“Natural” Lawsuit Filed Over Fruit Drinks with Malic Acid as an Ingredient

Bai Fruit Drinks Sued Over ‘All-Natural’ Labeling (subscription to Law360 required)

  • A national putative class action lawsuit (with proposed in-state subclass) was filed in California federal court on April 19, 2018 against Bai Brands, LLC alleging violation of California’s Consumers Legal Remedies Act, Unfair Competition Law, and common law, as well as the U.S. Food and Drug Administration’s (FDA) regulations.  The plaintiff alleges that Bai Brands falsely advertised fruit drinks as ‘natural’ and did not disclose malic acid, alleged to be a synthetic flavor used to mimic fresh fruit, on front of package labeling.  (Branca v. Bai Brands, LLC, 3:18-cv-00757).
  • Natural lawsuits continue to proliferate despite court ordered stays being granted in several challenges due to pending FDA action.  As previously covered on this blog, FDA is considering whether to regulate the term “natural,” having collected 7,687 comments in 2016 on use of the term ‘natural’ on human food labeling.
  • Commissioner Scott Gottlieb acknowledged the lack of clarity on the meaning of ‘natural’  in March 29, 2018 remarks at the National Food Policy Conference in Washington, DC and said FDA “will have more to say on the issue soon.”  It remains to be seen how long courts will continue to wait for FDA to act.


Front of Pack Labeling Being Discussed in NAFTA Negotiations

  • As first reported by the New York Times, and later confirmed under questioning by Rep. Doggett in a House Ways and Means Committee hearing, one plank of the United State’s platform in the renegotiation of the North America Free Trade Agreement (NAFTA) is the limitation on member countries from requiring front of pack labeling on foods that would indicate using symbols, like a stoplight, which foods are more or less healthy.
  • In a report, IEG Policy News noted that certain industry groups oppose mandatory front of pack labeling using such symbols because they oversimplify the information.  For example, the International Dairy Food Association notes that dairy products are nutrient rich and their consumption should be encouraged even though they may be considered high in calories or fat under some front of pack labeling regimes.  Industry groups are largely in favor of the voluntary Facts Up Front initiative, which does not include symbols to demarcate healthy or unhealthy choices.  Consumer advocacy groups, like Center for Science in the Public Interest, oppose restrictions on countries’ ability to impose mandatory warnings.
  • As we have seen in the battle over determining what foods are healthy, there are many ways that labeling could help promote or restrict the consumption of foods that generally promote a healthy lifestyle.  Determining which foods are healthy represents a policy choice that has yet to be made.  The fight over front of pack labeling appears to fall into the same rubric.  Keller and Heckman will continue to monitor and report.

GAO Releases Report Recommending Additional FDA Action to Address Arsenic in Rice

  • In response to the U.S. Food and Drug Administration’s (FDA’s) 2016 Arsenic in Rice and Rice Products Risk Assessment Report, the Government Accountability Office (GAO) released a report on April 16, 2018 acknowledging the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) efforts to develop methods to detect arsenic in rice but concluding that FDA could improve risk communications to the public, as well as coordination with other agencies to address arsenic in rice.
  • GAO recommends that FDA develop a timeline for updating its risk assessment and finalizing its draft guidance and that FDA and USDA develop a coordination mechanism for developing methods to detect foodborne contaminants, including arsenic.
  • Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, released a statement on April 17, 2018 in which she concurs with the GAO recommendations and notes that the agency is seeking to establish an action level for inorganic arsenic in infant rice cereal by the end of 2018.

International Food Safety Leaders Adopt and Advance Food Safety Provisions Discussed at the 12th Session of the Codex Alimentarius Committee on Contaminants (and Toxins) in foods (CCCF)

