- Country of Origin Labeling (COOL) requirements at 7 CFR Part 60 and 7 CFR Part 65 require retailers to notify their customers of the country of origin of covered commodities, which include muscle cut and ground lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng. For example, seafood sold at grocery stores would be subject to the federal COOL requirements. However, a Louisiana bill would require those same requirements to extend to restaurant menus.
- House Bill No. 335 would require Louisiana restaurants to label menus with the origins of shrimp and crawfish. The proposed law would require all restaurants that use a menu as a standard business practice and sell cooked or prepared crawfish or shrimp that originate outside of the U.S. to display on all menus the country of origin in letters no smaller than one-half inch in size, in English, immediately adjacent to the menu listing of the seafood item being sold. For restaurants that do not use a menu, a sign may be posted at the main entrance that notifies customers of the country of origin of the crawfish and shrimp. Any violation of the proposed law would constitute a violation of the state’s sanitary code. House Bill No. 335 has passed the Louisiana state house with unanimous support, and is currently under consideration by the Senate Health and Welfare Committee.
- Louisiana is not the first state to use country of origin labeling laws in restaurants. Indeed, Alabama, Arkansas, Mississippi, Louisiana, and Tennessee all have state laws requiring origin labeling for catfish on restaurant menus.
- House Bill No. 335 is not the only food labeling-related bill currently in the Louisiana state legislature. Senate Bill No. 39, if passed, would prohibit plant-based milks from being labeled as “milk” and Senate Bill No. 152 would ban plant-based and cell-cultured meats from using the term “meat” on labels and in labeling.
FDA Extends Application Deadline for VQIP
- The U.S. Food and Drug Administration (FDA) announced that the application period for importers to submit their notice of intent to participate in the Voluntary Qualified Importer Program (VQIP) for the Fiscal Year 2020 benefits period has been extended to July 31, 2019. (In a previous blog, we noted that the VQIP application portal opened on October 1, 2018, for the FY 2020 benefit period.) Established by the Food Safety Modernization Act (FSMA), VQIP is a fee-based program that provides expedited review of human and animal foods imported into the United States.
- To participate in the VQIP, importers must meet eligibility criteria. This includes ensuring that the foreign supplier’s facilities are certified by a recognized certification body that has been accredited through FDA’s Accredited Third-Party Certification Program. (For more information on FDA’s Accredited Third-Party Certification Program, see our previous blogs here and here.) As of May 1, 2019, four third-party certifications bodies have received accreditation.
- Keller and Heckman attorneys regularly advise on FSMA-related compliance, including the Third-Party Certification Program and the VQIP.
FDA Greenlights Use of “Potassium Chloride Salt” as an Alternative Name for “Potassium Chloride” in Food Labeling
- Under section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the label of food fabricated from two or more ingredients must bear the common or usual name of each ingredient. As we have reported, however, a number of health advocacy groups, food manufacturers, and food retailers argued to the Food and Drug Administration (FDA) that use of the name “potassium chloride salt” instead of the common or usual name for this ingredient on food labeling would lead to increased consumer understanding of the use of potassium chloride as a replacement for sodium chloride (i.e., salt). The group found that in this era of clean labeling, consumers are suspicious of “chemical-sounding” ingredients and may mistakenly believe potassium chloride to be an “undesirable chemical substance” that should be avoided.
- FDA’s May 17, 2019 Constituent Update announces a new draft guidance for Use of an Alternate Name for Potassium Chloride in Food Labeling (May 2019 Draft Guidance). Specifically, FDA has advised food manufacturers of the Agency’s intent to exercise enforcement discretion for declaration of the name “potassium chloride salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.” FDA hopes that allowing the declaration of potassium chloride salt on food labels may encourage manufacturers to use potassium chloride as an alternative to sodium chloride because it may correct the consumer misconception that is associated with the common name of the ingredient. This policy aligns with FDA’s previous activities to encourage manufacturers to reduce the sodium levels in food products in the interest of public health and with FDA’s Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States.
- Comments on the draft guidance for the use of potassium chloride salt in food labeling should be submitted to FDA by July 16, 2019 to ensure that they are considered before FDA plans to begin work on the final guidance.
- We will continue to monitor developments regarding the common or usual name of potassium chloride in Canada where our readers may remember a request was submitted to Health Canada and the Canadian Food Inspection Agency (CFIA) to allow “potassium salt” to be used as a permitted synonym for potassium chloride on food labels.
European Food Safety Authority Responds to French Ban of Titanium Dioxide in Food
- On April 25, France adopted an executive order banning the placement of foods containing titanium dioxide on the market for one year beginning January 1, 2020. See our blog on the topic here.
