed. Reg. 18850 (May 1, 2019)) on May 1 that it will hold a public meeting on June 5 from 2-4 pm in the Harvey W. Wiley Federal Building in FDA’s Center for Food Safety and Nutrition’s College Park, Maryland facility.  Registration for the meeting must be received by May 22 for in-person or phone (listening only) participation.
  • The purpose of this public meeting is to “invite public input on various topics pertaining to the regulation of cosmetics.  [FDA] may use this input to help [FDA] prepare for the ICCR-13 meeting.”  Suggested topics include “proposals for future ICCR agenda items, data, information, or views . . . on issues pending at the public meeting or a topic related to a previous meeting.”
  • More information on ICCR, including FDA notices for public meetings in advance of ICCR-1 through ICCR-13 and transcripts of the public meetings prior to ICCR-8 through ICCR-12, may be found here.

USDA Posts FAQ regarding BE Labeling and Promises Future Guidance

  • The U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) has issued an FAQ for manufacturers concerning its bioengineered (BE) food labeling rule (formally known as the National Bioengineered Food Disclosure Standard (NBFDS)).  The final rule was issued in December 2018 and does not come into effect for several years, but questions are being raised by industry regarding its obligations under the rule.
  • For example, BE labeling is not required if you are processing food using a “validated refining process” or when the food is tested to confirm that genetically modified material is not present.  However, there is little information in the regulations as to what constitutes a validated refining process and what testing would be acceptable to demonstrate that genetically modified material is present or absent in a food.  The FAQ itself is not very helpful in answering these questions; for example, it states, “AMS does not specify which tests must be used, but we provide standards of performance regarding detectability testing methodology.”  That said, it does state that the agency will be providing industry with future guidance on these issues.
  • The FAQ addresses questions ranging from record keeping to how to determine whether BE material is present as a result of inadvertent contamination, which largely tracks information previously provided in the 63-page preamble to the final rule and the regulations themselves.  We have a summary of the NBFDS available here.

FDA Announces “New Era of Smarter Food Safety”

  • On April 30, 2019, Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas announced a “New Era of Smarter Food Safety,” an effort intended to combine the implementation of FSMA with the use of new and emerging technologies. This new approach will start with the development of a “Blueprint for a New Era of Smarter Food Safety,” which will address several areas of food safety, including traceability, digital technologies, and evolving food business models.
    • Food Traceability – According to FDA, food safety is a “never-ending race to detect and respond to problems, while continually assessing better ways to prevent them.” Currently, many in the food system utilize paper-based traceability systems. FDA’s new era of smarter food safety will explore and evaluate new technologies that may upgrade our abilities to rapidly track and trace food through the supply chain. FDA intends for this work to support and align with other trace and track agency efforts, such as the pilot programs focused on tracking the movement of medicines throughout the supply chain.
    • Digital Technologies – FDA intends to also look at how to leverage emerging technologies that are currently being used in other business sectors, such as distributed ledgers, sensors, the Internet of Things, and artificial intelligence. For example, FDA plans to conduct a new pilot that will leverage artificial intelligence and machine learning to explore new ways to enhance the agency’s review of imported foods at ports of entry.
    • Evolving Food Business Models – With the rise of e-commerce food business models, FDA intends to explore areas for collaboration in this space in order to identify the appropriate standard when it comes to food safety challenges and regulatory oversight.
  • The FDA announcement emphasized the importance of collaboration between the private and public sectors to ensure food safety. FDA intends to hold a public meeting later this year to discuss smarter food safety efforts and to seek stakeholder input on FDA’s overall strategy and initiatives. We will continue to monitor and report on any updates regarding the “New Era of Smarter Food Safety.”

USDA Amends National List of Allowed and Prohibited Substances for Organic Handling or Production

  • The United States Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is responsible for maintaining the National List of Allowed and Prohibited Substances (the “National List”) for organic handling and production as part of the National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA; Public Law 101-624, Nov. 28, 1990).  The National List, codified at 7 CFR 205.601 through 205.606, identifies synthetic substances that may be used and natural substances that may not be used in organic crop and livestock production as well as a limited number of non-organic substances that may be used in or on organic processed products.  The National Organic Standards Board (NOSB), a Federal Advisory Board, considers and makes recommendations to the NOP regarding the National List.  For more on the NOP, OFPA, the National List, and NOSB, see our blog posts here, here, here and USDA resources.
  • On April 30, 2018, USDA published a proposed rule to implement recommendations submitted to the Secretary of Agriculture by the NOSB. 83 FR 18744.   Those recommendations were adopted by USDA in a final rule, published on April 30, 2019, which adds elemental sulfur to the National List for use in organic livestock production and reclassifies potassium acid tartrate from a non-agricultural substance to an agricultural substances and requires the organic form of the ingredient when commercially available. 84 FR 18133.

