Senators Ask FDA to Update Federal Regulations Governing Use of CBD in Food, Beverages, and Dietary Supplements

  • As previously reported on this blog, the Agriculture Improvement Act (also known as “the 2018 Farm Bill”) removed hemp from the Controlled Substances Act, which means it is no longer an illegal substance under federal law.  However, the 2018 Farm Bill does not affect FDA’s authority to regulate derivatives of cannabis (e.g., CBD) or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs.  As previously mentioned, FDA released a statement clarifying their position on the use of cannabis or cannabis-derived compounds in food and dietary supplements.  In sum, it is still illegal to sell a food or dietary supplement that contains added CBD or THC in interstate commerce.
  • In a January 15, 2019 letter to FDA Commissioner Scott Gottlieb, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) urged the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements. The Senators state that “outdated regulations limits producers from taking full advantage of the industrial hemp market by, for example, prohibiting food products containing CBD from being sold across state lines.”  The Senators note there has been increasing widespread public interest in the production and use of CBD, and that farmers in both Oregon and nationwide are poised to make substantial economic gains should the regulations be updated.
  • As of the time of this blog’s publication, the government has been partially shutdown for 33 days. The Senators recognize that FDA is therefore operating with limited staff, and thus conclude the letter with a request for FDA’s response to the following set of questions within 30 calendar days of the government reopening:
  1. What steps are the agency advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?
  2. What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplement, including into interstate commerce?
  3. Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverages or dietary supplement by the agency?
  4. With the agency consider issuing a regulation, or pursuing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?

USDA and FDA Continue to Call Back Workers Amid Partial Shutdown

  • As previously reported on this blog, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact both the U.S. Department of Agriculture and the U.S. Food and Drug Administration. This blog has also reported that as of January 15, FDA resumed inspections of food facilities that produce high risk foods, such as cheeses, other dairy products, seafood, produce, and infant formula, which had been stopped as a result of the federal government shutdown.
  • On January 20, FDA Commissioner Dr. Scott Gottlieb said in a series of tweets that, as part of the efforts to conduct and support domestic food surveillance inspections of high risk products, a total of 100 investigators and 35 supervisors were called back and that “more staff could be on the way depending on needs.” In addition, FDA’s Office of Import and Enforcement Operations, which covers International Mail Facilities and ports of entry, has about 450 FDA staff in the field supporting critical operations, Gottlieb said.
  • On January 16, USDA announced that 2,500 workers were being called back to reopen about half of its Farm Service Agency (FSA) to provide limited services for farmers and ranchers. Those workers temporarily returned to work on January 17, 18 and 22 to help farmers with existing loans and tax documents. It has also been reported that about 90 percent of USDA’s 9,500 Food Safety and Inspection Service (FSIS) employees remain on the job but are working without pay.

NGO Publishes Report on Food Safety

  • The United State Public Interest Research Group (PIRG) published “How Safe is Our Food? Recent trends and case studies, and what they mean for our health”, a review and commentary of the food safety system in the United States.  PIRG reviewed trends in food safety, with an emphasis on recalls, as well as case studies of seven recent recalls.
  • Of note, PIRG points to the increased number of recalls as evidence that the food safety requirements are not sufficiently stringent.  PIRG acknowledges that the increase in recalls may be due to improved surveillance and testing, but that this “demonstrate[s] that there were previously unidentified problems in the food supply. If the levels of contamination and outbreak being identified were always present and just now being identified, this shows that the safety problems in the food system are still in need of work.”  PIRG also points to large operation farms, the presence of feed lots near vegetable farms, and insufficient regulations and regulatory oversight.  FDA Commissioner Scott Gottlieb tweeted that increased recalls have likely been due to new tools to detect pathogens and that increased complexity of food chains means a single tainted ingredient may result in the recall of many products.
  • CDC, in its Morbidity and Mortality Weekly Report from January 4, published a case study of Whole Genome Sequencing (WGS)used to identify the source of Salmonella in backyard poultry.  The Daily Intake Blog has published many posts about the increased use of WGS, and CDC’s recently published case study is the most recent example of WGS’s use in identifying pathogen sources and the tension between increased recalls/violative product and a safer food supply.
  • For more on FDA’s food safety regulations, see the Daily Intake Blog posts here.  We have also published extensively on food recalls here.

