FDA Issues Warning Letters to Companies Illegally Selling Unapproved, Misbranded Kratom Products

  • On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies also made claims about treating pain, as well as other medical conditions like depression, anxiety, and cancer.
  • In FDA’s press release, Acting FDA Commissioner Ned Sharpless noted that there are no FDA-approved uses for kratom and the agency has been active in warning consumers about the serious risks associated with kratom. For example, as our readers may know, FDA has warned about both the high levels of heavy metals found in kratom products and the contamination of certain kratom products with salmonella. Indeed, FDA issued its first ever mandatory recall order for the salmonella-containing kratom products.
  • The June 25 warning letters allege that the companies used their websites and social media to illegally market kratom products and made unproven claims about the ability of the products to cure, treat, or prevent disease. Examples of the claims include:
    • “Kratom acts as a μ-opioid receptor-like morphine.”
    • “In fact many people use kratom to overcome opiate addiction.”
    • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
    • “Usage: It is for the management of chronic pain, as well as recreationally.”
  • FDA reiterates that “[t]hese products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.” FDA has requested responses from both companies within 15 working days.

FDA Issues Draft Guidance on Reducing Microbial Hazards in Seed for Sprouting

  • The U.S. Food and Drug Administration (FDA) has issued a draft guidance, titled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.” This draft guidance document provides food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting.
  • FDA reported that between January 1996 and August 2018, contaminated sprouts were associated with 50 outbreaks, which resulted in more than 2,600 cases of foodborne illness. In the Federal Register notice about the draft guidance, FDA explains that the document “will make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of FDA’s serious concern with the continuing outbreaks of food borne illness associated with the consumption of raw and lightly-cooked sprouts…”
  • The Produce Safety Rule, as required by the FDA Food Safety Modernization Act (FSMA), includes sprout-specific requirements. (Keller and Heckman’s detailed summary of the rule is available here.) However, since FDA considers seeds used for sprouting to be outside the definition of “covered produce” under the rule, the Agency did not prescribe specific requirements in the Produce Safety Rule to prevent the introduction of known or reasonably foreseeable hazards into or onto seed during growing, harvesting, conditioning, or holding of seed. The draft guidance includes steps that those in the sprout seed supply chain should take to reduce microbial food safety hazards, such as proper training of personnel, storing seed for sprouting separately from seed for other uses, and ensuring that food contact surfaces are cleaned regularly.
  • The draft guidance will be available for public comment for 60 days until August 26, 2019. Comments should be identified with the docket number FDA-2018-D-4534 and can be submitted electronically at https://www/regulations.gov.
  • Keller and Heckman attorneys and scientists are experienced with advising on FSMA, Produce Safety and sprout seed, and related regulatory issues, and would be happy to answer any questions.

FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food


  • The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by FDA under 21 C.F.R. Part 117 and Part 507, respectively.  Meeting the “small business” definition has two main implications: (1) Certain small businesses (i.e., “farm mixed-type facilities”) are exempt from the human and animal food preventive controls requirements if they are engaged only in specified low-risk activity/food combinations, and (2) Small businesses have later compliance dates for parts 117 and 507.
  • As previously reported on this blog, FDA released draft guidance on March 19, 2018 for determining the number of employees for purposes of meeting the “small business” definition under parts 117 and 507.  Notably, some compliance dates applicable to small businesses have not yet passed, such as the September 18, 2019 and September 17, 2020 extended compliance dates for written assurances in the customer provisions in 21 C.F.R. §§ 117.136(a)(2)(ii), (3)(ii), and 4(ii) and 507.36(a)(2)(ii), (3)(ii), and 4(ii), respectively.
  • With a June 21, 2019 notice, FDA released its final guidance on determining the number of employees under the “small business” definition.  Having received no substantive comments on the March 2018 draft guidance, FDA made only editorial changes to improve clarity and revised one example to make it more useful.


Louisiana Laws to Limit Use of Terms “Meat,” “Rice,” “Sugar” and “Milk” on Food Product Labels