FDA Releases Report on Inspection and Environmental Sampling of Ice Cream Production Facilities for Harmful Bacteria


  • A large number of pathogen-related recalls of ice cream (16 over the three-year period of 2013, 2014, and 2015) and a deadly outbreak of listeriosis in 2015 that was linked to ice cream from Blue Bell Creameries (reported here), spurred a special assignment by the Food and Drug Administration (FDA).  Specifically, FDA conducted inspections and environmental sampling of 89 of the nation’s largest ice cream production facilities in 32 states from September 12, 2016, to August 30, 2017.
  • On April 24, 2019, FDA announced the release of its report on the inspection and environmental sampling of about 16% of the domestic ice cream manufacturers in fiscal year 2017/2017 for Salmonella and Listeria monocytogenes.  FDA’s activity began about a month before larger food facilities were required to comply with the Preventive Controls for Human Food Rule that was established by the Food Safety Modernization Act (FSMA).  No objectionable conditions or practices were found at 44 of the 89 inspected plants.  Listeria monocytogenes was detected on non-food contact surfaces in 19 plants and from a food contact surface at 1 plant.  Salmonella was less prevalent, reportedly detected only from a non-food contact surface and only in one facility.
  • FDA suspended Food Facility Registration for one of the inspected plants, Working Cow Homemade, Inc., after it was linked to a clinical listeriosis case.  After ceasing operations, the firm later resumed business as a warehouse distributor of ice cream products with no production operations.  FDA worked with two other firms to conduct voluntary recalls, held seven regulatory meetings, and notified management at 39 facilities of the need to take voluntary corrective actions.  FDA is also conducting follow-up inspections at all six of the facilities where objectionable conditions or practices warranting official action were observed in the first inspection.
  • FDA’s findings underscore the need for ice cream production plants and other food production facilities to develop and implement a food safety plan.  Please email us at fooddrug@khlaw.com with any questions regarding the Preventive Controls for Human Food Rule or other FSMA requirements.


France Publishes Order Suspending Sale of Foods Containing Titanium Dioxide

  • The French Authorities will suspend the marketing of foods containing (titanium dioxide – TiO2, E 171) as of January 2020. Links below, except the last one, are to the French documents.
  • On April 25, the French government adopted an executive order, implementing the recent Agriculture and Food Law (No. 2018-938). It contains the conclusion from the French Food Safety Agency’s (ANSES) opinion issued on April 15, 2019 showing data gaps and uncertainties regarding the safety of this food additive.
  • The placing on the French market of foods containing titanium dioxide will be suspended for 1 year, as from January 1st, 2020. Manufacturers will not be able to sell or import foods containing TiO2 on the French market, even when they are legally manufactured in another Member State. The EU market rules (i.e. the mutual recognition principle) should not apply and those products will not be permitted  in France.
  • The cost of this suspension will be supported by the entity responsible for marketing the food product in France. The Order – in its current wording – would appear to also cover stocks and products placed on the market before 2020.
  • Titanium remains authorized in other Member States of the EU. But the French “emergency measure” conflicts with the authorization. The issue should be discussed at EU level within the next few weeks. The European Commission should discuss whether the suspension of TiO2 complies with EU Food Legislation and decide eventually whether it should be extended at EU level or not.

CSPI Calls for National Registry of Gene-Edited Agricultural Crops

  • Criticizing the US Department of Agriculture (USDA) and Food and Drug Administration (FDA) for lack of oversight over foods produced with gene editing technology (e.g., Zinc Finger Nucleases, TALENS, or CRISPR/Cas 9), the Center for Science in the Public Interest (CSPI) is calling for a federal registry of all gene-edited agricultural crops.
  • CSPI is not requesting a registry of genetically-modified (GM) agricultural crops, which CSPI notes are subject to government oversight under 7 CFR Part 340 of USDA’s regulations and which are evaluated by FDA under its voluntary plant biotechnology consultation program.  It is focused on gene-edited crops in particular because they have not historically been subject to 7 CFR Part 340 or any other mandatory federal regulations.  According to CSPI, at least 11 developers of gene-edited crops have gone through USDA’s “Am I regulated?” process to inquire into whether they are subject to USDA regulations on GM crops, and all have been informed that they are outside of the scope of those regulations.
  • Consistent with a recent FDA reminder encouraging industry to participate in its voluntary consultation program in part to foster public confidence in the safety of biotechnology, CSPI is encouraging the establishment of the registry to “allay consumer concerns about this emerging technology and allow the benefits of this new technology to be realized.”

