- As we have previously covered on this blog, on February 1, 2018, FSIS put forward a proposed rule to establish a voluntary, opt-in inspection system for market hog slaughter establishments, called the New Swine Slaughter Inspection System (NSIS). The proposal had received pushback from consumer groups and several media outlets, with FSIS defending its proposal in a direct response to a Washington Post article earlier this year.
- On September 17, 2019, FSIS released the final rule establishing the NSIS. Under the final rule, 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.
- In a press release, USDA Secretary Sonny Perdue stated: “The final rule is the culmination of a science-based and data-driven rule making process which builds on the food safety improvements made in 1997, when USDA introduced a system of preventive controls for industry. With this rule, FSIS will finally begin full implementation of that program in swine establishments.”
Mitch McConnell Introduces Bill Amendment That Would Compel FDA to Issue CBD Enforcement Discretion Policy
- Senate Majority Leader Mitch McConnell (R-KY) has introduced language into a Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).
- The amendment, which was shared with the U.S. Hemp Roundtable, would require FDA to provide Congress with a report on how it will develop its enforcement discretion policy and how it will evaluate CBD for use in FDA-regulated products within 90 days of passage. Within 120 days, FDA would be required to issue its enforcement discretion policy for CBD.
- The market for CBD products is rapidly increasing, and the regulation of CBD in foods and supplements has not kept pace. McConnell has shown a great interest in limiting the regulatory uncertainty faced by hemp farmers in his state of Kentucky, where hemp production is replacing tobacco production.
FDA Announces Public Meeting to Discuss “A New Era of Smarter Food Safety”
- FDA will hold a public meeting on October 21, 2019 to hear from a broad cross-section of stakeholders on their new food safety approach, called “A New Era of Smarter Food Safety.” The new approach is intended to combine the implementation of FSMA with the use of new and emerging technologies, like blockchain, sensor technology, the Internet of Things, and artificial intelligence. FDA is working towards enhancing its ongoing efforts to implement FSMA by creating a more digital, traceable, and safer system to help protect consumers from contaminated food.
- At the meeting, the public will have a chance to discuss and comment on FDA’s new approach to food safety and the input received both at the meeting and in comments submitted to the accompanying Federal Register docket will help shape the FDA Blueprint for a New Era of Smarter Food Safety. As our readers may remember, the Blueprint will outline how FDA plans to address several areas of food safety, including traceability, digital technologies, and evolving food business models. FDA intends for the strategic plan to outline how this new approach will address public health challenges, including being able to trace sources of contaminated foods and using new predictive analytics tools to assess risks and prioritize the agency’s work and resources.
- Persons interested in attending the public meeting either in-person or by webcast must register online by October 11, 2019. The deadline to submit written/electronic comments is November 20, 2019. Keller and Heckman attorneys are well-versed in FSMA and food safety requirements and stand ready to assist interested parities in preparing comments for submission to FDA.
FDA Issues Draft Guidance on Reconditioning Fish
- The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry, titled, “Reconditioning of Fish and Fishery Products by Segregation.” This draft guidance explains two potential approaches to separating non-violative portions of fish and fishery products from portions that are adulterated due to pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The two approaches to reconditioning adulterated fish and fishery products, described in the draft guidance, are:
-
- Segregation based on a production-related rationale supported by production records identifying the cause of the adulteration and its restriction to only a portion of the article along with sampling and testing to confirm that the segregation was successful; or
- Segregation based on the results of statistically significant sampling and testing.
-
- These approaches can be used if they satisfy the requirements of the applicable statutes and regulations but do not apply when reconditioning is proposed by means other than segregation, such as be cooking or conversion to animal feed, according to FDA (84 Federal Register 48935). Although, the Agency cautions that anyone introducing, delivering, or receiving fish and fishery products in interstate commerce is ultimately responsible for ensuring that the food is safe and complies with all applicable laws and regulations.
- FDA has requested feedback on the draft guidance. The comment period will be open for 60 days until November 18, 2019. Electronic comments can be submitted on https://protect-us.mimecast.com/s/VHGXCmZEzmSj03MjIQWIRD to docket FDA-2019-D-3324.
$6.5 Million Settlement Reached on Eve of Trial in Class Action Lawsuit Against Chipotle Over the Meaning of “Non-GMO”
Chipotle Wraps Up False Ad Suit With $6.5M Settlement (subscription to Law360 required)
- As previously covered on this blog, a plaintiffs’ class action lawsuit was filed against Chipotle in the “Food Court” (Northern District of California) in connection with the chain’s nationwide advertising campaign premised on a pledge to serve only “non-GMO” foods. On October 1, 2018, the court certified three classes of consumers, in California, Maryland, and New York, who claim to have purchased food at Chipotle advertised as “non-GMO,” but which contained meat and dairy ingredients from animals that had consumed genetically modified (GM) feed. The issue is whether reasonable consumers would have been deceived by such advertising.