What to Know about California’s New Proposition 12 Requirements on Farm Animal Confinement

  • During the November 2018 election, California voters passed a ballot initiative known as Proposition 12, which establishes new standards for confinement of certain farm animals and bans the sale of products that do not comply with the new confinement standards.  The ballot initiative amended an existing California Health and Safety Code section, Chapter 13.9 (“Farm Animal Cruelty”).  The original law imposed minimum space requirements based on animal movement (e.g., ability to fully extend limbs) for calves raised for veal, breeding pigs, and egg-laying hens, but the new law establishes minimum square footage requirements for the same farm animals.  The law continues to ban products from animals raised in conditions that do not comply with the law.
  • Existing requirements still apply that prevent confining an animal in a “manner that prevents the animal from lying down, standing up, fully extending the animal’s limbs, or turning around freely.”  However, Proposition 12 phases in new requirements that over time, as follows:
    • After December 31, 2019, veal calves cannot be confined with less than 43 square feet of usable floorspace per calf, and egg-laying hens cannot be confined with less than 144 square inches of usable floorspace per hen.
    • After December 31, 2021, breeding pigs cannot be confined with less than 24 square feet of usable floorspace per pig, and egg-laying hens cannot be confined with less than the amount of usable floorspace per hen required by the 2017 edition of the “United Egg Producers’ Animal Husbandry Guidelines for U.S. Egg-Laying Flocks: Guidelines for Cage-Free Housing” or in an enclosure other than a cage-free housing system.
  • Interestingly, animal rights group PETA (People for the Ethical Treatment of Animals) did not support Proposition 12, alleging that the law did not go far enough to protect animal welfare.  Even before Proposition 12, California’s Prevention of Farm Animal Cruelty Act had its share of detractors.  As previously reported on this blog, 13 other states are challenging the law before the Supreme Court.

FDA Resumes Inspections of High-Risk Food Facilities

  • As previously reported on this blog, the partial federal government shutdown stalled FDA’s ability to conduct routine inspections of domestic food facilities.  However, as of January 15, FDA resumed inspections of food facilities that produce high risk foods, such as cheeses, other dairy products, seafood, produce, and infant formula, which had been stopped as a result of the federal government shutdown.  These high risk foods account for about one-third of FDA’s 8,400 annual routine inspections. FDA assesses a food or facility’s risk level by examining a number of factors, including the type of food, the manufacturing process, and the compliance history of the facility.
  • During the shutdown, FDA Commissioner Scott Gottlieb has been communicating via Twitter and press interviews. Commissioner Gottlieb noted that, despite the shutdown, FDA has continued all foreign food facility inspections, and will now resume routine inspections of domestic high-risk facilities. However, inspections of low-risk foods, such as baked goods, will not resume at this time. We note that while much of the Agency’s work is funded by industry user fees, inspections of food facilities are covered by taxpayer money and have therefore stalled. As of the time of this blog’s publication, the government has been partially shut down for 26 days.
  • Commissioner Gottlieb’s staff had been calling the furloughed inspectors to see who would or could come back to work, even though they would not be getting paid. According to the Commissioner, approximately 400 unpaid staff are resuming work during the shutdown. Out of the 400, about 150 employees will be focused on food inspections, with the remaining focus on other aspects of FDA’s mission. The Commissioner praised his workforce, stating “[w]e got an overwhelming response from our very dedicated and mission-driven field force who are coming back to work unpaid.”

