FDA Issues First Draft Guidance Document on Intentional Adulteration

  • As promised in March 2018, FDA has issued the first of three guidance documents concerning its Final Rules on Mitigation Strategies to Protect Food Against Intentional Adulteration under the Food Safety Modernization Act (FSMA).  These rules are intended to guard against the deliberate adulteration of food by employees.
  • The 94-page guidance provides an overview of key aspects of the regulations (found at 21 C.F.R. Part 121), including preparing a Food Defense Plan (Chapter 1), conducting a vulnerability assessment (Chapter 2), mitigation strategies (Chapter 3), and food defense monitoring (Chapter 4).  It also offers a number of worksheets to assist businesses in complying with the new rules, which become effective for most businesses on July 26, 2019.
  • The second installment is expected to provide more detailed guidance on methods to identify a facility’s most vulnerable points, and the third installment will address corrective actions, verification, reanalysis, and record keeping.  These guidance documents are expected later in 2018.  Commissioner Scott Gottlieb believes that the guidance addresses stakeholder concerns regarding the practicality of the rules and the need for flexibility when conducting vulnerability assessments, but it remains to be seen whether industry agrees.

FDA to Revise Approach to Labeling Some Added Sugars

  • As previously reported on this blog, FDA published a draft guidance in February 2018 to help industry declare added sugars on the label of pure honey, pure maple syrup, and certain cranberry products. More than 3,000 comments were submitted on the draft guidance by the June 15, 2018 deadline. The comments on the draft guidance can be viewed here.  Yesterday, FDA announced that “it plans to take these comments into consideration to swiftly formulate a revised approach that makes key information available to consumers in a workable way.”
  • The draft guidance advised food manufacturers of FDA’s intent to allow manufacturers to use a symbol on the Nutrition Facts label immediately after the added sugars daily value on containers of pure maple syrup and pure honey that directed consumers to language that provides information about “added sugars” and what it means for each of these specific products. An example given in the draft guidance was, “All these sugars are naturally occurring in honey.”  Many of the comments suggested that this approach would not provide the clarity that the FDA intended. Consequently, FDA explained that it plans to work with stakeholders to devise a solution that will allow consumers to effectively use the new Nutrition Facts label to make informed, healthy dietary choices.
  • With respect to cranberry products, industry had expressed concern that the added sugars declaration would be detrimental to the cranberry industry by implying that cranberry products are less nutritious than competitive products that have similar amounts of total sugars and nutrients. In response, FDA explained in the draft guidance that a symbol could be added after the added sugars daily value that directs consumers to a statement such as, “Sugars added to improve the palatability of naturally tart cranberries.”
  • We will continue to report on FDA’s progress in revising the approach for listing added sugars on the labels of honey, maple syrup, and cranberry products, along with other developments concerning the new nutritional labeling requirements.

California Coffee May No Longer Require Cancer Warnings

  • On June 15, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed a new regulation clarifying that cancer warnings are not required for coffee under Proposition 65. Proposition 65 is a right-to-know law that requires businesses to provide warnings when they knowingly cause exposures to chemicals that the state has listed as causing cancer or reproductive harm. However, the statute does not require cancer warnings when exposure to listed chemicals does not cause a significant cancer risk.
  • OEHHA’s proposed regulation states that drinking coffee does not pose a significant cancer risk, despite the presence of acrylamide created during the roasting and brewing process. OEHHA’s proposed regulation is based on extensive scientific evidence that drinking coffee has not been shown to increase the risk of cancer and may reduce the risk of some types of cancer. For example, the World Health Organization’s International Agency for Research on Cancer (IARC) concluded that there is “inadequate evidence” that drinking coffee causes cancer. IARC found that coffee is associated with reduced risk for cancers of the liver and uterus, and does not cause cancers of the breast, pancreas and prostate.
  • This proposed regulation is in direct contrast to the March court ruling previously discussed on this blog. In Council for Education and Research on Toxics (CERT) v. Starbucks, et al., Los Angeles Superior Judge Elihu Berle ruled that sellers of coffee must display cancer warnings because coffee contains acrylamide, which is listed as a carcinogen under Proposition 65. OEHHA’s proposed regulation may lead to calls for a reevaluation of studies on the cancer implications of acrylamide in other foods, like baked goods.
  • Public comment on the proposed regulation will be accepted until August 30, 2018.  Additionally, OEHHA will hold a public hearing on August 16. Interested parties with questions regarding the upcoming meeting or who would like assistance in preparing comments are encouraged to email us at fooddrug@khlaw.com.