FDA Issues Initiation of Voluntary Recall Draft Guidance

  • Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” applies to voluntary recalls of all products subject to FDA’s jurisdiction, including food, drug, and devices intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine under 21 CFR Part 1240.
  • As mentioned in FDA’s press release, the draft guidance includes recommendations in three key areas:
    • Training – The draft guidance emphasizes the importance for firms in a product distribution chain to be “recall ready” to help minimize public exposure to products that are in violation of the Food, Drug, & Cosmetic Act and other laws administered by FDA.  The draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.
    • Recordkeeping – The draft guidance discusses the need for thorough and organized distribution records, that should be maintained over a period of time. Further, the FDA states that products should have specific product coding, whether required by law or not. Product coding assists in facilitating effective recalls and may help a recalling firm accurately define and limit the scope of the recall effort.
    • Procedures – The draft guidance recommends that firms consider preparing and maintaining written recall initiation procedures to help minimize delays, ensure that necessary actions are not overlooked, and minimize the disruptive effect a recall can have on a business. FDA notes in the draft guidance that recall initiation procedures do not supersede any other specific recall plan requirements (e.g., HARPC written recall plans).
  • FDA believes the draft guidance effectuates an important step towards achieving the Agency’s goal of quickly executing recalls and reaching consumers with timely information to limit the impact of potentially dangerous products. Stakeholders may submit comments on the voluntary recall draft guidance until June 24, 2019.  Keller and Heckman attorneys are well-versed in recall procedures and are available to assist interested parties in preparing comments for submission to FDA.  For assistance, please email: fooddrug@khlaw.com

Washington State Bill Restricts Marketing of Degradable Food & Other Packaging

  • The Washington State legislature has passed a bill that restricts the marketing of degradability products, including food packaging and food service ware. The bill, HB 1569, was passed by the senate on April 15 and signed by the Speaker of the House on April 18.
  • HB 1569 specifies that products labeled as compostable must either be comprised only of wood or fiber-based substrate OR must meet the American Society of Testing and Materials (ASTM) composting standard D6400 or D6868. They must also meet Federal Trade Commission (FTC) green guide labeling requirements and be labeled with a logo indicating a third party has certified that the product complies with ASTM specifications. The bill also prohibits labeling of most plastic products with the terms “biodegradable,” “degradable,” “decomposable,” or “oxo-degradable.”
  • Food service products—along with certain film products—that meet ASTM composting standards must be “readily and easily identifiable.” This includes the use of a logo indicating the product has met ASTM standards and the inclusion of the word “compostable” where possible. On the other hand, food service products and film products—including film bags—that do not meet ASTM standards are prohibited from using tinting, labeling, and terms required of products that meet ASTM standards. The bill specifies that manufacturers or suppliers are not required to comply with any of the product labeling requirements that conflict with the FTC green guides.
  • HB 1596 gives the state attorney general, cities, and counties concurrent authority to enforce the labeling and marketing requirements. If the bill is signed by the governor, it will become effective on July 1, 2020.

FSIS Proposes Changes to Net Weight/Net Contents for Some Meat and Poultry Packages

  • In a proposed rule published on April 17, 2019, FSIS proposes to amend its labeling regulations to remove provisions that require packages of meat or poultry products that contain at least one pound or one pint, but less than four pounds or one gallon, to express the net weight or net contents in two different units of measurement on the product label. 84 FR 15989.
  • Currently, under 9 CFR 317.2(h)(5) and 381.121(c)(5), dual declaration is required to express the net weight in ounces and immediately thereafter in parentheses in pounds, with any remainder in terms of ounces or common or decimal fraction of the pound (e.g., “Net Wt. 24 oz. (1 lb. 8 oz.), “Net Wt. 24 oz. (1.5 lbs.)” or “Net Wt. 24 oz. (1 1/2 lb.)”). The proposed rule would eliminate all of the provisions in 9 CFR 317.2(h) and 381.121(c) that require or cross-reference dual net weight or content statements, requiring only one unit of measurement on the product label.
  • Comments on the proposed rule must be received on or before June 17, 2019.

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