• On October 29, the USDA announced the establishment of the U.S. Domestic Hemp Production Program. As our readers know, the 2018 Farm Bill removed hemp from the Controlled Substances Act and assigned regulation of hemp production to the states with oversight by USDA. The Domestic Hemp Production Program creates a consistent regulatory framework around hemp production throughout the U.S.
  • The USDA also announced it will be publishing an interim final rule that outlines provisions for the Program. As detailed in the interim final rule, a State or Indian Tribe that wants to have primary regulatory authority over the production of hemp in that State or territory of that Indian Tribe may submit, for the approval of the Secretary, a plan concerning the monitoring and regulation of such hemp production. State and Tribal plans developed to regulate the production of hemp must include certain requirements when submitted for USDA approval. Those requirements include:
  1. Land use for production
  2. Sampling and testing for delta-9-tetrahydrocannabinol (THC) to ensure the cannabis grown and harvested does not exceed the acceptable hemp THC level
  3. Disposal of non-compliant plants
  4. Compliance with enforcement procedures including annual inspection of hemp producers
  5. Information sharing for reporting specific information to USDA
  6. Certification of resources
  7. Plan approval, technical assistance, and USDA oversight

Additionally, the interim final rule establishes a federal plan to regulate hemp production by producers in areas where hemp production is legal but not covered by an approved State or Tribal plan. All hemp produced outside of States and Tribes with approved plans must meet the requirements of the USDA plan, which has requirements similar to those under State and Tribal plans, but also requires a USDA hemp producer license. USDA also developed guidelines for sampling and testing procedures that are being issued concurrently with the rule. These documents provide additional information for sampling agents and hemp testing laboratories.

  • Overall, the U.S. Domestic Hemp Production Program will provide clarity to the production of hemp and foster further confidence in hemp products; however, the program will not directly impact the regulatory status of consumer products that contain cannabidiol (CBD). A draft of the interim final rule is available on the USDA’s website. Industry stakeholders may submit comments on the interim final rule once published in the Federal Register, which is likely later this week. Keller and Heckman attorneys would be glad to assist interested parties in preparing comments for submission to USDA or advising on how to comply with the U.S. Domestic Hemp Production Program.

 

  • Missouri was the first among many states, including Arkansas, Louisiana, Mississippi, North Dakota, Oklahoma, South Carolina, South Dakota, and Wyoming, to enact laws restricting plant-based and cell-cultured products from being labeled as “meat.”  As reported here, Turtle Island Foods (Tofurkey brand), in conjunction with non-profit advocacy groups, filed a lawsuit on August 28, 2018, which is the date Missouri’s law took effect, alleging First Amendment violations.  The plaintiffs requested a preliminary injunction on October 30, 2018.  Before a ruling was made on the injunction request, litigation was suspended for negotiations but then resumed in July 2019 after settlement discussions failed.
  • AP News reported on October 4, 2019 that U.S. District Judge Fernando Gaitan Jr. of the Western District of Missouri denied the request for a preliminary injunction because Tofurkey will not be affected by the law in question.  Specifically, as Missouri is not expected to prosecute where a non-meat product label using a defined “meat” term also bears a qualifier, such as “vegetarian,” “plant-based,” or “cell-based,” the Judge found there is no risk of prosecution for the plaintiff and no burden from having to change labels because the current labels disclose that Tofurkey products are plant-based.  A reported statement from Jessica Almy, an attorney in the case and the Director of Good Food Institute (GFI), a co-plaintiff, however, indicates that GFI has appealed the ruling.  In contrast, other plaintiffs in a similar situation will consider dropping a lawsuit in Mississippi upon adoption of a proposed regulation permitting “meat” terms in that state on labels that also use qualifiers.
  • In addition to plant-based products that are the subject of ongoing litigation in Missouri and other states, cell-based products derived from muscle tissue cultured in vitro from animal cells are also targeted by states’ meat labeling laws.  Cell-based products remain in the research and development phase and, thus, are not truly represented in the current litigation against state meat labeling laws.  It is likely, however, that yet-to-be developed federal labeling regulations will ultimately preempt the state laws.  In this regard, we have reported that five cell-based meat and seafood companies have formed a coalition to represent the industry’s interest amidst regulatory uncertainty.
