• On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity
  • The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom
  • As discussed previously in this blog, FDA has used its administrative detention power followed by seizure against large volumes of kratom containing dietary supplements
  • In its current press release, FDA stressed the potential dangers of kratom as having opioid-like properties and indicated that there are no FDA-approved therapeutic uses of kratom
  • FDA urged all manufacturers of kratom containing supplements to cease marketing and to submit New Dietary Ingredient Notifications to FDA for kratom prior to marketing

Clients who are interested in pursuing appropriate regulatory status for their dietary ingredients or dietary supplements are invited to contact Mel Drozen at drozen@khlaw.com or 202-434-4222 for assistance.

  • On January 19, 2018, USDA released a proposed rule called the “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process for pork and to allow for the rapid adoption of new food safety technologies in pork slaughter.  Under the proposed rule, hog slaughter plants could voluntarily join a new inspection system whereby establishment personnel would be responsible for sorting and removing unfit animals and identifying defects before FSIS inspection. FSIS inspectors who currently perform this function would be moved to other areas of the plant focused more on food safety. FSIS online inspectors would be reduced to a maximum of three per line per shift.  The rule also specifically proposes to lift caps on line speeds in processing plants.
  • FSIS recently announced that it is extending the comment period for the proposed rule to May 2, 2018 (The original deadline to submit comments was April 2, 2018).
  • If you have any questions concerning the proposed rule, please contact us at fooddrug@khlaw.com.
  • As previously reported on this blog, the U.S. Food and Drug Administration (FDA) released a draft risk profile on the public health risks associated with spices in October 2013. The risk profile identifies the presence of pathogens, such as Salmonella, and filth in spices; describes current efforts to reduce the public health risk posed by consumption of contaminated spices; and identifies control options to prevent contamination.
  • FDA announced on February 15, 2018, the availability of an updated risk profile on pathogens and filth in spice. The updated Risk Profile: Pathogens and Filth in Spices (2017) includes data from an FDA survey that evaluated Salmonella prevalence and aerobic plate counts in packaged (dried) spices offered for sale at retail establishments in the U.S.  The survey showed that the prevalence of Salmonella in nine out of 11 types of retail spices in the U.S. was significantly lower than that for shipments of spices at import. The findings from the study, titled, “Prevalence of Salmonella in eleven spices offered for sale from retail establishments and in imported shipments offered for entry to the United States,” were published in the Journal of Food Protection, Vol. 80, No. 11, in 2017. The study included over 7,000 retail samples of 11 different spice types that were collected during November 2013 to September 2014 and October 2014 to March 2015.
  • FDA requested public comments on the Draft Risk Profile in November 2013. (Materials related to the spice risk profile, including comments submitted, can be accessed from the docket folder, FDA-2013-N-1204.) FDA pointed out that the findings from its recently published survey are consistent with public comments from the domestic food industry stating that responsible manufacturers apply a pathogen reduction treatment to many spices after entering the U.S., prior to retail sale.
  • USDA’s Food and Nutrition Service (FNS) administers the Supplemental Nutrition Assistance Program (SNAP), also colloquially known as the “Food Stamps” Program.  SNAP, through State Agency partners, offers nutrition assistance to more than 47 million eligible, low-income individuals and families.
  • The Trump Administration’s proposed 2019 budget seeks to overhaul SNAP.  In particular, the budget request proposes that more than 80 percent of SNAP recipients would receive about half of their benefits in the form of a monthly America’s Harvest Box with items such as juice, grains, ready-eat-cereals, pasta, peanut butter, beans, and canned fruits and vegetables, which would replace about half of their current SNAP benefits. The remaining SNAP benefits would go on debit cards to be used in grocery stores. (Currently, SNAP beneficiaries get money loaded onto an EBT card they can use to buy any foods that fall under the guidelines). T
  • The Administration is touting the proposed overhaul as a “cost-effective approach” with “no loss in food benefits to participants.” Last year, Congress largely ignored the Trump’s administrations proposed budget for SNAP, when he sought to cut funding by a quarter. 2019 is a farm bill year, however.  This means that many budgetary decisions will be made among the House and Senate agriculture committees. The food industry, of course, has a vested interest in how this all transpires and would likely coalesce to oppose any legislative or policy initiatives that would have the effect of curtailing eligible SNAP products and hence restricting consumer choice.
  • As our readership is well aware, the U.S. Food and Drug Administration (FDA) frequently issues guidance documents for all areas under its regulatory purview, including foods. These guidance documents seek to clarify and supplement existing regulations.
  • On November 16, 2017, Attorney General Jeff Sessions ostensibly expressed a distaste for binding private parties to provisions in guidance documents that have not undergone the rulemaking process.
  • On January 25, 2018, the U.S. Department of Justice changed its policy such that government lawyers will no longer be able to rely on guidance documents to establish civil law infractions.  In other words, going forward under the current Administration, “noncompliance with any guidance document cannot be used to prove violations involving federal civil enforcement actions.”
  • This policy change could have a substantial effect on regulatory actions brought against FDA-regulated entities.
  • As previously reported on this blog, FDA publishes a Food Code every four years that serves as a model for retail and food service regulations nationwide. The Food Code provisions are designed to be consistent with federal food laws and regulations and may be enacted into statute, promulgated as a regulation, or adopted as an ordinance by states or local jurisdictions.