FDA Announces July 12, 2018 Public Meeting on Foods Produced Using Animal Cell Culture Technology


  • Cultured meat has been an increasingly hot topic since the first “clean meat” hamburger was introduced in London in 2013.  The technology involves using cell culturing techniques to multiply a small amount of cells taken from an animal to produce foods that resemble traditional meat, poultry, and seafood.  As commercial-scale production of cultured meat becomes foreseeable, regulatory agencies must determine how these products fit into their food compliance programs.


  • Today, FDA published notice of a public meeting 83 Fed. Reg. 28238 to discuss safety-related data and information that FDA is seeking on foods produced using animal cell culture techniques.  The public meeting will be held on July 12, 2018, from 8:30 a.m. until 3 p.m. EST.  Naming of such foods (which we have covered on this blog) will not be a focus of the upcoming meeting.  Meeting topics will include:


    • What considerations specific to animal cell culture technology would be appropriate to include in evaluation of food produced by this method of manufacture?
    • What kinds of variations in manufacturing methods would be relevant to safety for foods produced by animal cell culture technology?
    • What kinds of substances would be used in the manufacture of foods produced using animal cell culture technology and what considerations would be appropriate in evaluating the safety of these uses?
    • Are the hazards associated with production of foods using animal cell culture technology different from those associated with traditional food production/processing (such as, for example, insanitary conditions, improper temperature controls, or control of contaminants)?
    • Is there a need for unique control measures to address the hazards associated with production of foods using animal cell culture technology?


  • Comments for consideration by FDA in regulating the safety of foods produced using animal cell culture techniques are due by September 25, 2018.  Interested parties with any questions regarding the upcoming meeting or who would like assistance in preparing comments are encouraged to email us at fooddrug@khlaw.com.

FDA Releases Guidance on Dietary Fiber

  • Today, June 15, 2018, FDA published in the Federal Register a notice that it has issued “Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels”.  This direct-to-final guidance provides additional clarity on which isolated and synthetic non-digestible carbohydrates (NDCs) will be recognized by FDA as fiber for nutrition labeling purposes.  In the May 27, 2016 final nutrition labeling rule, FDA identified seven NDCs that may be declared as dietary fiber.  They are:
    • [beta]-glucan soluble fiber (as described in 21 CFR § 101.81(c)(2)(ii)(A));
    • Psyllium husk (as described in 21 CFR § 101.81(c)(2)(ii)(B));
    • Cellulose;
    • Guar gum;
    • Pectin;
    • Locust bean gum; and
    • Hydroxypropylmethylcelluylose.
  • Today’s guidance and a supporting science review identified an additional eight NDCs that FDA intends to propose adding to the regulation as dietary fiber.  FDA also announced that they will exercise enforcement discretion regarding the declaration of dietary fiber for these NDCs pending the completion of rulemaking to revise 21 CFR 101.9,  provided a caloric value of 1 kcal/g for polydextrose, and provided clarity on recordkeeping requirements.  The eight newly identified NDCs are:
    • Mixed plant cell wall fibers;
    • Arabinoxylan;
    • Alginate;
    • Inulin and inulin-type fructans;
    • High amylose starch (resistant starch 2);
    • Galactooligosaccharide;
    • Polydextrose; and
    • Resistant maltodextrin/dextrin.

Mixed plant cell wall fibers are a general category of isolated NDCs.  Mixed plant cell wall fiber ingredients contain two or more of the following plant cell wall fibers in varying proportions: cellulose; pectin; lignin; beta-glucan; and arabinoxylan. The Scientific Review further elaborates on Mixed plant cell wall fibers and includes the following list of examples:  “apple fibers, bamboo fibers, barley fibers, carrot fibers, citrus fibers, cocoa fibers, corn fibers (e.g., corn hull fiber), cotton seed fibers, oat fibers (e.g., oat hull fiber), pea fibers (e.g., pea hull fiber, pea seed coat fiber, inner cotyledon pea fiber), rice bran fibers, soy fibers (e.g., soy hull fiber, soy polysaccharide, soy cotyledon fiber), sugar beet fibers, sugar cane fibers, and wheat fibers.”  The guidance also provides further information on FDA’s position regarding “intrinsic and intact.”