  • The 12th session of the Codex Alimentarius Committee on Contaminants (and Toxins) in foods (CCCF) was held in Utrecht (The Netherlands) from March 12-16, 2018. CCCF is the Codex Alimentarius horizontal committee in charge of updating the General Standard on Contaminants and Toxins in Foods and adopting codes and guidelines for the reduction and prevention of the contamination of the food chain.
  • Of note, CCCF12 reviewed and discussed proposed draft Codex Guidelines to define the risk analysis principles on the inadvertent low level presence of chemicals in foods. The discussion highlighted the need to narrow the scope of the guidelines, meaning food additives, pesticide residues, and residues of veterinary drugs will be specifically excluded. The Committee also noted the approach on how guidance levels (alert levels) are derived need to be further addressed and applicability reassessed. Despite the remaining work on the guidelines, the Committee considered the text ready for adoption at Step 5 (out of 8) by this July CAC41. Therefore, CCCF12 established an electronic working group (EWG) to further develop the guidelines. Although not formally established by CCCF12, CCCF12 leaves the door open to the chairs from New Zealand and the Netherlands to organize a physical working group (PWG) to meet immediately prior to CCCF13 session to make further recommendations to the Committee, based on the text to be included in the EWG report.
    • It is worth noting that based on the draft guidelines, it appears the intent is for governments to use the Codex guidelines to implement harmonized national policies regulating the migration of contaminants (i.e., non-intentionally added substances). This move of Codex CCCF into the regulation of food contact materials is quite significant.
  • CCCF12 also reviewed a recommendation for a maximum limit (ML) of 10 micrograms per kilogram (μg/kg or ppb) total aflatoxins in ready-to-eat peanuts. Instead of completely phasing out the objective to develop a Codex ML, the Committee stopped discussion and requested additional data on ready-to-eat peanuts (not intended for further oil processing) which are subject to international trade (i.e., not to domestic consumption from local producers). The call for new data, to be coordinated by JECFA, will grant an additional “grace” period for the main producing and exporting countries to implement the 2004 Codex Code of Practice for the prevention and reduction of aflatoxins in ready-to-eat peanuts. The Committee acknowledged that some confusion exists on current occurrence data about peanuts intended for further processing (edible oil production). Thus, the Committee decided to keep, but put on hold, the draft ML for total aflatoxins at 10 μg/kg in ready-to-eat peanuts. The discussion will resume once JECFA reports on the new occurrence data in approximately 4 or 5 years. This delay, however, may provide national or regional authorities the time to set their own national limit.
  • CCCF12 set new international standard maximum limits for lead, cadmium, methyl mercury, and other contaminants and toxins in several types of foods (e.g., chocolate, fish products, salt, fat spreads, etc.). For example, CCCF12 agreed to suggest the adoption of lowered maximum tolerable levels (MLs) for lead in several food categories in the Codex Alimentarius General Standard in Contaminants and Toxins in Food (GSCTF) and, where appropriate, in the corresponding Codex Commodity Standard. In particular, CCCF12 discussed lead limits in, for example, quinoa, grape juice, processed tomatoes, mango chutney, and wine. Looking towards the future, CCCF12 tasked the Codex Alimentarius Commission’s, JECFA’s and the Netherlands’ secretariats, with the assistance of the EU, to determine whether the Committee has now covered all main staple foods subject to international trade and of public health concern. CCCF12 also established MLs for Cadmium in various chocolate and chocolate products.
  • A detailed review of CCCF12 can be found at khlaw.com.  If you have any questions or for more information, please contact Katia Merten-Lentz (mertenlentz@khlaw.com) or Christophe Leprêtre (lepretre@khlaw.com).

FDA Targets Highly Concentrated Caffeine in Dietary Supplements

  • As previously reported on this blog in 2015, FDA warned that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” The Agency made this announcement shortly after sending Warning Letters to five companies that distributed pure powdered caffeine. In the letters, FDA stated that it concluded that pure powdered caffeine is adulterated under Section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) based on the potential toxicity of the product.
  • On April 13, 2018, FDA issued a new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. In a press release concerning the guidance, FDA Commissioner Scott Gottlieb, M.D., explained:
    • “Despite multiple actions against these products in the past, we’ve seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container. … We’re making clear for industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law. We’ll act to remove these dangerous bulk products from the market.”
  • The guidance is intended to assist firms that manufacture, market or distribute dietary supplements products that contain pure or highly concentrated caffeine in determining whether their products are adulterated under Section 402(f)(1)(A) of the FD&C Act. It also includes a list of the types dietary supplements containing caffeine that the FDA does not consider to be adulterated.

