More States Ban Plastic Grocery Bags

  • During the past month, the governors of Vermont, Maine, Oregon, Delaware and Connecticut signed legislation banning single-use plastic bags and a few months earlier, on April 22, New York’s governor signed similar legislation.
  • New York’s plastic bag ban is scheduled to take effect on March 1, 2020. The law bans most single-use plastic carry-out bags provided by grocery and other stores unless they are exempted. Exemptions include bags used to wrap uncooked meat, fish or poultry; bags to hold food prepared to order; bags used by a customer for bulk items (e.g., fruits and vegetables); bags for carryout or delivered food; and food storage bags. The legislation also allows individual counties to charge five cents for paper bags.
  • Maine’s H.P. 1115 (LD 1352) bans retail establishments from providing customers with most single-use plastic bags, effective January 1, 2020. The legislation lists a number of exemptions, such as bags for prescription medication, bags for use within a store to package loose items, and dry-cleaning bags. Retail establishments may provide a recycled paper bag of reusable plastic bag for a fee of at least five cents per bag.
  • Oregon’s HB 2509 bans retail establishments and restaurants from providing customers single-use checkout bags. Certain bags are exempted, such as bags for produce, meat, fish and dry cleaning. Stores may provide paper checkout bags, reusable fabric checkout bags, or reusable plastic checkout bags for at least five cents each. The ban becomes effective in January 2020.
  • Vermont’s Act No. 69 (S.113) prohibits stores and food establishments from providing single-use plastic bags, effective July 1, 2020. Pharmacy bags for prescription medication; bags used inside a store to package loose items, frozen foods, meat, fish or flowers; and dry-cleaning bags are exempted. The legislation also prohibits food service establishments from providing single-use plastic straws unless requested and bans the sale of expanded polystyrene food service products.
  • Delaware’s HB 130 bans bags that are “made from non-compostable plastic and not specifically designed and manufactured to be reusable” effective January 1, 2021. Exceptions include plastic bags to wrap damp items like frozen foods, bags to transport chemicals, and dry-cleaning bags.
  • Single-use plastic grocery bag are currently banned in California and Hawaii. California has had a statewide plastic bag ban in place since late 2016 and, plastic grocery bags are banned in all counties in Hawaii.

Upcoming Public Workshop to Provide Update on FDA’s Predictive Toxicology Roadmap

  • Adequate toxicological data – often involving the sacrifice of laboratory animals – are necessary for reaching a safety decision on the products that are subject to FDA’s regulatory review.  FDA’s Predictive Toxicology Roadmap, published in December 2017, is a six-part framework for integrating predictive toxicology methods into the Agency’s safety and risk assessments.  FDA’s initial public workshop on the Roadmap, held September 12, 2018, covered human tissue on a computer chip and other  new technologies already used in industry that support animal 3Rs (Replacement, Reduction, and Refinement).  FDA also highlighted new and revised guidance documents that have incorporated some of the new toxicology approaches.
  • On Wednesday, September 18, 2019, FDA will host another public workshop, Implementing FDA’s Predictive Toxicology Roadmap: An Update of FDA’s Activities, to highlight recent work.  While much of the new technology is being developed with a focus on drug screening and toxicity testing, a number of predictive modeling approaches may also be applicable to other FDA-regulated industries such as food and tobacco products.  For example, the agenda for the 2019 Roadmap workshop features experts from FDA’s Center for Food Safety and Applied Nutrition (CFSAN) speaking on topics including Tox21, EU ToxRisk, and FDA’s application of an expanded decision tree and the threshold of toxicological concern (TTC) approach for safety assessment.
  • Interested parties may attend the Roadmap workshop in person or via Adobe Connect.  Attendees must register by Monday, September 16, 2019.

