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  • Last month, phase 2 of Mexico’s front of pack (FOP) labeling regulations went into effect, triggering certain changes to the thresholds for FOP warnings.
  • We have previously reported on Official Mexican Standard NOM-051 which, among other things, requires FOP warnings when processed foods or non-alcoholic beverages exceed specific thresholds for calories, sugars, saturated fats, trans fats, and sodium. The changes are being implemented in three phases.
  • In phase 2, which runs from October 1, 2023, to September 30, 2025, the thresholds triggering FOP warnings for excess calories and excess sugars for liquid products, and excess sodium for solid products, have been made more stringent and changed to the following: 
    • Warning threshold for excess calories for liquid products: Greater than or equal to 70kcal total per 100mL of product or greater than or equal to 8kcal of added sugars per 100mL of product (previously the latter threshold was 10kcal of added sugar)
    • Warning threshold for excess sugars for liquid products: Greater than or equal to 10% of total calories from added sugars (previous exemption for beverages with less than 10kcal of added sugars removed)
    • Warning threshold for excess sodium for solid products: Greater or equal to 1 mg of sodium per kcal or greater than or equal to 300 mg per 100g of product (previously greater than or equal to 350 mg per 100g of product).
  • Phase 2 will also involve a review of the existing thresholds to determine if further changes are necessary. Phase 3, which will assess phase 2 criteria, will not begin until October 1, 2025.
  • A summary of the thresholds for FOP warnings (including carryovers from phase 1) can be found at USDA’s Foreign Agricultural Service webpage.

  • As we have previously reported, in September 2020, Mexico and Canada signed a Statement of Intent (SOI), which expanded the countries’ partnership in dealing with food safety issues. Among other things, the 2020 SOI expanded the partnership to include all foods traded between the countries and encouraged the development and use of new technologies to improve food safety.
  • On August 20, 2021, FDA and its regulatory counterparts in Mexico (Cofepris and SENASICA) held the first Food Partnership Annual meeting in which they discussed the accomplishments and goals of the partnership. The discussion was summarized in a recent press release by Frank Yiannis, FDA Deputy Commissioner for Food Policy and Response. (See also Constituent Update)
  • Specifically, Mr. Yiannis stated that the agencies were continuing to work on four strategic priorities: (1) foodborne illness prevention, (2) enhanced coordination for outbreak response, (3) regulatory laboratory coordination, and (4) food safety training opportunities for industry. The agencies’ efforts included sharing analytical methods and laboratory protocols to improve detection and reduce exposure to food illness pathogens, sharing outbreak data to improve outbreak response communications, and working to revise a coordinated outbreak response protocol. Mr. Yiannis also announced progress in training industry on best agricultural practices, including the training of 90% of the Mexican papaya industry on papaya growing best practices.
  • Keller and Heckman will continue to monitor and report on developments in the regulation of food safety.
  • Mexico’s Federal Consumer Attorney’s Office (PROFECO) and other Mexican agencies have recently agreed to provide the food industry with more flexibility to comply with requirements in the Official Mexican Standard NOM-051 (“NOM-051”) that become effective on April 1, 2021.  NOM-051 sets forth new warning labeling requirements for all prepackaged food and non-alcoholic beverages sold within Mexico.
  • As we have reported in the past, in late 2020, Mexico’s NOM-051 began requiring manufacturers to place octagonal warning symbols in consumer products that state “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.” NOM-051 imposed a number of other requirements that were slated to become effective on April 1, 2021.  For example, prior to the PROFECO announcement, Clause 4.2.2.1.8 (requiring that all added sugar ingredients be grouped in the ingredient list) and Clause 4.1.5 (prohibiting prepackaged products with FOP warnings from bearing cartoon characters, animations, celebrities, athletes or pets, interactive elements (e.g., such as space games or digital downloads) that appeal to children) were to become effective on April 1, 2021.
  • PROFECO has stated that between April 1, 2021 to May 31, 2021, Mexican authorities will allow companies’ products that comply with already-effective FOP labeling requirements to continue to be marketed even if they do not comply with other requirements that would have otherwise become effective April 1, 2021.
  • On January 26, FDA placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert in an effort to stop violative products from entering the US market until the Agency is able to review the products’ safety. See FDA’s Press Release. Under the import alert, FDA may detain shipments of the alcohol-based hand sanitizers from Mexico, and as part of the entry review, FDA will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured in accordance with US current good manufacturing practices (cGMPs). This is the first time the FDA has issued a countrywide import alert for any category of drug product.