Reopening of Public Comment Period for USDA’s Proposed Amendments to the National List of Allowed and Prohibited Substances under the Organic Foods Production Act


  • The public comment period for the United States Department of Agriculture (USDA) Agricultural Marketing Service’s (AMS) proposed rule describing 35 amendments to the National List of Allowed and Prohibited Substances (Crops, Livestock and Handling) was to have closed on March 19, 2018. On Friday, at the request of multiple stakeholders, USDA reopened the comment period for an additional 30 days. See 83 Fed. Reg. 16010 (April 13, 2018).
  • USDA’s proposed rule, published in 83 Fed. Reg. 2498 (January 17, 2018), would amend the National List of Allowed and Prohibited Substances (National List) provisions of USDA’s organic regulations to implement 29 recommendations submitted by the National Organic Standards Board (NOSB) on 35 amendments to the National List. The NOSB is authorized to assist in the evaluation of substances to be included on the National List in an advisory role. Many of the NOSB recommendations addressed in the proposed rule have been in USDA’s hands for several years. The recommendations were submitted on November 17, 2000, September 19, 2002, May 6, 2009, November 5, 2009, October 28, 2010, December 2, 2011, March 20, 2012, October 16, 2012, May 2, 2014, April 30, 2015, October 29, 2015, April 26, 2016, and November 18, 2016.
  • USDA’s rule proposes to change the use restrictions for seventeen substances currently allowed for organic production or handling: Micronutrients; chlorhexidine; parasiticides; fenbendazole; moxidectin; xylazine; lidocaine; procaine; methionine; excipients; alginic acid; flavors; carnauba wax; chlorine; cellulose; colors; and, glycerin.
  • The rule also proposes to add sixteen new substances to be allowed in organic production or handling: Hypochlorous acid; magnesium oxide; squid byproducts; activated charcoal; calcium borogluconate; calcium propionate; injectable vitamins, minerals, and electrolytes; kaolin pectin; mineral oil; propylene glycol; acidified sodium chlorite; zinc sulfate; potassium lactate; and, sodium lactate.
  • In addition, the proposed rule would list the botanical pesticide, rotenone, as a prohibited substance in organic crop production.
  • Finally, the proposed rule would remove ivermectin as an allowed parasiticide for use in organic livestock production.
  • The new deadline for commenting on USDA’s proposed amendments to the National List is May 14, 2018.


Food Policy Summary

  • In the last week there have been a number of interesting developments in food policy.  Each is in early development, but worthy of a brief note.
  • President Trump, in a meeting regarding Chinese tariffs with Republican lawmakers from agricultural states, indicated a willingness to reconsider participation in the Trans-Pacific Partnership (TPP), perhaps as a means of blunting the impact of retaliatory tariffs.   In a post earlier this week, The Daily Intake Blog reported that USDA asserted that American farmers would be protected in the trade dispute but that USDA had not put forth a plan at that time.  Trade groups and law makers are pleased with the possibility of reentering the TPP.
  • Language for the farm bill was released on April 12.  A summary of the bill from the House Agriculture Committee can be found hereInitial reactions have been focused on the increased burdens on recipients of Supplemental Nutritional Assistance Plan (SNAP) funds, commonly referred to as food stamps, and Democratic lawmakers have vowed to fight the bill on this basis.  Other provisions in the bill of note include funds for development of rural infrastructure, increased emphasis on animal health, elimination of the requirement that the United States Environmental Protection Agency (EPA) consult with other agencies regarding the impact of registration of a new pesticide on could harm threatened or endangered species of wildlife and increased funding to prevent fraudulent labeling of imported foods as organic.
  • On April 11,  a bill was introduced in the Senate as a companion to the Food Labeling Modernization Act (HR 5425) introduced in the House on April 2, 2018.  Though the language for the Senate bill has not been posted yet, the House bill would require more consumer friendly labeling including requirements for FDA to define “healthy” and “natural” and for packaged foods to have simplified “front of pack” labels which would highlight the presence of certain nutritional information, including sugars, fats, and salt.
  • We will continue to monitor each of these developments and provide updates on The Daily Intake Blog as new information emerges.

California Adopts Safe Harbor for Glyphosate under Proposition 65

  • On April 6, 2018, California’s Office of Environmental Health Hazard Assessment adopted a No Significant Risk Level (NSRL) of 1,100 micrograms per day for glyphosate.
  • Glyphosate was listed as a carcinogen on July 7, 2017.  In theory, failure to warn for glyphosate exposure exceeding the NSRL would become mandatory on July 7, 2018.
  • However, a federal district court recently granted an injunction to plaintiffs from providing warnings for glyphosate because such warnings would not be “factually accurate.”  Given that the litigation is still pending, it is not yet certain how the duty to warn for glyphosate exposures will be enforced in the future.