  • On June 11, Louisiana joined a growing number of states, including Missouri and Arkansas, that have enacted legislation aimed at protecting traditional agricultural products from the growing popularity of plant-based and cell-based meat products or riced vegetables.
  • Louisiana Governor John Bel Edwards signed two bills into law aimed at prohibiting the use of common labeling terms on food products derived from non-traditional sources.  Louisiana Act No. 273, or the “Truth in Labeling” law, broadly bans the use of the terms “meat,” “rice” or “sugar” on food products derived from non-traditional sources, such as plant-based or cell-derived “meats” and cauliflower “rice.”  Louisiana Act No. 184 specifically targets milk product labeling, which prohibits a beverage from being labeled as “milk” unless the product comes from a cow, goat, or other hooved mammals.  Both bills were sponsored by Louisiana Democratic Senator Francis Thompson, who claims that the legislation is designed to protect the Louisiana agriculture and dairy industries, as well as protect consumers from misleading labels.
  • The “Truth in Labeling” law makes it unlawful to represent any food product as an agricultural product unless it meets a definition prescribed by statute, or defined historically in reference to a specific agricultural product.  The law defines “meat” to mean a portion of beef, pork, poultry, alligator, farm-raised deer, turtle, domestic rabbit, crawfish, or shrimp, and does not include products derived from a plant or cell culture grown in a lab.  The law also prevents use of the term “rice” unless the product contains rice, and “sugar” unless the product is derived from plant-based simple sugar or sucrose.
  • The “Milk Labeling” law cross-references the U.S. Food and Drug Administration’s (FDA’s) standard of identity for milk 21 C.F.R. § 131.110, defining it as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”  The law further specifies that the word “milk” is to be interpreted to include the milk of hooved mammals, such as cows, goat, sheep and water buffalo.
  • The Milk Labeling Law becomes effective on August 1, 2019.  The Truth in Labeling law becomes effective on October 1, 2020, with violators subject to a civil penalty of up to $500 per day per violation.

FDA Authorizes Qualified Health Claim for Foods and Supplements with EPA and DHA Omega-3 Fatty Acids

  • On June 19, 2019, FDA announced that it would not object to qualified health claims for foods and dietary supplements stating that the consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) may reduce the risk of hypertension and coronary heart disease by lowering blood pressure. In a letter of enforcement discretion to The Global Organization for EPA and DHA Omega-3s, FDA stated that—while the overall evidence was inconclusive and inconsistent—there was “credible evidence” to support the qualified health claim.
  • FDA provided five qualified health claims as being consistent with the letter of enforcement discretion, an example of which is, “Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension.  However, FDA has concluded that the evidence is inconsistent and inconclusive.  One serving of [name of the food or dietary supplement] provides [  ] gram(s) of EPA and DHA.”
  • Foods and dietary supplements bearing the health claim must contain a combined total of at least 0.8 g of EPA and DHA per serving and otherwise comply with the general requirements for foods bearing health claims under 21 CFR § 101.14.

FDA Issues Final Guidance on Declaration of Added Sugars for Honey, Maple Syrup, Etc.

  • On June 18, 2019, FDA issued a final guidance to provide clarity on the labeling of added sugars for single-ingredient packages or containers of pure honey, maple syrup and other single ingredient sugars and syrups as a result of a requirement contained in the Agriculture Improvement Act of 2018 (Pub. L. 115-334), known as the “Farm Bill.”  We reported on the draft guidance and comments submitted on the draft guidance here.
  • Single-ingredient products, such as pure honey and maple sugar, are not required to declare the number of grams of added sugars in a serving of the product on the Nutrition Facts label but must still include the percent Daily Value (DV) for added sugars. In the guidance, FDA states its intent to exercise enforcement discretion by permitting the use of the “†” symbol immediately following the added sugars percent DV declaration, which leads to a footnote inside the Nutrition Facts label explaining the amount of added sugars that one serving of the product contributes to the diet as well as the contribution of a serving of the product toward the percent DV for added sugars.
  • With respect to certain dried cranberry products and cranberry beverage products, these products must still declare added sugars in grams and declare the percent Daily Value for added sugars.  However, in the guidance, FDA states it intent to exercise enforcement discretion by allowing the use of a symbol immediately following the added sugars percent Daily Value declaration leading to a statement outside the Nutrition Facts label explaining that sugars are added to improve the palatability of naturally tart cranberries.
  • Overall, FDA is giving manufacturers of single ingredient packages/containers of pure honey, maple syrup, other pure sugars and syrups, and cranberry products enforcement discretion until July 1, 2021 to comply with the new nutrition labeling requirements. FDA states that the extra 6 months is needed to give these manufacturers additional time to make label changes consistent with the Farm Bill and this final guidance.



Executive Order: Eliminate One-Third of Advisory Committees

  • On June 14, President Trump issued an Executive Order on Federal Advisory Committees. The Executive Order (EO) directs executive departments and federal agencies to evaluate their current advisory committees established under section 9(a)(2) of the Federal Advisory Committee Act (FACA). As part of the review, each agency “shall, by September 30, 2019, terminate at least one-third of its current committees.” Although, agencies may request a waiver. The Order also imposes limitations on new Advisory Committees.
  • The EO states that agencies may count committees discontinued since January 20, 2017, towards the termination requirement. This will allow FDA to count the termination of its Food Advisory Committee since that committee was discontinued effective December 12, 2017. (For information on why that committee was discontinued, see our blog, FDA Discontinues Food Advisory Committee.)
  • Reporting requirements are also included in the EO. On or before August 1, 2019, the head of each agency is required to submit to the Director of the Office of Management and Budget: 1) a recommendation on whether each of the agency’s current advisory committees should be continued and 2) a detailed plan for either continuing or terminating each committee.
  • We will report on the impact that this EO will have on FDA’s and USDA’s Food Advisory Committees.