  • Over the course of the ongoing COVID pandemic, the FDA has seen an increase in hand sanitizer products from Mexico that were labeled to contain ethanol, but tested positive for methanol. Methanol, or wood alcohol, can be toxic when absorbed through the skin and life-threatening when ingested and is not an acceptable ingredient in hand sanitizer or other drugs. The FDA is aware of methanol-contaminated hand sanitizer adverse events, including blindness, cardiac effects, effects on the central nervous system, hospitalizations, and death.
  • From April to December 2020, the FDA analyzed alcohol-based hand sanitizers imported from Mexico and found that 84% of the samples were not in compliance with FDA regulations. More than half were found to contain toxic ingredients, including methanol and/or 1-propanol.
  • Methanol-contaminated hand sanitizers are a serious safety concern for the FDA, and the Agency has been proactively working with companies to recall products and encourage retailers to remove violative products. Further, since July 2020, the FDA has issued 14 warning letters to manufacturers for distributing hand sanitizers with undeclared methanol, inappropriate ethanol content, and misleading claims.
  • The FDA and two Mexican regulatory agencies, the National Service of Agro-Alimentary Public Health Safety and Quality (SENASICA) and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), have signed a statement of intent (SOI) that strengthens and expands upon their 2014 Produce SOI.
  • The most recent SOI broadens the scope of the partnership to cover all foods that are traded between the U.S. and Mexico. Furthermore, it encourages the development and use of new technologies to prevent and respond to foodborne illness outbreaks and also encourages collaboration with other governmental agencies and non-governmental entities including industry, consumer groups, and academia.
  • This partnership, including its emphasis on the development new technologies, is an important step in furthering the goals laid out this past summer by the FDA in their New Era of Smarter Food Safety Blueprint. And, it is an impactful one for U.S. consumers, as approximately one third of all food and sixty percent of produce in the U.S. is imported from Mexico. Keller and Heckman will continue to monitor and report on food safety issues.
  • New laws in several Mexican states will place a complete ban on the sale of food high in sugar to children, which will include harsh penalties on any sellers that disobey the directives including fines, and even jail time for repeat offenders.
  • By way of example, in Tabasco, Mexico, there is now a prohibition of the “ the sale, distribution, donation, gift, and supply of prepackaged sugary drinks, carbonated sugary drinks, sweets and prepared foods with a predominance of refined carbohydrates and vegetable fats in their solid form that contain hydrogenated fatty acids in their trans form, to minors [under the age of 18], as well as their consumption in medical and educational centers.”  Moreover, the State of Tabasco will prohibit vending machines in education centers, public and private hospitals, clinics, and health centers.  In Oaxaca, Mexico, a similar law will forbid the sale, distribution and promotion of sugary drinks, and junk food to those under age.   It will also apply to vending machines in schools.  These states will continue to allow parents or legal guardians to purchase these types of products for their children.
  • In regard to the advertising of foods high in sugar, the State of Tabasco will prohibit advertisements, posters or any type of advertising referring to the aforementioned products within a 300 meter radius from any educational centers, medical centers, and hospitals.  In addition, the price to advertise in authorized locations will increase by 25 percent.
  • These new laws follow a host of measures over the years that aim to reduce consumption of food high in sugar, including a new food labeling law, which will go into effect in October.  Other Mexican state governments, including Mexico City, Colima, Guanajuato, San Luis Potosi, and Tamaulipas have shown interest in adopting similar initiatives.   We will continue to monitor any developments.
  • In response to the Mexican Council of the Consumer Products Industry’s (“ConMéxico”) request for the postponement of Official Mexican Standard NOM-051 (“NOM-051”), Mexican authorities have stated that food and beverage companies may use provisional stickers between October 1, 2020 and March 31, 2021, which will help companies gradually comply with NOM-051.  NOM-051 sets forth a frontal labeling system for prepackaged food and non-alcoholic beverages and informs consumers when products contain high calories, added sugars, saturated fats, sodium, and caffeine.  NOM-051 will come into effect on October 1, 2020.
  • NOM-051 was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) on March 27, 2020.  NOM-051 requires manufacturers to place octagonal warning symbols in consumer products that state “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.”  NOM-051 also prohibits the use of characters, drawings, celebrities, gifts, offers, toys, or contests on food packaging.
