- In the last two years, the Supplemental Nutrition Assistance Program (SNAP; colloquially known as the “Food Stamps” Program) has been a major point of contention within political circles. For example, the additional SNAP requirements proposed in the 2018 Farm Bill threatened to derail its passage and the United States Department of Agriculture’s (USDA’s) proposal to close a “loophole” that permitted states to rely on eligibility for other programs drew the ire of 70 U.S. mayors.
- There have been ongoing discussions of revisions to the SNAP requirements for the Able-Bodied Adults Without Dependents (ABAWD) program. This program limits ABAWDs to receiving SNAP benefits for no more than three months within a 36-month period unless the individual (1) meets certain work requirements, (2) lives in an area with unemployment over 10 percent or (3) lives in an area that lacks sufficient available jobs. States also have some ability to apply discretionary exemptions and to carry over unused exemptions from prior years.
- On December 5 USDA published a final rule that will limit the definition of “area” to a labor market area (LMA), an intrastate part of a multi-state LMA, or a reservation area or a U.S. Territory. It also defines an area as lacking sufficient jobs when a 24-month average unemployment rate is over six percent and at least 20 percent above the national rate during the same time period. Ability to apply and carry over waivers has also been limited. More on the new rule can be found in the USDA press release, fact sheet, and Question and Answer documents.
FDA Issues Swiss Company a Temporary Permit to Market “Ruby Chocolate” in the United States
- On November 22, 2019, the Food and Drug Administration (FDA) announced that it had issued a temporary permit (TMP) to Barry Callebaut, a Swiss company in accordance with 21 CFR 130.17. The TMP will allow the company to market test a product known as “ruby chocolate.” Although the company has been selling ruby chocolate in other parts of the world, it requires a TMP from the FDA before it could call its product “chocolate” in the United States, as FDA’s standards of identity for chocolate products limit what can be labeled “chocolate.” The FDA’s standards of identity establish the common or usual name for a food, its basic nature, and the types of ingredients that it must contain and may contain.
- Ruby chocolate contains the principal ingredients used in most of the current standards for cacao products under 21 CFR part 163, but it deviates from existing standards of identity for chocolate in terms of its final composition, taste, and color. FDA will not penalize a food that fails to conform to the applicable definition and standard of identity if the company who introduces the food into interstate commerce holds an effective TMP.
- A TMP is a step towards establishing a standard of identity for ruby chocolate under FDA regulations. The TMP allows for the temporary marketing of ruby chocolate, which will allow the Swiss company to evaluate commercial viability of the product and collect data on consumer acceptance in support of a future petition for a new standard of identity. We will continue to monitor any developments.
Proposed Class Action Alleges Company’s CBD Products Violate Federal Law (subscription to Law360 required)
- As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling FDA-regulated products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA alleged that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, causes them to be marketed unlawfully.
- One of the warning letters was sent to Infinite Product Company LLLP DBA Infinite CBD, in which FDA alleged Infinite was marketing unapproved drugs containing CBD. The FDA cited claims on the company’s website that CBD could alleviate symptoms of autism and can treat diseases like hepatitis, cancer, and Tourette’s syndrome.
- On November 27, plaintiff Adam DaSilva filed suit against Infinite Product Co alleging the company sells food, supplement and cosmetic products that are unapproved new drugs in violation of federal law. DaSilva said in the proposed class action suit that Infinite Product’s CBD products are misleadingly labeled and are illegal to sell. In the complaint, DaSilva pointed to the FDA’s recent warning letter to Infinite Products, detailing numerous violations regarding its products, including skin creams and gummies. According to the complaint, there are “[m]any unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD.” Indeed, DaSilva noted that, in a revised Consumer Update, FDA stated that it “is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food.”
- The lawsuit appears to be one of the first private actions filed as a result of FDA’s recent warning letters that allege the use of CBD runs afoul of federal regulations. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.