 

Mississippi Sued Over Plant-Based, Cell-Based, and Insect-Based Meat Labeling Law

  • Like countless other states, earlier this year, Mississippi passed SB 2922, which stipulates that cell-based, plant-based, or insect-based foods cannot be labeled as “meat” or “a meat food product” (e.g., “hamburgers,” “hot dogs,” “sausages,” “jerky”, etc.). Specifically, SB 2922 amended Section 75-35-15(4) of the Mississippi Code to state “[a] food product that contains cultured animal tissue produced from animal cell cultures outside of the organism from which it is derived shall not be labeled as meat or a meat food product. A plant-based or insect-based food product shall not be labeled as meat or a meat food-product.” Such products still run afoul of the law even if the labels include claims like “100% vegan,” “plant-based,” or “meatless.”
  • SB 2922 came into effect on July 1, 2019. On that same day, vegan “meat” producer, Upton’s Naturals Co. and the Plant Based Foods Association (PBFA) filed suit in federal court against Mississippi’s Governor and Commissioner of the Department of Agriculture and Commerce arguing that the label restrictions violate their First Amendment right to free speech, among other claims. Upton’s and PBFA are seeking a declaratory judgment that SB 2922 violates the First and Fourteenth Amendments to the U.S. Constitution, a preliminary injunction prohibiting enforcement of SB 2922 throughout the duration of the litigation, a permanent injunction, and an award of nominal damages in the amount of $1.00.
  • Mississippi’s Department of Agriculture and Commerce, along with the state’s cattle and poultry associations, supported the state law. Indeed, in response to the lawsuit, the Department said it has a “duty and obligation to enforce the law” and that it wanted to ensure the consumer has “clear information on the meat and non-meat products they purchase.” However, supporters of the lawsuit, like the Good Food Institute, argued that “Mississippi is acting as word police” and that the law is a “slippery slope” that could open the door to restrictive labeling.

 

The Daily Intake is taking a break for the Fourth of July holiday and will return on July 8, 2019.  We wish you a wonderful Fourth of July holiday! 

Bill Introduced to Protect State Cannabis Programs from Federal Interference

  • As previously reported on this blog, while the 2018 Farm Bill removed hemp from the Controlled Substances Act, its passage did not affect FDA’s authority to regulate cannabidiol (CBD) or other hemp products in FDA-regulated products. In December 2018, FDA released a statement clarifying that it is illegal to sell a food or dietary supplement that contains added CBD or THC in interstate commerce. Five months later, during a public hearing on products containing cannabis or cannabis-derived compounds, Acting FDA Commissioner Ned Sharpless, MD, reiterated that under current federal law, CBD cannot lawfully be added to a food or marketed as a dietary supplement. He also expressed concern about the lack of research to support CBD’s use in FDA-regulated products. (See our June 4, 2019 blog for more details.)
  • On June 27, 2019, U.S. Senator Ron Wyden (D-OR) and U.S. Representative Earl Blumenauer (OR-03) introduced the State Cannabis Commerce Act, which would permanently protect all state cannabis programs from federal interference and allow for interstate cannabis commerce between states. The legislators point out in a press release that since 2014, “federal law has prohibited the Department of Justice (DOJ) from using taxpayer funds to prevent states from implementing their own state laws that authorize the use, distribution, possession or cultivation of medical marijuana.” The State Cannabis Commerce Act would expand that law to include all cannabis producers or consumers who transport cannabis between states that have legal cannabis programs and where the states agree to the transportation.
  • Concerning the bill, Sen. Wyden stated: “As more and more states legalize cannabis, the gap between state and federal laws will only grow more confusing for both legal businesses and consumers. He added that, “the federal government needs to end its senseless and out of touch prohibition.”
  • Two days prior to issuing the legislation, on June 25, Sen. Wyden urged FDA in a letter to “immediately issue enforcement discretion guidance not later than August 1, 2019…to ensure a regulatory pathway for lawful use of CBD in a food additive and as a dietary ingredient in a dietary supplement.” However, as previously reported on this blog, FDA’s Principal Associate Commissioner for Policy, Dr. Amy Abernethy, reiterated in a June 14 2019 statement that outstanding questions related to the safety of CBD products must be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD. Responses to FDA’s request for information on safety (including whether there is a threshold level that could appropriately be considered safe), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds are due by July 16, 2019 (See docket, FDA-2019-N-1482).