  • FDA also responded to five citizen petitions requesting that additional NDCs be added to the definition of “dietary fiber.”  Two responses were granting fiber status to resistant dextrin/maltodextrin, one response was to grant fiber status to inulin, one response denied fiber status to isomaltooligosaccharides (IMOs), and the last one was indicating that FDA will continue to review the citizen petition for Modified Wheat Starch, Resistant Starch 4. Several citizen petitions for determination that NDCs qualify as dietary fiber are still pending with FDA.  Additionally, FDA will review new citizen petitions for a determination on a rolling basis.
  • Keller and Heckman is preparing a more detailed review of the guidance that will be available soon, and stands ready to assist food manufacturers who wish to seek expansion of the current list of substances considered by the agency to fall within the definition of dietary fiber.

FDA Releases Guidance on Evaluating Animal Drug Safety in Food-Producing Animals

  • FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry #3:  General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals) describing the types of information that the Center expect to see when such drugs are used in food-producing animals.
  • Under Section 512(b)(1) of the Federal Food, Drug and Cosmetic Act, sponsors of new animal drugs are required to demonstrate the safety in edible tissues.  The guidance addresses topics including:
    • Determining an acceptable daily intake (ADI);
    • Calculating safe concentrations;
    • Assignment of a tolerance;
    • Calculation of a withdrawal period and a milk discard time; and
    • Evaluation of carcinogenic compounds

This general guidance provides references to other CVM guidance documents that provide more detailed information on specific topics, such as conducting specific types of toxicity testing to evaluate residues of veterinary drugs (e.g., Guidance for Industry #116: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing).

  • Importantly, the guidance acknowledges that it is designed to address “traditional” new animal drugs that consist of small molecules and that it may not be applicable to evaluating the safety of “non-traditional” new animal drugs (e.g., biotechnology-derived new animal drugs, including some enzymes, fusion proteins, synthetic hormones, and antibodies).  In these latter cases, CVM may be willing to consider alternative approaches to address toxicological concerns.  In those cases, CVM recommends that the sponsor contact CVM early in the drug development process to develop studies to address toxicological concerns.

Senate Released Bipartisan Draft of Farm Bill

  • As previously reported on this blog, in March 2018, House Agricultural Committee Chairman Michael Conway delayed the release of the draft law renewing farm and nutrition programs due to opposition to cuts to the Supplemental Nutrition Assistance Program (SNAP). SNAP offers nutrition assistance to more than 47 million eligible, low-income individuals and families, and is authorized and subsidized by the farm bill. However on May 18, 2018, the U.S. House of Representatives voted down its version of the farm bill.
  • The Senate released its bipartisan draft of the farm bill on June 8, 2018. The bill, titled the Agricultural Improvement Act of 2018, is largely a continuation of the current farm bill, which passed in 2014. The Senate’s draft bill takes a more conventional approach than the House version, and does not include the same controversial work requirements for SNAP that appeared in the House’s proposal.
  • Other notable provisions in the Senate bill include:
    • Re-authorization of the Farm and Ranch Stress Assistance Network (FRSAN), which is a mental health resources program established by the 2008 farm bill, but never funded. This provision allocates $10 million through 2023 and requires USDA to report to Congress on the state of mental health in farming communities.
    • Funding for the Organic Certification Cost Share Program (which reimburses producers who apply for organic certification) and the Organic Agriculture Research and Extension Initiative (which funds projects for organics research and development).
    • Modernize the Food for Peace program, which provides nutritional assistance around the world.
    • Legalize hemp as an agricultural product and make the plant eligible for crop insurance.
    • Bring back the position of Under Secretary for Rural Development at the USDA, which Secretary Sonny Perdue eliminated in 2017.
  • The bipartisan bill is likely to pass in some form. The Senate Agricultural Committee will vote on the bill today, June 13, 2018.