  • As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales). In May 2018, FDA issued a final rule extending the compliance dates to January 1, 2020 for manufacturers with $10 million or more in annual food sales and January 1, 2021 for manufacturers with less than $10 million in annual food sales.
  • In response to recent comments from manufacturers with annual sales exceeding $10 million, FDA announced that it will effectively extend the compliance deadline again by declining to take enforcement actions during the first six months following the January 1, 2020 compliance date. According to a newly published statement from FDA, during this six month period, the agency “plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.”
  • We will continue to monitor developments concerning the compliance date for this rule and will report them to you here.
  • As our readers know, the 2018 Farm Bill removed hemp from the Controlled Substances Act and assigned regulation of hemp production to the states with oversight by USDA. The spring Unified Agenda, released in May 2019, indicated that the hemp production rule was to be released as an interim final rule in August. USDA previously stated that it planned to issue the regulations in late 2019, before the 2020 planting season. USDA has not yet released the regulations.
  • States are anxiously awaiting AMS’s regulations. In a March 2019 webinar and listening session hosted by USDA, several stakeholders expressed concerns about a number of items, including enforcement, reporting regulations, and import requirements for inputs like hemp seed. The Governor of Maine and the Maine Agricultural Commissioner wrote a joint letter to USDA Secretary Sonny Perdue requesting timely action on the regulations and advising him of the regulatory uncertainty’s effects on farmers, agricultural lenders, and insurers.
  • Most recently, at the October 17, 2019 hearing before the Senate Committee on Agriculture, Nutrition, and Forestry, Stephen Censky, Deputy Secretary at the USDA, affirmed that AMS planned to publish the rules soon, and, noted he expects the interim final rule will be available for public comment “within the next couple of weeks.”
  • Despite the delay in releasing the hemp production rule, states have already begun submitting industrial hemp production plans to USDA. Kentucky, Pennsylvania, Tennessee, and Wyoming are among the states that have submitted plans. Other states, including California, Maine, Massachusetts, Missouri, and Texas, have plans to submit after USDA promulgates the federal regulations. States that prohibit the production of hemp, including Idaho, South Dakota, Mississippi, and the District of Columbia, are not expected to submit plans to USDA. Even though the 2018 Farm Bill requires AMS to approve or disapprove state plans within 60 days of receiving them, AMS has indicated that it will not review the plans until their final rule is in place.
  • On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions.
  • As described in the warning letter, the FDA and FTC stated that the company used its website, online store, and social media sites to make unfounded claims about its CBD products, some of which were also unlawfully marketed as dietary supplements. Examples of the claims include:
    • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
    • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
    • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
    • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
  • Additionally, the FTC was concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence that substantiates the claims made.
  • The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. However, as our readers may recall, in July 2019, the FDA announced their commitment to evaluating potential regulatory pathways for CBD products to be lawfully marketed, and that the Agency would report their progress by early fall 2019. As of today’s blog, the Agency has yet to advise on such pathways. Nonetheless, in a press release related to the October 10 warning letter, Acting FDA Commissioner Ned Sharpless, M.D. stated that the CBD-related warning letters “should send a message to the broader market about complying with FDA requirements.” Additionally, he noted that as the Agency continues to examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains top priority.  We will continue to report on developments that impact the use of CBD in FDA regulated products.
  • Toxic metals – such as arsenic, lead, cadmium, mercury and others – occur naturally and as environmental pollutants in air, water and soil and they enter the food supply when plants take them up as they grow. The Food and Drug Administration (FDA) actively monitors the levels of these metals in food and established a Toxic Elements Working Group in 2017 to analyze the data and coordinate FDA’s response. Toxic elements are not necessarily more prevalent in food today than in previous generations, but increasingly sensitive detection methods and the wealth of available data may offer ways to reduce the intake of toxic metals, especially by uniquely vulnerable populations such as infants and toddlers.