Nebraska Bill Defines Meat as Derived from Livestock or Poultry

  • Introduced January 10, 2019, Nebraska Legislative Bill 14 would prohibit “misrepresenting a product as meat that is not derived from livestock or poultry.” The bill, which was referred to the Agriculture Committee on January 14, was introduced by Sen. Carol Blood. “I’m not bringing this bill to tell people what they can and can’t eat. All I’m asking for is truth in advertising. It’s clear that meat comes from livestock, and livestock is our livelihood in Nebraska,” Blood told AP News.
  • Missouri was the first state to limit the use of the term “meat” to products derived from livestock or poultry (see Mo. Rev. Stat. § 265.494(7)). However, as previously reported on this blog, the Good Food Institute (GFI), the Animal Legal Defense Fund, the American Civil Liberties Union of Missouri, and Turtle Island Foods (Tofurky brand) have sued the state of Missouri, claiming the law violates the Free Speech Clause of the First Amendment, among other things.
  • While clean meat (muscle tissue cultured in vitro from animal cells that is also referred to as cell-cultured meat) is not yet commercially available, debates continue to take place on how to regulate it. Tennessee, Virginia and Wyoming have introduced measures to limit the use of the term “meat” that are similar to Nebraska’s LB 14, AP reports. And, the United States Cattlemen’s Association submitted a petition asking USDA to exclude cultured products from the definition of beef and meat (see our July 11, 2018 blog).
  • While FDA and USDA have announced that they will jointly regulate cell-cultured meat products (see our November 19, 2018 blog), details on how these products will be regulated have yet to be determined. In response to a request by FDA and USDA for  public input on the oversight of cell-cultured meat, GFI and seven cell-cultured meat companies jointly submitted comments that stated:
    • “Cell-cultured meat products should thus be required to use meat nomenclatures such as beef, pork, and chicken like their conventional counterparts, as these products will be designed to meet the product-specific characteristics in terms of composition, species, origin, nutritional profile and other applicable characteristics. This is essential to both consumer safety and transparency. Of course, consumers want to know what they are buying, and if cell-cultured meat products were labeled as something other than meat, this would cause confusion and make it harder for consumers to make informed purchasing decisions.”
  • We will continue to report on regulatory activity in this area.

CDC Declares End to Latest E. Coli Outbreak Linked to Romaine

  • As previously reported on this blog, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce. This latest outbreak, which began in the Fall 2018, is not related to the E.coli outbreak that occurred in the Spring 2018. We’ve previously covered the Spring 2018 outbreak, which was officially declared over on June 28 and may have been caused by concentrated animal feeding operations in the Yuma, Arizona area.
  • FDA determined in November 2018 that the Fall 2018 E.coli outbreak was linked to romaine lettuce grown in California during the fall of 2018. Consequently, under an agreement between FDA and a number of grower shippers, grower shippers agreed to label their romaine products with the region where they were grown and the approximate harvest date.
  • In its final update on the Fall 2018 outbreak of E. coli O157:H7 infections linked to romaine lettuce, the CDC declared that the outbreak appeared to be over. In total, from October 7, 2018 to December 4, 2018, there were 62 cases from 16 states and the District of Columbia. CDC previously identified the outbreak strain of E. coli O157:H7 in sediment collected within an agricultural water reservoir on an Adam Bros, Inc. farm in Santa Barbara County. The update notes that FDA is continuing to investigate how the E. coli bacteria could have entered the agricultural water reservoir, ways romaine lettuce from the farm could have been contaminated, and whether there are other sources of the outbreak.

Lapse in Government Funding Continues to Affect FDA, USDA

  • As previously covered on this blog, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact both the U.S. Department of Agriculture and the U.S. Food and Drug Administration. As of the time of this blog’s publication, the government has been partially shut down for over 20 days.
  • Most recently, in a Twitter thread, FDA Commissioner Scott Gottlieb noted that the agency stopped a limited number of domestic food inspections because of the shutdown, but the agency is, “taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities.” Several commodities are deemed “high risk” and include: seafood, soft cheeses, fresh fruits and vegetables, spices, shell eggs, infant formula and medical foods. Gottlieb noted that the mechanism to expand the domestic inspections will be in place beginning the week of January 14.
  • As for the USDA, Senator Debbie Stabenow submitted a letter to the Secretary of Agriculture on January 9 requesting information on the impact that the shutdown is having on the agency, including the delay in implementing the recently-passed Farm Bill. As of the time of this publication, the Secretary has yet to respond. USDA put out a press release at the end of 2018 regarding activities that would be affected by the shutdown, but the department has not updated it since that time.

