FDA Proposes New Graphic Warnings for Cigarettes

  • The Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by Section 201 of the Family Smoking Prevention and Tobacco Control Act (TCA; signed into law on June 22, 2009) directs the U.S. Food and Drug Administration (FDA) to develop graphic warnings for cigarette packages and promulgate regulations requiring the warnings within 24 months of enactment of the TCA.  Accordingly, FDA issued a final rule requiring graphic warnings on June 22, 2011. However, the original graphic warning images did not survive a First Amendment challenge by the tobacco industry (see R.J. Reynolds Tobacco Co. v. FDA), and FDA withdrew the rule.
  • In response to a lawsuit filed against FDA by a coalition of public health groups lead by The Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Heart Association and others, the U.S. District Court for the District of Massachusetts ruled that FDA “unlawfully withheld” or “unreasonably delayed” a revised graphic warning rule because nearly a decade had passed since the TCA was enacted. In March 2019, the Court ordered FDA to publish the new proposed rule by August 2019 and issue a final rule in March 2020.  FDA promulgated a notice of proposed rulemaking on the new cigarette health warnings on August 15, 2019 (available here).
  • The proposed rule would require advertising and packages of cigarettes sold in the United States to include one of thirteen warnings:
    • WARNING: Tobacco smoke can harm your children.
    • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
    • WARNING: Smoking causes head and neck cancer.
    • WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
    • WARNING: Smoking during pregnancy stunts fetal growth.
    • WARNING: Smoking can cause heart disease and strokes by clogging arteries.
    • WARNING: Smoking causes COPD, a lung disease that can be fatal. (This statement is paired with two different images.)
    • WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
    • WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
    • WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
    • WARNING: Smoking causes age-related macular degeneration, which can lead to blindness.
    • WARNING: Smoking causes cataracts, which can lead to blindness.
  • Under the proposal, each statement is paired with a graphic image, except the COPD statement which is paired with two different images.  The proposed labels, with the accompanying graphic images, can be found here.  Among other requirements, the top fifty percent (50%) of the front and rear panels of the package and 20% of the top of the advertisement would need to provide a graphic warning.
  • For more information, see FDA’s press release, landing page for Cigarette Health Warnings, and Web Feature.  Keller and Heckman attorneys in the Tobacco and E-Vapor Practice would be happy to assist those wishing to submit comments before the October 15 deadline for comments or with questions regarding the regulation of tobacco or e-vapor products.

EPA Refuses to Approve Glyphosate Labels with Proposition 65 Cancer Warning

  • In a direct rebuke of Proposition 65’s listing of glyphosate as a carcinogen, the US Environmental Protection Agency (EPA) issued a press release on August 8, 2019 announcing that it would no longer approve glyphosate labels with the Proposition 65 warning for cancer.  EPA Administrator Andrew Wheeler is quoted in the press release as stating, “It is irresponsible to require labels on products that are inaccurate when EPA knows the product does not pose a cancer risk.  We will not allow California’s flawed program to dictate federal policy.”
  • On August 12, 2019, the California agency that administers Proposition 65, the Office of Environmental Health Hazards Assessment (OEHHA), released a statement responding to EPA’s press release, highlighting that glyphosate was added to Proposition 65 based on findings by the World Health Organization’s International Agency for Research on Cancer (IARC).  OEHHA stated, “It is disrespectful of the scientific process for US EPA to categorically dismiss any warnings based on IARC’s determinations as false.”
  • The exchange between EPA and OEHHA is the latest chapter in the ongoing controversy concerning the safety of glyphosate, which was listed as a carcinogen under Proposition 65 in 2017, subject to a safe harbor level of 1,100 micrograms per day.  It is unclear how EPA’s announcement will impact Proposition 65 liability for glyphosate in California.

FDA Issues First Warning Letter to Food Importer Under FSVP

  • On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP).  As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP compliance date began May 30, 2017, however there are a range of compliance dates according to a number of considerations.
  • The warning letter, dated July 30, was issued to Brodt Zenatti Holdings LLC in Jupiter, Florida who imported tahini from the Israel-based manufacturer, Karawan Tahini and Halva. In May, the tahini was implicated in a Salmonella outbreak and was voluntarily recalled. In response to the Salmonella outbreak, FDA conducted an FSVP facility inspection, and found that the importer was in significant violation of the FSVP rule. As discussed in the warning letter, the importer did not develop an FSVP for the tahini as required by section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L. Within 15 working days, FDA has requested a response to the warning letter that demonstrates plans to correct or evidence that they have corrected the violations. Should the importer fail to correct the violations, they may be placed on the newly established Import Alert #99-41.
  • Since 2017, FDA has been conducting FSVP inspections in order to help importers understand the requirements and how to take corrective actions if deficiencies are observed. FDA will continue to take steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk. Additionally, as outlined in FDA’s Strategy for the Safety of Imported Food, FDA is committed to working with importers to come into compliance with all applicable FSMA regulations, including FSVP.  FDA’s Strategy is guided by four goals:
    • (1) Food offered for import meets US food safety requirements
    • (2) FDA border surveillance prevents entry of unsafe foods
    • (3) Rapid and effective response to unsafe imported food
    • (4) Effective and efficient food import program.