Farmers Can Now Apply for Federal USDA Hemp Production Licenses
- In addition to establishing requirements for State and Tribal hemp production plans, USDA’s U.S. Domestic Hemp Production Program 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. USDA maintains a list of the status of State and Tribal hemp production plans that are pending approval or have been approved.
- Farmers in states with no plans to regulate hemp themselves and members of Tribes living in states that ban hemp are eligible to apply for a federal license. 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.
- Starting on November 30, 2019, license applications under the federal USDA hemp production plan can be submitted to USDA. As of the time of this publication, copies of the license applications can be requested via email at farmbill.hemp@usda.gov.
11th Circuit Rules for Plaintiffs in Class Action Lawsuit Based on Economic Loss From Purchase of ‘Worthless’ Supplements Containing DMBA – an Impermissible NDI
- We previously reported on a flurry of FDA enforcement actions in 2015 based on adulteration per se, which followed years of relative inaction in the dietary supplement marketing arena outside of enforcement against products with specific health or safety concerns. FDA’s enforcement actions included warning letters to 14 companies regarding the marketing of products that identify the presence of 1,3-dimethylbutylamine or “DMBA” on the product label. Dietary supplements containing DMBA are presumed by law to be unsafe (adulterated per se) because DMBA does not satisfy either of two statutory exceptions for automatically classifying a product containing a new dietary ingredient (NDI) as adulterated. Specifically, DMBA has not “been present in the food supply as an article used for food in a form in which the food has not been chemically altered,” and no manufacturer or distributor has notified FDA of the basis on which such NDI will reasonably be expected to be safe when used as recommended or suggested by its labeling. Such notification (called a NDI Notification or NDIN) must be submitted to FDA at least 75 days before marketing.
- In addition to a risk of FDA enforcement action, products containing a NDI that is not the subject of a NDIN may now also be susceptible to consumer protection class action lawsuits after the 11th Circuit concluded in a November 14, 2019 opinion that the plaintiffs plausibly alleged that they suffered an economic loss when they purchased dietary supplements containing DMBA that were “worthless” because the law prohibits sale of the supplements. The Court of Appeals vacated the dismissal of the DMBA lawsuit by the district court which found the plaintiffs did not suffer economic loss because they received the benefit of their bargain where there was no allegation that the supplements failed to perform as advertised, that the supplements caused any adverse health effects, or that the plaintiffs paid a premium for the supplements. The plaintiffs will now have the opportunity to have their arguments considered by the district court.
- Dietary supplements that contain other impermissible NDIs besides DMBA could also be susceptible to lawsuits based on an identical theory of economic loss. For example, products containing CBD could be at a heightened risk of consumer class action lawsuits under this theory because, as we have reported, FDA has recently taken enforcement action against numerous CBD-containing products. FDA’s current position is that CBD is not a permitted ingredient in conventional foods or dietary supplements, although there is significant pressure on the Agency to develop a regulatory framework that would allow such products to contain CBD.
Senator Gillibrand Announces Bill to Expand FDA’s Investigative Authorities
- As our readers know, this blog has previously covered the romaine lettuce E. coli outbreaks that occurred in the spring and fall of 2018. Ultimately, FDA determined that the outbreak that occurred in the spring of 2018 may have been caused by Concentrated Animal Feeding Operations (CAFOs) in the Yuma, Arizona area, and the outbreak that occurred in the fall of 2018 may have been due to a contaminated on-farm water reservoir.
- On November 19, U.S. Senator Kirsten Gillibrand, D-NY announced her new legislation to help improve food safety across the country. The Expanded Food Safety Inspection Act would expand FDA’s investigative authorities to trace the source of outbreaks of foodborne illness. Under existing law and regulations, FDA is limited to investigating the produce farms from where the outbreaks originated. However, FDA does not have the ability to access nearby farms that may be the source of contamination or that may have contributed to the root cause of a foodborne illness outbreak. As explained in a press release, the Expanded Food Safety Inspection Act would allow the FDA to coordinate with state and local public health organizations, the USDA, and the CDC in order “to better determine the source of outbreaks and give them the authority to investigate contamination from nearby farms.” This would help eliminate sources of contamination directly, decrease the chances of repeated outbreaks within the same region, and facilitate the quick recall of dangerous food products.