United Kingdom’s Sugar Tax on Beverages Takes Effect

  • On April 6, 2018, the United Kingdom’s sugar tax on sodas and soft drinks took effect. As previously reported on this blog, several cities in the United States already tax soft drinks, as do countries like Mexico, France, and Portugal.
  • The Soft Drinks Industry Levy applies to non-alcoholic beverages (i.e., under 1.2% ABV) with added sugar. A drink is considered to contain “added sugar” if sugar has been added at any stage during production. This includes pure cane sugars, like sucrose and glucose, as well as substances that contain sugar, like honey. The tax applies to packaged beverages, but does not apply to milk-based drinks, 100% fruit juice, de-alcoholised beer and wine, drinks with less than 5g sugar per 100mL, and those from small producers. The tax rate for added sugar drinks with a total sugar content of 5g or more per 100mL is 18 pence (25¢ US) per liter, and those with 8g or more per 100mL is 24 pence (34¢ US) per liter.
  • The tax is applied to manufacturers of the soft drinks, and unsurprisingly, the beverage industry has been against such sugar taxes. Originally, the Treasury forecast it would raise more than £500m a year from the tax, but that has now been reduced to £240m because over 50 percent of manufacturers have reduced the sugar content in their products. The income raised from the tax is to be invested in school sports and school breakfast clubs.

More on Tariff Dispute with China: USDA Secretary Says Farmers Will be Protected

  • The U.S. will protect its farmers during rising trade tensions between the U.S. and China, Agriculture Secretary Sonny Perdue told the National Rural Electric Cooperative Association yesterday (see Reuters). This follows a statement from USDA last week stating that it was looking for ways to shield farmers from the conflict between China and the U.S.
  • As previously reported on this blog last week, increased Chinese tariffs on a number of U.S. exports—including pork and certain fruits, nuts, and wine products—raised concern for agricultural producers. In response to those increased tariffs that became effective April 2, the U.S. announced possible new tariffs on Chinese products and China retaliated by threatening to impose tariffs on more U.S. products, including soybeans and beef. (USDA reports on the tariffs imposed and threatened by China on certain U.S. products can be found here and here.)
  • Senators from states that depend on agricultural exports have weighed in on the growing conflict between the U.S. and China.
    • Senator Joni Ernst (R-IA) stated in a press release, “Soybean farmers are perhaps the most vulnerable to Chinese retaliation as nearly one in every three rows of soybeans grown in the U.S. is exported to China – valued at $14 billion every year…There is a real danger that increased tariffs on U.S. exports will harm Iowa producers and undermine the rural economy.”
    • Senator Ben Sasse (R-NE) issued a stronger statement about the tariffs: “Hopefully the President is just blowing off steam again but, if he’s even half-serious, this is nuts. China is guilty of many things, but the President has no actual plan to win right now. He’s threatening to light American agriculture on fire. Let’s absolutely take on Chinese bad behavior, but with a plan that punishes them instead of us. This is the dumbest possible way to do this.”
    • Senator Dianne Feinstein (D-CA) called on the Trump administration to take steps to protect California agriculture from an escalating trade war with China. In an April 4 letter to Secretary Perdue, she stated: “President Trump has stated that the recent tariff announcements are intended to protect American jobs, but so far the only concrete result appears to be fewer markets and higher costs for farmers and ranchers. International trade is increasingly important and I am concerned that the voices of our farmers are not being heard by the administration.”
  • A study released by Purdue University on March 28, 2018, determined that soybean exports to China could drop by as much as 71% if China imposed trade restrictions on U.S. soybeans. Currently, the soybean trade is relative unrestricted by tariffs or other border measures, said Wally Tyner, one of the study’s authors.
  • Neither Secretary Purdue or President Trump have provided details on how farmers would be protected. However, in a April 9 USDA broadcast, Secretary Purdue re-emphasized, “We’re not going to allow agricultural producers to bear the brunt of China’s retaliation as we defend our own interest as a nation.” He added that he hoped that China and the U.S. will negotiate before the tariffs go into effect.