Plaintiffs Cling to Slim Chance of Success in 9th Circuit After 2nd Circuit Affirms the Term “Diet” is Not False and Misleading in Name of Soft Drink Sweetened with Aspartame

 2nd Circ. Cans Diet Coke Drinkers’ False Ad Suit (Subscription to Law360 required)

  • The U.S. Court of Appeals for the 2nd Circuit dismissed the plaintiffs’ lawsuit in Geffner v. The Coca Cola Company, Case No. 18-16721, Decided: June 27, 2019 over claims that the “diet” labeling in Diet Coke is false and misleading.  The panel affirmed its decisions earlier this year in similar lawsuits involving Diet Pepsi and Diet Dr Pepper that, in the context of soft drinks, the term “diet” refers to calorie content, and it has no absolute meaning, such that in order to meet federal advertising standards, a diet soft drink need only have fewer calories than its non-diet version.
  • Plaintiffs in diet soda lawsuits do not dispute that soft drinks sweetened with aspartame have fewer calories than their non-diet counterparts but contend that the word “diet” on such labels is nevertheless misleading because consumers reasonably believe the drinks will help with weight loss and drinks  containing aspartame instead contribute to weight gain.  The law firm representing the plaintiffs in Geffner has indicated they will pursue this argument in similar claims involving Diet Dr Pepper on behalf of other plaintiffs in the 9th Circuit.
  • As we have previously reported, the Federal District Court for the Northern District of California has repeatedly dismissed false advertising claims against Diet Dr Pepper, stating in its dismissal of the plaintiffs’ third amended complaint that new studies “still fail to offer a single finding of causation between aspartame or diet soda products and weight gain…correlation is not causation, neither for purposes of science nor the law.”  We are not aware of new scientific data that would make a fourth amended complaint any more likely to succeed.

 

FDA Adds New Ingredients to Dietary Supplement Ingredient Advisory List

  • On June 25, Frank Yiannis, Deputy Commissioner, Food Policy and Response, Food and Drug Administration (FDA), announced via Twitter that FDA has added octopamine and N-Methyltyramine to the Dietary Supplement Ingredient Advisory List (the “List”).  Inclusion in the list indicates that FDA believes that the ingredient may not be legally marketed based on a preliminary evaluation though not necessarily that the ingredient is unsafe.  FDA urges consumers to avoid using dietary supplements containing ingredients on the list and retailers, manufacturers, and other businesses to avoid selling, making, or distributing dietary supplements containing these ingredients.
  • Though not added at the time of writing, additional details on FDA’s rationale for inclusion on the list will be included via hyperlink at FDA’s Dietary Supplement Products & Ingredients website.  For example, the 1 ,3-dimethylamylamine (DMAA) page describes DMAA, explains that FDA does not view it as a dietary ingredient because it does not exist naturally, discusses safety of the product, enumerates FDA’s efforts to remove products containing DMAA, and advises consumers to avoid DMAA and take steps if being harmed by consumption of DMAA containing supplements.
  • The List was introduced on April 16 as a means of protecting consumers as part of a plan for modernizing and strengthening dietary supplement oversight.  This is part of a broad effort to modernize food regulation, including the Agency’s Nutrition Innovation Strategy and goal of modernizing Standards of Identity.

San Francisco Passes Law Ban on E-Cigarettes Sales

  • On Tuesday, June 25th, San Francisco’s City’s Board of Supervisors voted unanimously in favor of an ordinance to effectively ban e-cigarette sales in the city. As previously reported on this blog, the measure was initially announced in March of this year, with City Attorney Dennis Herrera noting in a statement that “FDA has failed to do its job when it comes to e-cigarettes. Until the FDA does so, San Francisco has to step up.”
  • The ordinance prohibits the sale by tobacco retail establishments of e-cigarettes and the sale and distribution to any person in San Francisco of flavored tobacco products and e-cigarettes that “require, but have not received, an order from the [FDA] approving their marketing.” Notably, the San Francisco ban does not extend to non-flavored combustible cigarettes, which are grandfathered and exempt from FDA premarket review if they were on the market as of February 15, 2007, pursuant to the Tobacco Control Act.
  • To date, no e-cigarettes have received Premarket Tobacco Product Application (PMTA) authorization from FDA, in large part because FDA’s “Deeming Rule,” which extended the Agency’s tobacco authority to e-cigarettes, delayed the PMTA deadline for products on the market when the rule went into effect on August 8, 2016. The current PMTA deadline, however, remains in flux as a result of the May 15, 2019 decision from the U.S. District Court for the District of Maryland in American Academy of Pediatrics v. FDA, which vacated the original guidance document which had extended the premarket review compliance policy deadline for currently marketed e-cigarettes to August 8, 2022.
  • Following the vote, City Attorney Dennis Herrera said in a statement, “This is a decisive step to help prevent another generation of San Francisco children from becoming addicted to nicotine.” Once approved by Mayor London Breed, who has signaled her support of the measure, the ordinance becomes effective 30 days after signature and operative six months after the effective date.