- On May 13, the European Food Safety Authority (EFSA), published a statement on the risk review performed by the French Agency for Food, Environmental and Occupational Health and Safety (ANSES). EFSA concluded, in part, that the ANSES evaluation did not identify any new information that would overturn EFSA’s previous scientific assessments of titanium dioxide, the most recent of which was published in 2018. For more, see the blog post in the Tomorrow’s Food and Feed blog.
- France’s executive order was the topic of the European Commission Standing Committee on Plants, Animals, Food and Feed Section Novel Food and Toxicological Safety of the Food Chain’s May 13 meeting. One major topic of concern is that a member state unilaterally reversed course on a safety determination made by Europe as a whole less than a year after the determination had been made – raising concerns about Europe’s ability to maintain a uniform regulatory landscape.
Bayer/Monsanto Hit Again With $2 Billion Verdict in Roundup Case
- This blog has closely followed litigation surrounding allegations that glyphosate has caused non-Hodgkin lymphoma in a number of plaintiffs. In March, a California jury awarded $80 million in damages to a plaintiff who used Monsanto’s Roundup on his 56-acre property. This verdict was the second significant glyphosate judgment against Bayer-owned Monsanto, following on the August 2018 verdict that awarded a former school groundskeeper $289 million (later reduced to $78 million by a judge reviewing the case).
- Most recently, on May 12, in Pilliod v. Monsanto, a California jury concluded that Monsanto’s Roundup caused a couple to suffer non-Hodgkin lymphoma after years of using the herbicide and awarded the plaintiffs a total of $2 billion in punitive damages and $55 million in compensatory damages.
- This is the third consecutive loss for Bayer AG, which acquired Monsanto in June 2018, and the third to go to trial out of about 13,400 cases pending that allege Roundup causes cancer. Bayer said in a statement that the company is disappointed with the jury’s decision and will appeal the verdict.
Health Canada Urged to Allow the Term “Potassium Salt” on Food Labels
- In a letter to Health Canada and the Canadian Food Inspection Agency (CFIA), a number of health advocacy groups, food manufacturers, and food retailers have urged regulators to allow “potassium salt” to be used as a permitted synonym for potassium chloride on food labels. As reported by FoodNavigator, the group argued that the addition of “potassium salt” to the Permitted Synonyms for Food Additives Table would reduce sodium intake in Canada because “a friendlier name would demystify the ingredient and help the industry achieve the dual goals of lowering sodium and increasing potassium intakes.”
- The group argued that Health Canada’s current requirement for potassium salt to be labeled as “potassium chloride” on food labels is “inconsistent with growing consumer demands for clean label food ingredients and it could inhibit consumer acceptance of this salt substitute.” Indeed, the group found that in this era of clean labeling, consumers are becoming increasingly suspicious of “chemical-sounding” ingredients. Relying on consumer research, the group maintained that some consumers mistakenly believe potassium chloride to be an “undesirable chemical substance” and one that should be avoided. Thus, food manufacturers are often hesitant to use potassium salt as a substitute when it must be declared as “potassium chloride.”
- There is clear precedent for allowing the use of permitted synonyms on food labels. The CFIA has previously established synonyms for a variety of other ingredients, such as “baking soda” for sodium bicarbonate and “lye” for sodium hydroxide.
- As our readers may remember, the FDA received a similar request in 2016. NuTek Food Science filed a citizen petition requesting that the agency recognize “potassium salt” as a common or usual name for potassium chloride, and to permit the ingredient to be labeled as such on US food labels. FDA has yet to respond to NuTek’s petition, although former Commissioner Gottlieb hinted at support for the petition in March 2018 when he announced the Nutrition Innovation Strategy. FDA has publicly stated in multiple forums that they will continue to pursue the goals set forth in the Nutrition Innovation Strategy. As such, we will continue to monitor for any developments regarding the common or usual name of potassium chloride in the US and Canada.
Food Companies Agree to Phase Out Industrially Produced Trans Fat by 2023
- As previously reported on this blog, the World Health Organization (WHO) released a plan in May 2018 aimed at eliminating industrially-produced trans fatty acids from the global food supply. On April 26, 2019, WHO Director-General Dr. Tedros Adhanom Ghebreyesus issued a statement about that plan. He said in the statement, “The elimination of industrially-produced trans fat from the global food supply is a WHO priority and a target in the 13th General Programme of Work (GPW), which will guide the WHO through 2023.” To meet this target, WHO called on the fats, oils, food, and food service industry to commit to the following:
- Reformulate foods to eliminate industrially-produced trans fat: Set, commit to, and meet trans-fat elimination targets by 2023 or earlier for all products across global product lines, in line with the WHO recommendation for all food categories (<2 grams per 100 grams of total fat or oil in all foods) without replacement with saturated fat.
- Label trans fat content: Implement trans fat labelling on any pre-packaged food.
- Increase supply of healthier fats and oils: Increase the supply of replacement alternatives low in saturated fat.