An overview of the Strategy can be found here.

Keller and Heckman attorneys are available to assist interested parties in preparing the necessary documentation for and navigating compliance under the FSVP rule. For assistance, please email: fooddrug@khlaw.com.

Hazelnut Crème Coffee False Advertising Lawsuit Revived

1st Circuit Gives Coffee Buyers 2nd Shot at False Ad Suit (subscription to Law360 required)

  • On August 8, 2019, the U.S. Court of Appeals for the First Circuit reversed a district court’s dismissal of a lawsuit charging that the label on New England Coffee’s Hazelnut Crème coffee violates Massachusetts’ consumer protection laws because the product does not contain hazelnuts. Kathy Dumont originally brought a putative class action against New England Coffee Company and Reily Foods Company (New England Coffee Company is a subsidiary of Reily Foods Company) in May 2018 in the U.S. District Court for the District of Massachusetts. U.S. District Judge Rya W. Zobel dismissed that case in September 2018.
  • In reversing the district court’s decision, Circuit Judge William J. Kayatta Jr., writing for the majority, stated that even though the ingredient list stated, “100% Arabica Coffee Naturally and Artificially Flavored,” the name of the product could be taken to imply the presence of hazelnuts. He also suggested that while a reasonable consumer who cared whether the coffee contained real hazelnuts would check the list of ingredients, “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, much like one might easily buy a hazelnut cake without studying the ingredients list to confirm that the cake actually contains some hazelnut.” (See Dumont v. Reily Foods and New England Coffee Company, U.S. Court of Appeals for the First Circuit, No. 18-2055.)
  • The Court of Appeals also found that Dumont’s claim under Massachusetts General Laws chapter 93A (concerning unfair and deceptive practice), was not impliedly preempted by federal law but did point out that the Federal Food, Drug, and Cosmetic Act will limit the scope of Dumont’s argument.
  • Judge Sandra Lynch wrote a dissenting opinion, stating, “…a reasonable consumer plainly could not view the phrase ‘Hazelnut Crème’ as announcing the presence of actual hazelnut in a bag of coffee which also proclaims it is ‘100% Arabica Coffee’.”

FDA is Asked to Approve Vitamin D3 For Use as a Nutrient Supplement in Grain-Based Nutrition Bars and at Higher Levels Than Currently Affirmed as GRAS in Breakfast Cereals

  • As a vitamin that is assigned a Reference Daily Intake (RDI) in 21 C.F.R. § 101.9(c)(8)(iv), vitamin D is an “essential nutrient.”  Vitamin D without a subscript represents either vitamin D2 or vitamin D3, which are the two major physiologically relevant forms of vitamin D.  Vitamin D is affirmed as generally recognized as safe (GRAS) for use as a nutrient supplement in certain foods at the specified maximum levels in 21 C.F.R. § 184.90.  The Food and Drug Administration (FDA) permits the fortification of some other types of foods with vitamin D under 21 C.F.R. § 172.380 (“Vitamin D3”).
  • On August 12, 2019, FDA announced the filing of a food additive petition (FAP 9A4823) submitted by Kellogg Company to amend Section 172.380 to provide for the safe use of vitamin D3 as a nutrient supplement in breakfast cereals and grain-based nutrition bars (e.g., granola bars).  While no additional information is available in the relevant Docket No. FDA-2019-F-3519, the FAP presumably requests fortification of breakfast cereals with vitamin D3 at a level greater than 350 International Units (IU) per 100 grams as is currently permitted under the GRAS regulation for vitamin D.  There is no current GRAS regulation or food additive clearance for the use of vitamin D as a nutrient supplement in nutrient bars.  Unlike breakfast cereals, nutrient bars are not among the categories of food that are defined in 21 C.F.R. § 170.3(n), but nutrient bars has been identified as a category for the purpose of determining intake of food ingredients in several GRAS notices.
  • FDA may approve the use of a food additive only after conducting a scientific review to ensure safety by comparing the estimated daily intake (EDI) of the additive from the proposed use and all food sources to an acceptable intake level established by toxicological data.  In a 2014 amendment of Section 172.380 to permit the use of vitamin D3 as a nutrient supplement in certain meal replacement beverages, FDA adopted the upper limits (ULs) for vitamin D established for various age groups by the Institute of Medicine (IOM) as the highest average daily intake levels that poses no risk of adverse effects when consumed over long periods of time.  We expect that FDA will apply the same framework for reviewing Kellogg’s petition and, therefore, barring any new toxicological data, the proposed new use of vitamin D3 in breakfast cereals and nutrition bars must not cause the EDI for vitamin D to exceed the relevant levels for various age groups in the range of IOM ULs for vitamin D for the U.S. population 1 year of age and older of 2,500 IU/person/day to 4,000 IU/person/day.