 

 

 

FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products

  • On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies also made claims about treating pain, as well as other medical conditions like depression, anxiety, and cancer.
  • In FDA’s press release, Acting FDA Commissioner Ned Sharpless noted that there are no FDA-approved uses for kratom and the agency has been active in warning consumers about the serious risks associated with kratom. For example, as our readers may know, FDA has warned about both the high levels of heavy metals found in kratom products and the contamination of certain kratom products with salmonella. Indeed, FDA issued its first ever mandatory recall order for the salmonella-containing kratom products.
  • The June 25 warning letters allege that the companies used their websites and social media to illegally market kratom products and made unproven claims about the ability of the products to cure, treat, or prevent disease. Examples of the claims include:
    • “Kratom acts as a μ-opioid receptor-like morphine.”
    • “In fact many people use kratom to overcome opiate addiction.”
    • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
    • “Usage: It is for the management of chronic pain, as well as recreationally.”
  • FDA reiterates that “[t]hese products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.” FDA has requested responses from both companies within 15 working days.

FDA Issues Draft Guidance on Reducing Microbial Hazards in Seed for Sprouting

  • The U.S. Food and Drug Administration (FDA) has issued a draft guidance, titled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.” This draft guidance document provides food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting.
  • FDA reported that between January 1996 and August 2018, contaminated sprouts were associated with 50 outbreaks, which resulted in more than 2,600 cases of foodborne illness. In the Federal Register notice about the draft guidance, FDA explains that the document “will make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of FDA’s serious concern with the continuing outbreaks of food borne illness associated with the consumption of raw and lightly-cooked sprouts…”
  • The Produce Safety Rule, as required by the FDA Food Safety Modernization Act (FSMA), includes sprout-specific requirements. (Keller and Heckman’s detailed summary of the rule is available here.) However, since FDA considers seeds used for sprouting to be outside the definition of “covered produce” under the rule, the Agency did not prescribe specific requirements in the Produce Safety Rule to prevent the introduction of known or reasonably foreseeable hazards into or onto seed during growing, harvesting, conditioning, or holding of seed. The draft guidance includes steps that those in the sprout seed supply chain should take to reduce microbial food safety hazards, such as proper training of personnel, storing seed for sprouting separately from seed for other uses, and ensuring that food contact surfaces are cleaned regularly.
  • The draft guidance will be available for public comment for 60 days until August 26, 2019. Comments should be identified with the docket number FDA-2018-D-4534 and can be submitted electronically at https://www/regulations.gov.
  • Keller and Heckman attorneys and scientists are experienced with advising on FSMA, Produce Safety and sprout seed, and related regulatory issues, and would be happy to answer any questions.

FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food

 

  • The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by FDA under 21 C.F.R. Part 117 and Part 507, respectively.  Meeting the “small business” definition has two main implications: (1) Certain small businesses (i.e., “farm mixed-type facilities”) are exempt from the human and animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations, and (2) Small businesses have later compliance dates for parts 117 and 507.
  • As previously reported on this blog, FDA released draft guidance on March 19, 2018 for determining the number of employees for purposes of meeting the “small business” definition under parts 117 and 507.  Notably, some compliance dates applicable to small businesses have not yet passed, such as the September 18, 2019 and September 17, 2020 extended compliance dates for written assurances in the customer provisions in 21 C.F.R. §§ 117.136(a)(2)(ii), (3)(ii), and 4(ii) and 507.36(a)(2)(ii), (3)(ii), and 4(ii), respectively.
  • With a June 21, 2019 notice, FDA released its final guidance on determining the number of employees under the “small business” definition.  Having received no substantive comments on the March 2018 draft guidance, FDA made only editorial changes to improve clarity and revised one example to make it more useful.

 

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