FDA Reiterates That Scientific Data and Safety Information are Required to Support a Regulation or Formal Enforcement Discretion Policy on the Use of CBD in Foods


  • Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Industry wants FDA to create an exception by regulation to the FD&C Act prohibition that currently makes it illegal to add CBD to a food or market CBD as a dietary supplement.  Some would alternatively be satisfied with a formal nonenforcement policy from FDA on the statutory prohibition.
  • At a May 31, 2019 meeting, discussed in this blog, FDA pointed out that it has never issued a regulation to create an exception to the statutory prohibition against the use in food of a substance that has been approved as a drug.  Confirming there is no policy of enforcement discretion with respect to the use of CBD, FDA also remarked on a lack of research to support the safety of CBD for use in food and dietary supplements.  The docket, FDA-2019-N-1482, solicits information on safety (including whether there is a threshold level that could appropriately be considered safe for), manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
  • A June 14, 2019 statement by Dr. Amy Abernethy, FDA’s Principal Associate Commissioner for Policy, reiterates that outstanding questions related to the safety of CBD products must be addressed before a regulatory framework can be established for lawfully marketing foods and dietary supplements containing CBD.  Dr. Abernathy indicated that upon review of the docket (which she indicated may remain open past the current July 2, 2019 deadline for comments), FDA will identify gaps and examine “how additional research can be performed quickly and efficiently to address critical questions about the safety and effectiveness of CBD.”


President Trump Issues Executive Order to Streamline Regulation of Genetically Modified Food

  • On June 11, President Trump issued an Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products.  The purpose of the Executive Order (EO) is to employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment with an ultimate goal of facilitating innovation, ensuring coordination across regulatory agencies (the United States Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA)), and fostering public confidence in the oversight of such products.
  • Six specific policy objectives are listed, with additional elaboration on each:
    • Base regulatory decisions on science and, as appropriate and consistent with law, economic factors;
    • Review applications for products of agricultural biotechnology quickly and efficiently;
    • Ensure transparency, predictability, and consistency in the regulation of products;
    • Involve the public in guidance and regulation development;
    • Use a risk-based decision-making process; and
    • Promote a science- and risk-based regulatory approach with trade partners.
  • The heads of USDA and the Department of Health and Human Services (HHS; the Department in which FDA sits) have issued press releases regarding the EO.  Both Agencies applauded the EO and both indicated that currently ongoing efforts at each Agency would continue in support of the EO.  These ongoing efforts include FDA’s Plant and Animal Biotechnology Innovation Action Plan, Veterinary Innovation Program, and Plant Biotechnology Consultation Program and USDA’s non-regulation of plants that could otherwise have been developed through conventional breeding techniques (consistent with the Bioengineered Food Labeling Rule).
  • The EO’s push for streamlined regulation of genetically modified organisms can be contrasted with recent increases in regulation in Europe.

FDA Releases Statement on PFAS in Food and Reveals Findings from Food Sample Tests

  • On June 11, Acting FDA Commissioner Ned Sharpless released a statement highlighting recent agency efforts to better understand the impact of per- and polyfluoroalkyl substances (PFAS) in food and providing findings from recent tests of food samples in the United States.  In presenting the initial results of the testing, which focused on foods from specific geographic areas with known environmental contamination, Sharpless affirmed that FDA “does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling.”
  • PFAS, which is a catch-all term for a family of human-made substances known for their grease, water, and oil-resistant properties, are widely used in a variety of everyday products such as fabrics, cleaning products, and paints. They are also authorized for a limited number of uses in cookware and certain food packaging applications.  PFAS have been the subject of increased scrutiny among environmental groups and certain states.
  • Of the 91 samples evaluated from the 2017 FDA Total Diet Study (TDS), 14 contained PFAS. The safety assessments undertaken for these 14 samples indicated no human health concern, based on analysis of the level of PFAS found in that food, consumption of that food, and the most current toxicological information available for PFAS.  Sharpless’ announcement comes one week after FDA updated its website to include information on PFAS in the food supply and the agency’s newly formed PFAS working group.  The agency plans to continue to work with states to develop testing methods and capacities and to increase the baseline knowledge of PFAS levels in foods.

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