FSVP Follow-up

  • With little fanfare, FDA issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification Program (FSVP) Regulation.  The FSVP regulations require importers to evaluate and document their suppliers and the steps taken to ensure the safety of food being imported.  Each food item being imported must have its own FSVP review.
  • An Import Alert is guidance within the Food and Drug Administration (FDA) that certain shipments into the United States should be held until the importer proactively demonstrates compliance with the law.  Additionally, Import Alerts generally explain the problem and provide guidance to FDA field staff on how to uniformly describe the problem in paperwork.  The Import Alert will often have a green list (as an exception to a general rule to prevent products from coming in), a yellow list (to identify entities that are known to be working towards compliance but whose products are still to be detained), or a red list (the specific entities whose products will be detained) of entities.  For example, IA 45-02, for detention of foods containing illegal and undeclared colors has both a green and red list and IA 22-01 for detention of cantaloupes from Mexico has both a green and yellow list.
    • The import alert for FSVP violations directs field staff to consult the red list but, thus far, the red list is empty.  This implies that FDA expects to use the import alert process as a means of targeting importers who do not comply with their regulatory obligations for FSVP.
  • Of interest, the beginning of produce safety inspections, addressed in yesterday’s Daily Intake Blog post, is important not just for produce operations – FDA has previously indicated that it will begin FSVP inspections of importers of produce from large farms “in Fall 2019” which would allow for these inspections to begin “approximately six months after FDA begins routine inspections of those large farms under the Produce Safety rule.”  It may be that the FSVP inspections of imports of produce from large farms will result in the first additions to the red list for IA 99-41.  Given FDA’s policy of using initial FSVP inspections to educate, we might expect the first entrants on the red list to be importers who have already undergone FSVP inspections.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about compliance with FSVP, responding to FDA correspondence regarding an FSVP inspection, or about clearing products listed on an import alert so as to allow imports into the country to proceed.

Inspections Begin Under FDA’s Produce Safety Rule

  • As our readers may know, the FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here.
  • The compliance dates for the Produce Safety Rule depend on the size of the farm and can be found here. While compliance was set to begin on January 26, 2018 for large farms, other than sprouts operations, FDA announced its decision to postpone routine inspections until the spring of 2019. Routine inspections of small farms, other than sprouts operations, are set to begin in spring 2020. Through FDA funding, several states have developed produce safety programs, which include inspection and enforcement programs; for those states, the respective state agriculture departments will conduct compliance inspections.
  • As reported here, both states’ departments of agriculture and FDA have already started or are planning to begin visits soon to produce farms to conduct inspections for compliance with the Produce Safety Rule. Keller and Heckman attorneys are available to assist interested parties in preparing for and navigating compliance inspections under the Produce Safety Rule. For assistance, please email: fooddrug@khlaw.com.

New Study Finds Prevalence of Sesame Allergy, as Illinois Becomes First State to Mandate Sesame Labeling on Packaged Foods