- On September 11, 2019, just days before the scheduled trial date of September 16, 2019, the plaintiffs asked the court to approve a deal in which Chipotle has agreed to pay $6.5 million to settle the false advertising claims. As part of the settlement, the three classes, in California, Maryland, and New York, would be consolidated into a single class consisting of all U.S. residents who purchased Chipotle food during the class period from April 27, 2015 to June 30, 2016. Class members would receive refunds of $2 per meal for up to 5 meals without documentation and up to 10 meals with documentation, for a total limit of 15 meals per household. The four class representatives would receive $5,000 each. The attorneys would receive fees of $1.96 million and out-of-pocket expenses of up to $650,000.
- While Chipotle has discontinued the advertising at issue, the debate over the meaning of “non-GMO” is certain to continue. As discussed here, the Non-GMO Project sponsors labels certifying adherence to standards that define the meaning of “non-GMO,” which would clear up the potential for consumer misunderstanding of the scope of the “non-GMO” claim, as was at issue in the Chipotle lawsuit. However, according to a Citizen Petition to the Food and Drug Administration (FDA) dated September 24, 2018 by the Information Technology & Innovation Foundation (ITIF), even a “non-GMO” label that is clear on the scope of the claim may mislead and deceive consumers about non-existent differences in health and safety of the labeled food and should, therefore, be prohibited. FDA has not yet taken substantive action on the Citizen Petition and is unlikely to do so in the near future.
FDA Will Seek to Remove Flavored E-Cigarettes from the Market
- On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy to prioritize enforcement of the premarket authorization requirements against non-tobacco flavored e-cigarettes. E-cigarettes on the market as of August 8, 2016, the effective date of FDA’s “Deeming Rule”, are currently allowed to be marketed until Premarket Tobacco Product Applications (PMTAs) are due – the deadline for which has shifted numerous times over the years, and is currently set for May 11, 2020. See American Academy of Pediatrics v. FDA.
- Prior to the American Academy of Pediatrics decision, in March 2019 FDA had published a draft guidance that proposed to modify the compliance policy and accelerate the PMTA deadline for certain flavored products. Specifically, that draft guidance proposed to move the PMTA deadline for most flavored e-cigarettes from August 2022 to August 2021, and to eliminate the compliance policy entirely (immediately enforcing PMTA requirements) for any flavored e-cigarette (but not tobacco, menthol or mint) that are marketed toward youth (e.g., youth-appealing packaging, branding, social media) or sold in non-adult only retail locations. See our blog post summarizing this here.
- The shift to potentially eliminating the compliance policy entirely for all flavored e-cigarettes (including mint and menthol flavors) follows a tumultuous few weeks for the vapor industry. The FDA and CDC are currently investigated 380 “vape related” lung illnesses, including several tragic deaths. FDA has indicated, however, that these appear to be the result of certain thickening agents (e.g., vitamin E acetate) used in illicit THC and marijuana oil vaporizers, not nicotine e-liquids. See FDA’s website on Lung Illnesses Associated with Use of Vaping Products here. Earlier this month, Michigan Governor Gretchen Whitmer announced that the Michigan Department of Health and Human Services would be promulgating emergency rules to ban the sale of all flavored e-cigarettes in the state. And FDA has now released preliminary results from the 2019 National Youth Tobacco Survey (NYTS) which appear to demonstrate both an increase in flavored e-cigarette experimentation (i.e., past 30-day ever use) among teenagers, but also a significant decrease in traditional cigarette smoking – which is at historic lows among youth in the U.S.
- We will continue to follow this policy development and, as FDA provides more insight into its policy, we will provide updates in this blog or on www.thecontinuumofrisk.com, the Keller and Heckman tobacco and e-vapor blog.
FTC Steps Up Enforcement Against CBD Health Claims
- CBD-infused products continue to flood the market as the U.S. Food and Drug Administration (FDA) explores additional regulatory pathways for hemp products containing cannabidiol (CBD). Currently, under the Federal Food, Drug and Cosmetic Act, CBD cannot lawfully be added to a food or marketed as a dietary supplement.
- On September 10, 2019, the Federal Trade Commission (FTC) sent warning letters to three unnamed companies that sell oils, tinctures, capsules, “gummies,” and creams containing CBD. The FTC said the three companies advertised that their CBD products treated or cured serious diseases and health conditions. For example, one company’s website claims CBD “works like magic” to relieve “even the most agonizing pain” better than prescription opioid painkillers. The letters warn the companies that it is illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims.
- Earlier in March 2019, the FTC and FDA sent similar warning letters to three companies. According to those advertisements, the products can effectively treat diseases, including cancer, Alzheimer’s disease, fibromyalgia, and “neuropsychiatric disorders.” Moving forward, expect both the FTC and FDA to continue using their enforcement authority to ensure that CBD-containing products are advertised truthfully.
Coconut Industry Campaigns to Remove Coconuts from “Top 8” Allergen List
- On September 10, the Coconut Coalition of the Americas (CCA) launched a campaign to remove coconuts from the “top 8 allergen” list. As our readers likely know, the Food Allergen Labeling Consumer Protection Act (FALCPA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require the labeling of foods that contain the eight most common food allergens or ingredients derived from them. The eight most common allergens are: (1) milk; (2) eggs; (3) fish (e.g., bass, flounder, cod); (4) Crustacean shellfish (e.g., crab, lobster, shrimp); (5) tree nuts (e.g., almonds, pecans, walnuts); (6) wheat; (7) peanuts; and (8) soybeans. In guidance, FDA indicated coconuts are considered to be a “tree nut” and should therefore be declared by its common or usual name in a product’s allergen statement.