- Senator Gillibrand is to introduce the bill in the Senate within the coming weeks. The legislation is endorsed by the Center for Science in the Public Interest and the Consumer Federation of America. We will continue to monitor developments on the Expanded Food Safety Inspection Act
The Daily Intake is taking a break for the Thanksgiving holiday and will return on December 2, 2019. We wish you a wonderful Thanksgiving holiday!
CBD Update: FDA Takes More Aggressive Enforcement Action in Warning Letters to Companies
- On November 25, 2019, FDA issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products cited in the warning letters cover a wide range of forms including oils, drops, dietary supplements, conventional food (including gummies, peanut butter, and water), vape pens, oral sprays, creams, and pet treats. In all cases, FDA alleges that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, causes them to be marketed unlawfully. FDA repeats its long-standing position that CBD is not eligible to be used as an ingredient in conventional foods and dietary supplements, although the letters invite companies to submit evidence to rebut this conclusion.
- FDA also published a revised Consumer Update detailing its continued safety concerns about CBD products more broadly. Notably, for the first time FDA has directly stated that it “is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food.” In a statement, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D noted, “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’”
- These latest warning letters suggest that FDA may be taking more aggressive enforcement action and increasing its scrutiny of CBD-containing products. The statement about the absence of a basis for GRAS status for CBD in food is significant because even if the ineligibility issue can be overcome, FDA’s view is that CBD would need to be the subject of an approved food additive regulation before it could be used in human or animal food.
- The Agency continues to defer fulfilling its commitment to report on its progress in evaluating potential regulatory pathways for CBD products. In its press release discussing the warning letters, FDA states that it now “plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.” Given FDA’s ongoing safety concerns and the present conclusion about the lack of GRAS status in food, it is clear that establishing a regulatory pathway for CBD in food and dietary supplements will need to address numerous significant challenges.
- Keller and Heckman advises clients regularly on the status of CBD in FDA-regulated products. We will continue to monitor FDA’s development of a potential regulatory framework and the direction of additional enforcement action to assess the risks and opportunities for companies marketing these types of products.
Proposed Class Action Lawsuit Alleges ‘Simply Cocoa’ and ‘Made With Real Cocoa’ are False and Deceptive Claims for Hot Chocolate That Contains Alkalized Cocoa
Swiss Miss Hot Cocoa Ingredients Not So ‘Simple,’ Buyers Say (subscription to Law360 required)
- In a proposed statewide class of consumers who purchased Swiss Miss hot chocolate and similar products, an individual has sued ConAgra under various California consumer protection laws. The plaintiff alleges that he made an on-line purchase of Swiss Miss Simply Cocoa Dark Chocolate Hot Chocolate Mix based on his belief that the product contained cocoa in its simplest form as suggested by the name ‘Simply Cocoa’ and the claim ‘Made with Real Cocoa.’ According to the complaint, the product actually contains alkalized cocoa, which the plaintiff alleges is not a simple form of cocoa because it is heavily processed and is inferior to “natural cocoa” in that it has less “real cocoa” taste and reduced levels of healthful antioxidants as compared to non-alkalized cocoa.
- Although the Swiss Miss ingredient statement lists ‘Cocoa (Processed with Alkali),’ which could serve to clarify any potential confusion as to the nature of the cocoa ingredient, it is uncertain whether a “reasonable” consumer would be obliged to check the ingredient statement. As we reported previously, a federal appeals court that reversed the dismal of a lawsuit charging New England Coffee’s Hazelnut Crème coffee violates Massachusetts’ consumer protection laws because the product does not contain hazelnuts found that a reasonable consumer who cared whether the coffee contained real hazelnuts may check the list of ingredients, but “perhaps a reasonable consumer would find in the product name sufficient assurance so as to see no need to search the fine print on the back of the package.” Thus, the fact that the Swiss Miss ingredient statement lists alkalized cocoa may not necessarily undermine the plaintiff’s claims that the terms ‘simple’ and ‘real’ on the front of the package deceptively imply that the product is made with non-alkalized cocoa.
