• 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  • Prior to the American Academy of Pediatrics decision, in March 2019 FDA had published a draft guidance that proposed to modify the compliance policy and accelerate the PMTA deadline for certain flavored products.  Specifically, that draft guidance proposed to move the PMTA deadline for most flavored e-cigarettes from August 2022 to August 2021, and to eliminate the compliance policy entirely (immediately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.
  • 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.
  • 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.
  • 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.
  • 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.

 

For help in complying with regulatory requirement for food facilities please email us at fooddrug@khlaw.com.

  • FDA has announced that it is launching a new electronic submission system for New Dietary Ingredient Notifications (NDINs) on Friday, September 6.  The new system, the CFSAN Online Submission Module (COSM) is replacing the current FDA Unified Registration Listing System (FURLS). 
  •  NDINs are required to be submitted to FDA at least 75 days before marketing a dietary supplement with a new dietary ingredient.  However, FDA has lamented in its NDIN guidance that NDINs are not commonly submitted.  Approximately 1100 NDINs have been submitted since 1995.  The new system will also be used for structure/function claim notifications (SFCNs), which are required to be submitted to FDA no later than 30 days after the first marketing a dietary supplement that bears a structure/function claim. 
  •  FDA announced this initiative in a Federal Register notice in May 2019, noting that the Agency expects an increase in the average number of NDINs being submitted over the next three years.  For a preview of the COSM system, you can view screenshots on FDA’s website.

 

 

  • As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) have announced an agreement to share regulatory oversight over cell-based or cell-cultured meat. As part of the agreement, FDA will conduct premarket consultation to evaluate the manufacture of these products, including oversight of tissue collection, cell lines and banks, and all components of inputs.
  • The agencies have previously agreed that no additional legislation would be necessary to effectuate the joint agreement. No additional guidance or proposed regulations have been published by either FDA or USDA at this time.
  • In light of this regulatory uncertainty, five cell-based meat and seafood companies have formed a coalition to represent the industry. The coalition, Alliance for Meat, Poultry & Seafood Innovation (AMPS Innovation) includes five founding member companies, BlueNalu, Finless Foods, Fork & Goode, JUST, and Memphis Meats. These companies are currently in the research and development phase but expect to make products available in the next several years. In a joint statement, members noted the purpose of the coalition is to “speak with a unified voice as we emerge as a viable, impactful partner in the overall food and agriculture sector.”
  • USDA’s Food Safety and Inspection Service (FSIS) is responsible for monitoring the proper use and labeling of nitrates/nitrites by meat processors. Nitrate and/or nitrites have been historically used as synthetic curing agents to preserve fresh cut meats such as bacon. Meats are now more frequently prepared using celery powder and other non-synthetic sources of nitrates and nitrites which can produce similar antimicrobial properties, taste, and appearance to synthetic nitrates and nitrites. Nitrosamines are formed as a reaction from the use of nitrates/nitrites in meat which has been shown to be carcinogenic in animal studies.
  • For new processed meats that do not use synthetic nitrates/nitrites, FSIS requires the label to bear the term “Uncured” and the statement: “Uncured Bacon, No Nitrates or Nitrites Added” with the qualifier, “except for those naturally occurring in [name of ingredient that is source of nitrates/nitrites].”
  • In an August 29, 2019 petition submitted to FSIS, the Center for Science in the Public Interest and Consumer Report (the Petitioners) called on the Agency to stop requiring the terms “Uncured” and “No Nitrate or Nitrite Added” on labels for meat processed with nitrates or nitrites from non-synthetic sources, such as celery powder. The Petitioners cite recent tests that showed that nitrates and nitrites are found in processed meats labeled “Uncured” or “No Nitrates or Nitrites Added” at similar levels to those prepared with synthetic curing agents. As such, the Petitioners argue that those labels are misleading consumers to think meats with those claims are healthier and request that FSIS revise its rules so that the “Uncured” and “No Nitrate or Nitrite Added” claims can only be made on meats prepared with no nitrates or nitrites from any source. Additionally, the Petitioners request that all products processed using nitrates/nitrites bear the disclosure “Nitrates or nitrites added.”

Keller and Heckman attorneys are available to advise on the labeling of meat and poultry products in compliance with USDA labeling requirements.  For assistance, please email: fooddrug@khlaw.com.

  • FDA will hold a public meeting on September 27, 2019 to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity (SOI) and to provide information about changes the FDA could make to existing standards of identity.  Modernizing standards of identity is part of the agency’s Nutrition Innovation Strategy, with the agency first prioritizing the use of the term “milk” in labeling plant-based products.
  • The public will have a chance to discuss FDA’s effort to modernize food standards of identity and provide information about changes the agency could make to existing standards, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to facilitate innovation and provide flexibility for the development of healthier foods.  Three breakout sessions will address various topics, including: (1) nutrition topics: what changes to existing SOI would encourage production of more nutritious foods; (2) issues related to innovation and what horizontal approaches to modernization could better accommodate advances in science and technology; and (3) issues related to consumer expectations and standardized foods.
  • Written/electronic comments may be submitted beginning August 29, 2019. Persons interested in attending this public workshop either in-person or by web viewing must register online by September 20, 2019.