 

 

 

New York City Considers Warnings for Restaurant Foods High in Added Sugar

  • Following on its 2015 sodium warning regulation, New York City is considering a bill that would require chain restaurants to display a warning symbol and related text next to menu offerings that are high in added sugar.  “Added sugar” is defined as “sugars and syrups put into foods during preparation or processing.”
  • The bill, which was introduced this month, would require a graphic icon and a warning statement (explaining the consequences of excess added sugar consumption) to be provided for menu items that contain more than 12 grams of added sugars.  The bill gives the Department of Health and Mental Hygiene the authority to select the icon and the warning language, neither of which are specified in the bill.
  • If the legislation passes as drafted, restaurants part of a chain with 15 or more locations with the same name and offering substantially the same menu will be subject to the law, which includes civil penalty provisions.

 

Amongst FDA SOI Conversation, Ninth Circuit Agrees Consumers Are Not Misled by Plant-Based Milks

  • The Ninth Circuit upheld the dismissal of a proposed class action that alleged Almond Breeze almond milk is mislabeled and instead should be labeled as “imitation milk.”  Plaintiff Cynthia Painter focused on the nutritional differences between almond milk and 2% dairy milk and argued that the plant-based milk lacked the essential nutrients that are inherent in dairy milk, but are marketed as equally, if not more nutritious.  Indeed, Painter argued that Almond Breeze manufacturer, Blue Diamond, has “deceptively informed and led its customers to believe that they were purchasing, for a premium price, a dairy milk alternative that is nutritionally equivalent, and even superior, to dairy milk.”  Painter further alleged that by calling these almond beverages “milk,” Blue Diamond capitalized on the reasonable consumer’s understanding of the well-known health benefits associated with diary milk without actually providing those same health benefits.
  • In May 2017, Judge Stephen V. Wilson dismissed the case on the grounds of federal preemption and added that “even an unsophisticated consumer, would not assume that two distinct products have the same nutritional content.”  Painter appealed Wilson’s dismissal order, which the Ninth Circuit then upheld on December 20, 2018 via a memo judgement.  The appeals panel said the lower court correctly found that Painter’s state law claims were preempted by the Food, Drug, and Cosmetic Act (FDCA), which bars a state from establishing labeling requirements that differ from federal ones.  Further, the Ninth Circuit said the lower court correctly dismissed Painter’s deceptive marketing claims because she did not plausibly claim that a reasonable consumer would, based on the labeling, believe almond milk and dairy milk to be nutritionally equivalent.  While the Ninth Circuit’s memo judgment offers insight into the court’s thinking on the matter, it does not set legal precedent and cannot be cited by other courts.
  • Notably, the Painter suit focused on the nutritional differences between the beverages, instead of alleged violations of the standard of identity (SOI) for milk.  As previously reported on this blog, industry and certain lawmakers have taken issue with the use of the term “milk” by manufacturers of plant-based products, such as soy milk and almond milk, taking the position that it is a violation of the standard of identity.  Milk is defined as the “lacteal secretion . . . obtained by the complete milking of one or more healthy cows”, though FDA regulations also contemplate milk from other animals.  FDA has begun the process of modernizing SOIs, with a focus on the use of the term “milk” in the labeling of plant-based products. In September 2018, FDA invited interested parties to provide input related to the labeling of plant-based products and in November, FDA extended the comment period, which is now set to close on January 28, 2019.  However, due to the government shutdown, FDA’s SOI modernization efforts will likely be impacted.
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