  • A new study by researchers from Northwestern University found that 0.49% of Americans, or 1.5 million children and adults, reported having an allergy to sesame, based on responses to a national survey of over 50,000 households. The results of the study indicate that there may be more Americans with a sesame allergy than there are people allergic to tree nuts, like pine and macadamia nuts. More than a decade ago, similar research reported that only 0.1% of consumers had a sesame allergy.
  • The results of the study come almost a year after the FDA announced that it would consider adding sesame to the list of major allergens required to be labeled. As required by the Food Allergen Labeling Consumer Protection Act (FALCPA), federal law provides that foods containing one of the eight “major food allergens” – milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans – must declare the food source of the allergen using its common or usual name on food labels. In light of new evidence that sesame allergies may be a growing concern, FDA issued a request for information in October 2018 “to learn more about the prevalence and severity of sesame allergies in the US.” Comments were due December 31, 2018. However, FDA has yet to take further action.
  • Sesame allergen labeling is already required in the European Union, Canada, Australia, and New Zealand. Illinois is the first US state to mandate sesame labeling. In February, Illinois State Representative Jonathan Carroll introduced HB 2123 as a result of his daughter’s own sesame allergy. HB 2123 was signed into law as Public Act 101-0129 by Illinois Governor J.B. Pritzker on July 26, 2019. The law mandates that food manufacturers of packaged foods indicate the presence of sesame on the labels as they would for the federally mandated “top 8” allergens. It seems the Illinois law is intended to encourage FDA to require sesame to be labeled as an allergen. Indeed, Rep. Carroll has stated he wants Illinois’ action to spark a national trend: “I hope that the FDA and other states will follow suit.” However, since FALCPA is preemptive, meaning that other governmental agencies may not adopt labeling requirements that differ from FALCPA, the Illinois law is likely preempted.

 

Congress Continues Efforts to Combat Food Waste

  • As previously reported on this blog, food waste is a major issue in the United States. We also have reported on previous attempts by Congress to curb food waste through legislation (see here and here). The most recent effort to reduce food waste was made by Representatives Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.) when they re-introduced the Food Date Labeling Act, H.R. 3981 on July 25, 2019. The legislation is designed to end consumer confusion by creating a national standard for date marking of food. Currently, there are no federal regulations related to date labels on foods products other than for infant formula.
  • The national date labeling standard under the Food Date Labeling Act would allow food manufacturers to use either a quality date or a discard date.
    • “BEST If Used By” would let consumers know that the quality of the food product may begin to deteriorate after the date provided.
    • “USE By” would indicate the end of the estimated shelf life, after which the product should not be consumed.
  • Noting that 90% of American prematurely throw out safe food while 38.4 million Americans are food insecure, Rep. Pingree, stated in a press release that this bill can help ensure that “food is being used and eaten, rather than thrown out due to confusion.” The bill also allows food to be sold or donated after the quality-based date.
  • The Food Date Labeling Act was referred to the Committee on Energy and Commerce and the Committee on Agriculture. On July 30, Senator Richard Blumenthal (D-Conn.) introduced a companion bill in the Senate, S 2337, which was referred to the Committee on Health, Education, Labor, and Pensions.
  • FDA addressed this issue a few months ago in a May 23, 2019 letter to food companies, in which the Agency endorsed the voluntary use of the “Best If Used By” label for food. The letter also pointed out that while industry has recommended the phrase “Use By” to apply to perishable products that should be consumed by the date on the package, FDA was not addressing the use of a “Use by” product date label for safety reasons at that time. (See our May 24 blog.)

USDA Testimony Sparks Debate Over Allowing Gene Editing for Food Labeled as Organic

  • The National Organic Program (NOP) of the U.S. Department of Agriculture (USDA) works with the National Organic Standards Board (NOSB) to develop standards involving the production, handling, and processing of ingredients that may be used in products bearing the label “USDA organic.”  Under the current requirements for organic labeling, genetic engineering is a prohibited method and there is no apparent exception for newer technologies which bioengineering (BE) proponents have contrasted with older, less precise BE methods that organic advocates criticize for human health and environmental concerns.
  • In a July 17, 2019 hearing of the House Agriculture Subcommittee on new gene editing technology, testimony by Greg Ibach, USDA’s Under Secretary for Marketing and Regulatory Programs (MRP), noted the benefits of insect and drought resistance and increased yield and included a remark that USDA “may be ready to open discussion to consider whether it is appropriate” to consider allowing certain gene editing technology for use in organic production.  Responding to this testimony, the Cornucopia Institute has released a petition strongly opposing such developments.
  • As it stands, USDA’s bioengineered (BE) food labeling rule does not establish whether gene edited products fall under the definition of “bioengineered” and, thus, whether these products will require mandatory disclosure.  Thus, it is possible that USDA may decide not to require BE labeling for products produced using certain gene editing technology and could also someday permit products containing ingredients made with this technology to bear the USDA organic label.  Such development could further confuse consumers interested in avoiding bioengineered food and may also potentially impact the credibility and monetary value of the USDA organic label.  As we have reported, there is already evidence that some consumers may not distinguish between the “USDA organic” label and the “Non-GMO Project Verified” seal administered by the Non-GMO Project that is available for products meeting the group’s criteria for certification as being free of genetically modified organisms (GMOs), although sales of products labeled by the Non-GMO Project more than doubled from 2014 to 2016, whereas the sales of organic foods have increased at a much slower rate.
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