Bipartisan Bill Would Protect State Marijuana Laws

  • Several U.S. Senators introduced a bipartisan bill titled, Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act), on June 7. The bill would allow states, U.S. territories, and federally recognized tribes to choose how to regulate the use of marijuana within the borders of their state without federal interference. However, the bill would leave certain provision of the federal Controlled Substances Act in place. These include prohibiting the endangerment of human life during marijuana manufacturing and the distribution of marijuana at rest areas and truck stops.
  • The bill was introduced by Senators Elizabeth Warren (D-Mass.) and Cory Gardner (R-Colo.) and Representatives David Joyce (R-Ohio) and Earl Blumenauer (D-Ore.) who indicated that forty-six states have already passed laws permitting or decriminalizing marijuana or marijuana-based products.
  • The STATES Act also amends the definition of “marijuana” under the Controlled Substances Act to specifically exclude industrial hump. (Marijuana and industrial hemp come from the same genus of flowering plant cannabis, but industrial hump has a very low concentration of the psychoactive chemical, tetrahydrocannabinol (THC), while marijuana plants contain a high level.) The governor of Colorado recently signed a bill into law that stipulates that food and cosmetics are not adulterated or misbranded for containing industrial hump and applies existing food manufacturing guidelines to food products containing industrial hemp.
  • Many states were concerned after Attorney General Jeff Session announced in January that he was ending a policy from the Obama-era that banned the U.S. Department of Justice from spending money to interfere with the implementation of state medical marijuana laws. Furthermore, as previously stated in this blog, FDA has implied that it may start to investigate some marijuana health claims and benefits. Since Sessions’ announcement, though, several marijuana-related bills have been introduced in Congress, however, a Medill News Service article points out that the STATES Act seems more likely to pass due to is emphasis on states’ rights.

FDA Again Targets Bulk Quantities of Pure or Highly Concentrated Caffeine Sold to Consumers as Dietary Supplements


  • As previously reported on this blog, FDA sent Warning Letters to five companies that distributed pure powdered caffeine in 2015 and advised that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.”  FDA stated in the letters 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.
  • FDA has recently made public two additional Warning Letters involving bulk forms of dietary supplements with pure or highly concentrated caffeine.  FDA’s May 29, 2018 Warning Letters, to the sellers of Caffeine Anhydrous Powder, a pure caffeine powder sold in bulk to consumers, and the sellers of Liquid Caffeine, a highly concentrated liquid form of caffeine sold in bulk to consumers, note potential difficulties for consumers in accurately measuring a safe dose of these products.  Liquid Caffeine is the first liquid caffeine dietary supplement to be targeted by FDA.  FDA’s letter on Liquid Caffeine states:

In light of the potential toxicity of your product; the fact that your product is packaged to contain an amount that would be toxic several times over, and potentially lethal to certain consumers; the fact that the packaging requires the consumer to separate out a safe serving from this potentially toxic amount; the fact that the product labeling incorrectly implies that this process of separating out a safe serving from a potentially toxic amount can be done with a pump, which is not in fact sold with the product; and the fact that the product is instead co-packaged with a measuring device that holds 6 “one-pump” servings of your product, but is labeled with a different unit of measurement from the directions, such that consumers might not understand how many servings it contains and assume that it contains one serving; we have determined that your product presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.

  • FDA’s continuing actions against bulk quantities of dietary supplements with pure or highly concentrated caffeine show that the Agency considers potential overdosing with caffeine to be a very serious risk for these products.


FDA and CDC Release Results of 2017 National Youth Tobacco Survey

  • On June 7, FDA and CDC released the results of the 2017 National Youth Tobacco Survey.  Total number of high- and middle-school tobacco users of any tobacco product continued to fall to unprecedented levels, dropping over 20% between 2011 and 2017, from approximately 4.56 million to 3.62 million youth users.  Comparing tobacco use as a percentage of population, use amongst high-school students dropped from 1 in 4 in 2011 to 1 in 5 in 2017 and from 1 in 13 middle-school students in 2011 to 1 in 18 middle-schoolers in 2017.  The positive results continue to make clear that any fear of a “gateway” effect to smoking from use of reduced harm products like e-cigarettes is, so far, unfounded. While acknowledging the reduction, both CDC and FDA are actively seeking further reduction in youth tobacco use, and highlight concerns over youth e-cigarette use and nicotine addiction.
  • FDA took the opportunity of the release of the Survey results to reiterate and expand upon its Youth Tobacco Prevention Plan.  FDA has taken steps, including warning letters, requests for information, advertising campaigns, focus groups with youth, youth use surveys, and further regulation to limit youth use.  FDA also acknowledged, once again, that e-cigarettes “may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them.”
  • You can read more about FDA’s regulation of tobacco, including the 2017 National Youth Tobacco Survey, from Keller and Heckman’s Tobacco and Vapor Practice on its blog, The Continuum of Risk, including and as guest authors on Law360 (subscription required).

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