  • By way of background, on April 28, 2020, the Mexican Council of the Consumer Products Industry (“ConMéxico”), which represents more than 40 major food and beverage producers, urged the Mexican government to postpone the effective date of NOM-051 to remove the additional pressure for the food industry in the midst of COVID-19.  In a virtual conference, Jaime Zabludovsky, president of ConMéxico, urged the government to postpone NOM-051, which will require the relabeling of more than 800,000 products that will require the assistance of nutritionists, food engineers, designers, among others who are not working at their full capacity due to the pandemic.
  • The use of provisional stickers to comply with the octagonal warning requirement will give companies more time so that they do not have to print labels for all of their products before October 2020.  Moreover, companies will be able to place provisional stickers on packaging that they already have in stock to lessen the impact.   We will continue to monitor any developments.
  • On October 11, Mexico’s lower legislative house passed a bill that would require manufacturers to place front-of-pack (FOP) warning labels on food high in sugar, sodium, or saturated fat.  The bill was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) and consists of a draft amendment to the General Labelling Specifications for Prepackaged Foods and Non-Alcoholic Beverages-Commercial and Health Information.
  • Mexico’s current FOP labeling provides information on the quantities of and percent daily values for saturated fat, total fat, total sugars, sodium, and calories in foods.  The proposed amendments would require manufacturers to place an octagonal warning symbol, stating “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.”  While FOP labeling is increasingly common in Central and South American countries, a unique provision of the Mexico bill is that it would also include a warning for foods containing artificial sweeteners, stating “Contains Sweeteners – Avoid in Children.”
  • Those interested in commenting on the draft amendment have 60 calendar-days to submit comments. The bill will now go to the Senate, where it is expected to pass, and then to President Andres Manuel Lopez Obrador, who has expressed support for the bill.
  • The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has regulatory authority over both the import and export of livestock products.  In the import context, APHIS works to ensure that products entering the U.S. meet the Agency’s entry requirements to exclude pests and diseases.
  • In July 2014, USDA published a proposed rule (79 FR 43974) that would have recognized Mexico as a low-risk classical swine fever (CSF) region. Since the rule was published, the World Organization for Animal Health recognized Mexico as CSF-free.  As a result, Mexico’s government requested that APHIS suspend its rulemaking and instead continue evaluating Mexico’s CSF status.  APHIS reopened its evaluation and conducted a site visit in 2015. Based on the 2015 site visit report, along with updated surveillance data and additional information submitted by Mexico’s government, APHIS determined that current conditions support CSF-free recognition for all of Mexico.
  • On August 8, 2017, APHIS published a Notice (82 FR 37043) which proposes to recognize Mexico as free of classical swine fever (CSF).  In announcing the publication of this Notice, APHIS also noted that it will withdraw the 2014 proposed rule that would have recognized Mexico as a low-risk CSF region. Recognizing Mexico as CSF-free could potentially create new opportunities for Mexican pork products in the U.S. market.
  • APHIS will be accepting comments on the Notice for 60 days (or until October 10, 2017) prior to making a final determination on Mexico’s CSF status which will ultimately be published in the Federal Register.
  • Florida Natural Growers, Inc., was recently sued for allegedly falsely representing its Florida’s Natural orange juice products as being exclusively made from premium Florida orange juice despite being blended with juice from other countries. The plaintiff claims that Florida Natural knew that consumers would rely on Florida representations made on the label and be willing to pay more for Florida orange juice.
  • According to the complaint, labeling on the front of the package claiming “Owned by Florida Farmers” next to an American flag, as well as language on the side panel of the package about why the company is “different,” imply that the orange juice is made exclusively from Florida oranges. Further, the American flag is claimed to be an implied “Made in the USA” claim, which is regulated by the Federal Trade Commission and only permissible where “all or virtually all ingredients . . . are made and sourced in the United States.” 16 CFR 323.2.
  • The complaint also alleges that there is a strong connection between Florida and the citrus industry such that “consumers overwhelmingly preferred Florida orange juice” and are willing to pay a premium of approximately 50% for 100% Florida orange juice.
  • However, according to the plaintiff, because of a decline in citrus groves in Florida due to plant diseases, Florida Natural began including orange juice from Mexico and Brazil in its products beginning in 2022. Thus, the plaintiff claims, the claims on the orange juice label are misleading and deceptive.
  • Keller and Heckman will continue to monitor this case and other class action lawsuits related to food labeling.