  • According to its website, Healthy Babies Bright Futures (HBBF) is an alliance of nonprofit organizations, scientists and donors that designs and implements outcomes-based programs to measurably reduce babies’ exposures to toxic chemicals in the first 1,000 days of development. HBBF’s report, What’s in my baby’s food, released October 17, 2019, identifies the levels of lead, arsenic, cadmium, and mercury found in 13 types of baby food: puffs/snacks, teething biscuits, infant rice cereal, other (non-rice) infant cereal, fruit, vegetables, mixed fruits and vegetables, meats, meals, infant formula, apple juice, 100% fruit juice, and other (non-juice) drinks. As widely covered in the popular press, HBBF reported that 94% of the baby foods contained lead, 73% contained arsenic, 75% contained cadmium, and 32% contained mercury, while 26% of the baby foods contained all four toxic metals.
  • Heavy metals may be a future action item for at least one lawmaker. Senator Chuck Schumer (D-NY) is reportedly calling for FDA to respond to HHBF’s report and to establish standards for heavy metals. The HHBF report urges FDA to:
    • Set health-protective standards for heavy metals, prioritizing foods that offer FDA the greatest opportunity to reduce exposure, considering additive effects of the multiple metals detected in foods, and explicitly protecting against neurodevelopmental impacts.
    • Strengthen and finalize standards for arsenic in apple juice and infant rice cereal, and expand the range of foods covered. HBBF supports recommendations for a 3-ppb inorganic arsenic standard and 1-ppb lead standard that apply to all fruit juice, and a health-protective standard for arsenic in infant rice cereal and all other rice-based foods.
    • Implement a proactive testing program for heavy metals in foods consumed by babies and toddlers, similar to the Consumer Product Safety Commission’s program for children’s toys (CPSC 2019).
    • Ensure lead is not present in food contact materials where it could get into food.
    • Establish a goal of no measurable amounts of cadmium, lead, mercury, and inorganic arsenic in baby and children’s food, in recognition of the absence of a known safe level of exposure, and work with manufacturers to achieve steady progress.
  • FDA has not commented on HHBF’s recommendations.
  • As previously discussed on this blog, there is a National List of Allowed and Prohibited Substances (the “National List”) for synthetic and nonsynthetic nonagricultural (nonorganic) substances that may be used in organic handling, and nonsynthetic substances prohibited from use in organic farming under the National Organic Program (NOP) administered by the United Stated Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS).  The National List is codified at 7 CFR 205.601 through 205.606 and items on the list must be reviewed at least every five years.  The National Organic Standards Board (NOSB) is responsible for reviewing the substances and providing a recommendation to the Secretary of USDA to either renew or remove (only available if 2/3 or more of the members of the NOSB vote to remove at a meeting with a quorum of members) substances on the National List.  AMS, which has been delegated the authority to manage the National List by the Secretary, considers the NOSB recommendation and public comment before making its decision. For more background, see our blog posts here, here, here, here and USDA resources
  • The NOSB held public meetings to discuss the substances that were sunsetting in 2019 on April 19-21 and October 31 – November 2, 2017.  There were five substances reviewed that have already been addressed by AMS (see our blog posts here and here) and on October 8 AMS announced that 24 additional substances on the National List would be renewed without change.  The substances include:
    • Chlorine materials: Calcium hypochlorite, Chlorine dioxide, Sodium hypochlorite (synthetic substance permitted in organic crop production and organic livestock production)
    • Herbicides, soap-based (synthetic substance permitted in organic crop production)
    • Mulches: Biodegradable biobased mulch film (synthetic substance permitted in organic crop production)
    • Boric acid (synthetic substance permitted in organic crop production)
    • Sticky traps/barriers (synthetic substance permitted in organic crop production)
    • Coppers, fixed (synthetic substance permitted in organic crop production)
    • Copper sulfate (synthetic substance permitted in organic crop production and organic livestock production)
    • Humic acids (synthetic substance permitted in organic crop production)
    • Vitamins, C, and E (synthetic substance permitted in organic crop production)
    • Lead salts (nonsynthetic substances prohibited from use in organic crop production)
    • Tobacco dust (nicotine sulfate) (nonsynthetic substances prohibited from use in organic crop production)
    • Glucose (synthetic substance permitted in organic livestock production)
    • Tolazoline (CAS # 59-98-3) (synthetic substance permitted in organic livestock production)
    • Attapulgite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Bentonite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Diatomaceous earth (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Nitrogen (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Sodium carbonate (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Acidified sodium chlorite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Carbon dioxide (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Magnesium chloride (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Sodium phosphates (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Casings (Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic”)
    • Pectin (Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic”)
  • AMS is also reviewing the NOSB recommendations to remove vitamin B1, oxytocin, procaine, and konjac flour from the National List.  Such changes will be announced in a separate rule.