- Evaluate commitments: Support the implementation of an independent evaluation to monitor the progress and achievement of commitments made, including disclosing annually the company volume of production of industrially-produced trans fat and country-specific quantity of the volume of sales.
- On May 7, 2019, the International Food & Beverage Alliance (IFBA) announced that twelve global food and beverage companies pledged to meet WHO’s goal to phase out industrially-produced trans fat from their products (or to not exceed 2 grams of industrially-produced trans fat per 100 grams of fat or oil). Additionally, IFBA stated that its members “will seek wherever possible to avoid that reformulation efforts to meet this [industrially-produced trans fat] commitment result in increases in saturated fat content.” WHO Guidelines recommend that adults and children reduced their intake of saturated fatty acids to less than 10% of total energy intake and their intake of trans fatty acids to less than1% total energy intake.
- In the U.S., the Food and Drug Administration (FDA) issued its final rules to implement changes to nutrition labeling requirements on May 20, 2016. Fat is among the items addressed in the new nutrition labeling requirements that are currently scheduled to take effect on January 1, 2020 for manufacturers with $10 million or more in annual foods sales and on January 1, 2021 for manufacturers with less than $10 million in annual food sales. More specifically, the final rule on Food Labeling: Revision of the Nutrition and Supplement Facts Label requires that the amount of saturated fat and trans fats per serving is listed on the current label and will be required on the new labels.
FDA’s Quiet Reorganization of the Office of Food Additive Safety Begins Today
- Before the Food and Drug Administration (FDA) took it down this morning, the website for the Office of Food Additive Safety (OFAS) showed three divisions for (1) Food Additive Petitions (FAPs) and Color Additive Petitions (CAPs), (2) Food Contact Notifications (FCNs), and (3) Biotechnology and Generally Recognized as Safe (GRAS) notifications. Since the last reorganization of the Center for Food Safety and Human Nutrition (CFSAN) in 2002, these three divisions within OFAS have each had assigned teams for handling all industry submissions for new food and food-contact clearances.
- Through informal communications with FDA regarding another issue, we were told that the Division of Biotechnology and GRAS Notifications will merge with the Division of FAPs and CAPs as of today, May 13, 2019. The Division of FCNs will remain largely unchanged. Further, we understand there will be an entirely new Division of Science and Technology made up of three teams responsible for special projects, biotechnology issues, and environmental reviews. Presumably, the OFAS website will be back online shortly reflecting the new organization.
- This major reorganization was briefly mentioned (in a single bullet listing OFAS as an office to undergo proposed reorganization) within a March 21, 2019 letter from former FDA Commissioner Scott Gottlieb to FDA staff regarding larger, multidepartment reorganization efforts. FDA has not broadly announced these organizational changes in the divisions handling food ingredient submissions, which will include significant shifts of personnel to new positions with granular changes in employees’ responsibilities. With FDA employees moving to different areas and taking on new responsibilities, we would not be surprised if there are some administrative delays.
Product Recalls Decline Across All Industries in Q1 2019
- As previously reported by Food Industry Executive based on a report and press release from Stericycle Expert Solutions, recalls within the consumer products, automotive, pharmaceutical, medical device, and food and beverage industries were all down in the first quarter of 2019. This is the first time since 2012 that recalls were down across all industries monitored by Stericycle.
- Stericycle believes that the reduction in recalls “were largely due to reduced oversight from the government shutdown earlier this year which stopped or limited many government safety inspections.” Though only a partial shutdown, routine inspections were impacted for all domestic food facilities (though roughly 150 staff were brought back to work mid-shutdown to perform routine inspections at high-risk food facilities) and this may well have impacted the number of violations observed and, consequently, the number of recalls. For more on the shutdown, see the Daily Intake blog posts here, here, and here.
- Also of interest from the Stericycle report:
- One large recall accounted for 95.8% of all recalled FDA food units
- Undeclared allergens was the top cause of FDA food recalls
- Foreign material was the top cause of USDA food recalls
California’s Proposition 65 Website Posts Styrene Fact Sheet
- California’s Office of Environmental Health Hazard Assessment (OEHHA) has posted a fact sheet regarding styrene on its Proposition 65 warning website, also known as the Lead Agency Website.
- OEHHA listed styrene as a carcinogen under Proposition 65 on April 22, 2016, and on May 4, 2017, the state adopted a No Significant Risk Level (NSRL) for styrene of 27 µg per day.
- Despite stating that “the levels of such residual styrene in polystyrene food packaging materials are generally thought to be fairly low in most cases” when OEHHA issued styrene NSRL, the new fact sheet states, “Small amounts of styrene can be transferred to some food from polystyrene-based food-contact items such as drinking cups, plates, and other containers.” The fact sheet also states, “If possible, do not store or microwave food in polystyrene-based containers.”
- The new fact sheet joins a chorus of other state and local laws and initiatives that discourage or ban the use of polystyrene food packaging materials.