  • On February 12, 2018, FDA released the 2017 Food Code (9th edition). This edition reflects input from regulatory officials, industry, academia, and consumers that participated in the 2016 meeting of the Conference for Food Protection (CFP). Some of the updates to the 2017 version include the following:
    • Addition of the term “Intact Meat,” which means a cut of whole muscle(s) meat that has not undergone comminution, injection, mechanical tenderization, or reconstruction;
    • Revision of the requirement for the Person in Charge (PIC) to be a Certified Food Protection Manager; and
    • Harmonization of cooking time/temperature parameters for intact and non-intact meat and poultry that are in accordance with guidance from the U.S. Department of Agriculture’s Food Safety and Inspection Service.
  • FDA urges state, local, tribal, and territorial regulatory bodies to adopt the latest version of the Food Code, which the agency points out is based on the most current science available. Other advantages—such as promotion of uniform national standards for retail food safety and conservation of resource—are listed by FDA on its website.
  • The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) regulates the quality, safety, and labeling of meat, poultry, and egg products marketed in the United States.  Recently, alternative meat products (known as “clean” meat) produced by culturing cells have become an increasingly hot topic.
  • On February 9, 2018, the United States Cattlemen’s Association (USCA) filed a petition with the USDA’s Food Safety and Inspection Service (FSIS) requesting that the Agency undertake rulemaking on beef labeling to clarify for consumers the difference between beef derived from cattle and “beef” products created in a laboratory.
  • A key question is whether USDA should treat cultured “meat” in the same way as meat produced from raising animals. Not surprisingly perhaps, the USCA petition argues that such products should not be labeled as “beef” or “meat”. In light of the fact that cultured meat is a burgeoning area of food production, we will be closely monitoring regulatory developments as they unfold.
  • The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) work closely to regulate the nation’s food supply. USDA oversees the safety of meat, poultry, and certain egg products, while FDA has authority over all other foods such as dairy, seafood, produce and packaged foods. USDA and FDA partner in many key areas, including produce safety and biotechnology efforts.
  • On January 30, 2018, USDA Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb announced a formal agreement aimed at making the oversight of food more efficient and effective by bolstering coordination between the two agencies. The formal agreement outlines efforts to increase interagency collaboration, to promote efficiency and effectiveness with respect to produce safety and biotechnology activities, and to provide clarity to manufacturers regarding the agencies’ joint efforts.
  • This agreement represents the agencies’ latest initiative to streamline regulatory responsibilities and use government resources more efficiently to protect public health. In particular, the agreement seeks to increase clarity and efficiency and potentially reduce the number of establishments subject to the dual regulatory requirements of the USDA and FDA.
  • For example, an establishment that produces both chicken noodle soup and vegetable soup is currently subject to regulation by both agencies. The agreement tasks FDA and USDA with identifying ways to streamline regulation and reduce inspection inefficiencies while achieving food safety standards for dual-jurisdiction facilities. The successful implementation of this initiative would certainly reduce regulatory burden and costs.
  • 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.  In the meantime, Congress has been considering legislation to modify the menu labeling requirements to provide flexibility in determining how to disclose nutrition information.
  • On February 6, 2018, the U.S. House of Representatives passed The Common Sense Nutrition Disclosure Act, introduced by Reps. Cathy McMorris Rodgers (R-WA) and Tony Cárdenas (D-CA), 266-157, with the support of 32 Democrats. The bill would allow restaurants and grocery retailers the choice of listing calories for the whole menu item, by serving, or per “common unit” of a food item. The bill also provides additional flexibility on where establishments can post calorie information. More specifically, under the proposed bill, nutritional information may be provided solely by a remote-access menu (e.g., an Internet menu) for food establishments where the majority of orders are placed by customers who are off-premises.  The Food Marketing Institute applauded the passage of the bill.
  • Roy Blunt (R-Mo.) has offered a companion bill in the Senate where it likely faces an uphill but not insurmountable battle. The 16 co-sponsors of the Senate bill include three moderate Democrats up for reelection this year — Sens. Heidi Heitkamp (N.D.), Joe Donnelly (Ind.) and Claire McCaskeill (Mo.).  The bill will need to garner the support of at least nine Democrats to pass the Senate.  Given the increasing bipartisan support for this bill combined with the flexibilities afforded to industry under its provisions, The Common Sense Nutrition Disclosure Act (or some variation thereof) may have a chance of ultimately becoming law.
  • As previously covered on this blog, mandatory country of origin labeling (COOL) rules for beef products have long been the subject of controversy and challenge, culminating in: (1) a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and (2) Congress repealing COOL for beef and pork as of December 21, 2015.  Since then, some states have sought to require COOL labeling for beef within their states.  For example, in 2017, Wyoming, South Dakota and Colorado considered state-level COOL legislation, but in each case, the measures were defeated.  And on January 5, 2018, Colorado state legislators introduced a bill titled “Beef Country of Origin Recognition System” also referred to as the “Beef COORS bill” which proposed that “Product of the USA” labels be limited to beef derived exclusively from animals born, raised and slaughtered in the United States.
  • Last week, Colorado legislators rejected the “Beef COORS bill,” voting 10 to 3 in committee to prevent the measure from being debated on the Assembly’s floor by the state’s House of Representatives.
  • The ultimate fate of COOL for beef at the state and federal level remains unclear, particularly since some stakeholders are pushing the Administration to follow through on its campaign promise to create a level playing field for independent domestic meat producers through increasing transparency for consumers, i.e., to have COOL comprise a key element of the Administration’s North American Free Trade Agreement (NAFTA) renegotiations.