  • On October 11, Mexico’s lower legislative house passed a bill that would require manufacturers to place front-of-pack (FOP) warning labels on food high in sugar, sodium, or saturated fat.  The bill was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) and consists of a draft amendment to the General Labelling Specifications for Prepackaged Foods and Non-Alcoholic Beverages-Commercial and Health Information.
  • Mexico’s current FOP labeling provides information on the quantities of and percent daily values for saturated fat, total fat, total sugars, sodium, and calories in foods.  The proposed amendments would require manufacturers to place an octagonal warning symbol, stating “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.”  While FOP labeling is increasingly common in Central and South American countries, a unique provision of the Mexico bill is that it would also include a warning for foods containing artificial sweeteners, stating “Contains Sweeteners – Avoid in Children.”
  • Those interested in commenting on the draft amendment have 60 calendar-days to submit comments. The bill will now go to the Senate, where it is expected to pass, and then to President Andres Manuel Lopez Obrador, who has expressed support for the bill.
  • The United Food and Commercial Workers (UFCW) International Union, together with Public Citizen Litigation Group, filed a federal lawsuit to stop the USDA’s new swine slaughter modernization rule that eliminates line speed limits in pork slaughter plants, and ultimately gives inspection responsibility to the slaughter plants instead of USDA inspectors.  As we have previously covered on this blog, in September, USDA published the final New Swine Slaughter Inspection System (NSIS), which established that hog slaughter plants may 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 online inspectors would be reduced to a maximum of three per line per shift. The rule also revokes maximum line speeds in processing plants.
  • UFCW is the largest private sector union in the United States, and represents 30,000 pork workers who handle 71% of all hogs slaughtered and processed in the US. The lawsuit alleges that the new NSIS rule violates the Administrative Procedures Act because it is not backed by reasoned decision-making. Additionally, the suit alleges that the rule will hurt pork workers across the country. According to the UFCW, even at current line speeds, swine slaughter and processing workers face risks that can lead to severe injury, illness, and death. Indeed, meatpacking workers are already injured at 2.4 times the rate of other industries.
  • The UFCW suit also alleges that the new rule will significantly impact food safety. For instance, the new rule includes no requirement or funding to train plant employees on inspection techniques that were previously performed by USDA inspectors. UFCW President Marc Perrone stated that “[t]his new rule would also dramatically weaken critical protections that Americans depend on to be able to select safe, healthy food to feed their families every day. The safety of America’s food and workers is not for sale and this lawsuit seeks to ensure this dangerous rule is set aside and these companies are held accountable.”

Kraft Dodges Suit Over ‘No Preservatives’ Capri Sun Label (subscription to Law360 required)

  • A proposed class action, filed in the Northern District of Illinois on October 25, 2018, against Kraft Heinz Food Co. accused the company of falsely advertising its Capri Sun juice as containing “no preservatives” when in fact it contains citric acid. Tarzian et al v. Kraft Heinz Food Company, Case No. 1:18-cv-07148. The complaint alleged that the representation that Capri Sun beverages contain “No Artificial Coloring, Flavors, or Preservatives” is unfair and deceptive advertising as the beverages contain a well-known preservative, citric acid.
  • In an order filed on October 10, 2019, U.S. District Judge Charles P. Kocoras dismissed the lawsuit and found that while the plaintiffs allege practices commonly used to manufacture citric acid throughout the industry, plaintiffs failed to draw a connection between the common industry practice and the actual practice used by Kraft.
  • This dismissal follows a dismissal of a similar matter in California federal court in 2015. Osborne v. Kraft Heinz Group, Inc., Case No. 3:15-cv-02653. In that case, plaintiffs accused Kraft of mislabeling Capri Sun drinks as “all natural” when they allegedly contained synthetic ingredients, including citric acid and natural flavor. In a hearing on the defendant’s motion to dismiss, U.S. District Judge Vince Chhabria found that plaintiff did not know whether the citric acid used in Capri Sun’s drinks was natural or synthetic. The judge ultimately granted Kraft Heinz’s motion to dismiss with leave to amend the complaint. The plaintiff never filed an amended complaint.