- As part of the campaign, CCA plans to submit a citizen petition to FDA requesting that FDA revise the FALCPA guidance and remove coconut from the list of “tree nuts” identified as a major food allergen. According to CCA, coconut is not a major food allergen nor is it a nut. CCA cites The American College of Allergy, Asthma and Immunology which states that “[c]oconut is not a botanical nut; it is classified as a fruit, even though the Food and Drug Administration recognizes coconut as a tree nut. While allergic reactions to coconut have been documented, most people who are allergic to tree nuts can safely eat coconut.” We note that the Food Allergy Research and Resource Program (FARRP) has stated some fruits are commonly considered to be nuts (e.g., coconut).
- In a press release provided by the association, CCA Executive Director Len Monheit asserted that “[t]he FDA misclassified coconut, which is causing confusion for a lot of people because it shouldn’t be classified with tree nuts. Consumers with a tree nut allergy, but not a coconut allergy, are being deprived of this fruit. And, industry is being greatly impacted as contract manufacturers wanting to use coconut have to unnecessarily classify their facility as a tree nut facility when they’re not.”
- As our readers may remember, in the fall of 2018, FDA announced that it is considering mandatory food labeling for sesame to help protect consumers with sesame allergies. However, FDA has not indicated any plans to reconsider whether coconut is a tree nut.
Mississippi Reverses Stance on Plant-Based Meat Labeling
- As previously reported on this blog, Upton’s Naturals Co. and the Plant Based Foods Association (PBFA) filed a lawsuit challenging Mississippi’s law prohibiting cell-based, plant-based, or insect-based foods from being labeled as “meat” or a “meat food product” (i.e., “hamburgers,” “hotdogs,” etc.). The lawsuit was filed on July 1, 2019, the same day that the law took effect. The plaintiffs claimed that the Mississippi law violated their First Amendment right to free speech, among other things. The Institute for Justice (IJ) later joined the plaintiffs in the lawsuit.
- Last week, the Mississippi Department of Agriculture and Commerce proposed new regulations to implement the law that would allow the use of meat and meat product terms on the labels of plant-based food if certain conditions are met. More specifically, the proposed regulations specify that a plant-based food product will not be considered to be labeled as a “meat” or “meat food product” if one or more of the following terms, or a comparable qualifier, is prominently displayed on the front of the package: “meat free,” “meatless,” “plant-based,” “veggie-based,” “made from plants,” “vegetarian,” or “vegan.”
- After the proposed regulations were revised, Ag Commissioner Andy Gipson issued a statement on September 6, stated that the law “is constitutional and has not changed.” He added, “Our proposed rules support the law and make it clear these products cannot be false or misleading and cannot be labeled as meat or as a meat food product, but must use the qualifiers set out in the regulations.” He also claimed that there “was no need for a federal lawsuit.”
- Expressing an opposing view, IJ issued a press release stating that the recently proposed regulatory changes were in response to the lawsuit. “Our lawsuit made it clear that subjecting plant-based food companies to possible criminal prosecution for using common terms on their labels would be a violation of their free speech rights,” said IJ Senior Attorney Justin Pearson.
- Upton’s Natural and PBFA will consider dropping their federal lawsuit if the proposed regulations are adopted after the 25-day public comment period, according to the press release. We will continue to monitor and report on legal and regulatory activity in this area.
New Study Finds Soft Drink Consumption Associated with Overall Increased Risk of Death
- The Journal of the American Medical Association (JAMA) on September 3, 2019 published a new population-based cohort study of 451,743 individuals from 10 countries in Europe that found consumption of two or more servings per day of soft drinks was associated with a higher risk of all-cause mortality. The authors referenced previous studies showing an association between consumption of soft drinks – both sugar sweetened and artificially sweetened – with obesity, type 2 diabetes, and cardiovascular disease.
- The recent JAMA study found differences in the types of health effects for soft drinks, with consumption of artificially sweetened soft drinks being positively associated with deaths from circulatory diseases, and consumption of sugar-sweetened soft drinks being associated with deaths from digestive diseases (affecting the liver, appendix, pancreas, and intestines). The JAMA article also reports an association of soft drink consumption with Parkinson disease mortality but recommends additional studies to examine the association. The JAMA study found no association between soft drink consumption and death from cancer or Alzheimer’s disease.
- The baseline for comparison of risk of death from consumption of two or more soft drinks per day in the JAMA study was people who drank less than one glass of soft drink per month. Further, the study authors acknowledge that an observational study cannot establish causality, meaning that there may be some factor besides differences in soft drink consumption that is responsible in full or in part for the different mortality outcomes found in the JAMA study.
[update] The International Sweeteners Association (ISA) issued a statement providing more detailed concerns about the JAMA study methodology and its conclusions. Click here for more information.