- To the extent that claims against the Simply Cocoa product frame the alkalized cocoa as ‘unnatural,’ the case also raises an issue discussed in our coverage of lawsuits involving ‘natural flavors.’ Namely, is it the degree of processing and not just plant derivation that distinguishes a synthetic from a natural substance and, if so, what level of processing brings an ingredient outside of the realm of ‘natural’? While allegations that the ‘simple’ version of cocoa contains higher levels of ‘healthy’ antioxidants and a different flavor than the alkalized version distinguish the cocoa ingredient from flavor ingredients where ‘natural’ versions are not chemically distinct from ‘synthesized’ versions, the issues involving the extent of chemical processing are still relevant to interpretation of ‘simply’ and ‘real,’ especially as the Swiss Miss product label also claims “no artificial flavors.”
FDA Works to Find Source of Multi-State Outbreak of E. coli Infections
- On November 20, the Centers for Disease Control and Prevention (CDC), in conjunction with the Food and Drug Administration (FDA) and several state agencies, announced that it is currently investigating an outbreak of Shiga toxin-producing E. coli (STEC) O157:H7 infections that has so far impacted at least 17 people across 8 states. The first reported illnesses date back to September 24, 2019. Investigators are looking into a branded chicken Caesar salad as a potential source, after the Maryland Department of Health (MDH) identified E. coli O157 in an unopened package. However, MDH is still conducting a whole genome sequencing (WGS) analysis to determine if it is closely related genetically to the E. coli identified in this outbreak.
- As previously reported on this blog, in January 2019, FDA’s Food Safety and Inspection Service (FSIS) transitioned to using only WGS for Shiga toxin-producing E. coli (STEC) in an effort to update its analytical methods to the state of the art. The method of WGS determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process, and a comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.
- The recent outbreak follows a similar outbreak of E. coli 0157:H7 from 2018 that was ultimately traced to romaine lettuce. The 2018 outbreak included 62 cases from 16 states and the District of Columbia, and prompted FDA to issue recommendations for leafy greens growing operations as well as a partnership between FDA and leafy greens stakeholders in Arizona to enhance food safety. Subsequent research from the U.S. Department of Agriculture’s Agricultural Marketing Service found that pest flies were a potential vector in the spread of the E. coli O157:H7 and contamination of leafy greens.
Former FDA Commissioner Scott Gottlieb Calls for a Ban on Vaping Products Most Widely Used by Youth
- On November 19, 2019, former FDA Commissioner Scott Gottlieb opined on how the FDA should proceed in regulating e-cigs to address the “youth epidemic” but also preserve the devices’ potential to help adult smokers quit cigarettes. Gottlieb argues that “providing adult smokers with a safer alternative to cigarettes cannot come at the expense of addicting a generation of young people to nicotine with these same products.” Gottlieb claims that the FDA must differentiate between cartridge-based e-cigs, which youth prefer, and open-tank vapes that are not popular among youth, as open-tank vapes are sold at higher prices.
- Vaping product advocates argue that FDA restrictions on e-cigs will make it difficult for adult smokers to use the devices to quit cigarettes. These advocates also note that regulatory action to ban flavored e-cigs, which appeal to children, could end up forcing the shutdown of small vape stores where adults shop.
- Gottlieb argues that FDA should immediately remove cartridge-based e-cigs in order to address the youth epidemic, and once the cartridge-based e-cigs are removed from the market, companies that relaunch them would need to file FDA applications showing that they provide a net public health benefit. He explains that this review process would allow FDA to impose additional restrictions to prevent their use by young people. Additionally, Gottlieb notes that FDA should make the premarket tobacco product application (PMTA) process more “efficient” for small businesses that can demonstrate they are only selling products to adults, by, for example, allowing companies following common manufacturing processes to pool data and resources. We will continue to monitor any developments.
