Incredible Edible Food Packaging

USDA researchers are developing edible food packaging made from milk proteins.

  • Fomented by dual considerations of food safety and consumer tastes, the food packaging industry is continuously seeking to develop cutting-edge packaging materials designed to capture consumer attention and increase market share.
  • The American Chemical Society reports that U.S. Department of Agriculture researchers are developing edible, biodegradable packaging film derived from a milk protein called casein.  The researchers claim that this casein-based film could be more effective than current edible packaging materials and appears to protect food products that are sensitive to light.  A key potential application of this new film may involve serving as an immediate wrapper for cheese products (which, in turn, would be housed in a larger plastic container).  Science Daily reports that some manufacturers could also consider “spray on” casein-protein coatings to line the interior of pizza and food boxes to keep grease from staining the packaging, or to serve as a lamination step for paper or cardboard food boxes or plastic pouches.
  • Given the early stage of development of this new film technology, it remains to be seen if, and to what extent, casein-based films will show up on a grocery shelf near you, and the potential regulatory issues that might be presented by such films.

“Natural” and “Organic” Growth

The continued uptick in “Natural” and “Organic” claims combined with increased consumer confusion concerns may result in new and strengthened federal regulations. (subscription to Bloomberg BNA required)

  • Foods sporting “natural” and “organic” claims are on the rise in response to increasing consumer demand for cleaner, “healthier” foods.  The growth in “natural” foods, in particular, continues despite the lack of a codified federal definition of “natural”, and the regulatory and litigation risk faced by food companies stemming therefrom.  Federal regulators are well aware of the issues confronting industry on the “natural” front and, as previously covered on this blog, the U.S. Food and Drug Administration (FDA) is considering whether the term “natural” should be regulated.  To this end, late last year, FDA formally requested information and public comment on the use of the term “natural” in food labeling.
  • While industry awaits FDA’s potential regulation of the term “natural”, Bloomberg reports that one recent survey conducted by the U.S. Federal Trade Commission (FTC) and the U.S. Department of Agriculture (USDA) indicates consumers are conflating the terms “natural” and “organic” (a USDA-regulated term).  This comes as the number of consumer class actions involving “natural” food marketing claims steadily increase.
  • Continued consumer confusion concerns surrounding the use of “natural” and “organic” advertising claims could lead regulators to propose new and strengthened guidelines for employing these terms in food industry advertising.

FDA Issues Additional FSMA Draft Guidance Documents for Animal Foods and the Classification of Activities for Farms and Facilities

FDA has issued two draft guidance documents to assist industry with the implementation of Preventive Controls and Current Good Manufacturing Practices under the Animal Food Rule and another draft guidance to assist businesses in determining whether the activities they perform are within the “farm” definition.

  • The two Draft Guidance documents relating to the Animal Food Rule include:
  • The Draft Guidance pertaining to the classification of activities for farms and facilities, available here, is intended to assist businesses determine whether the activities they perform are within the “farm” definition.  In general, businesses that only perform activities within the “farm” definition are not subject to the FSMA Preventive Controls for Human Food or Animal Food rules.  Rather, activities involving covered produce may be subject to the FSMA Produce Safety rule instead.
  • All three draft guidance documents are available for public comment starting today, August 25, 2016.

FDA Delays Certain FSMA Compliance Dates and Issues Draft Guidance on Preventive Controls for Human Food

FDA issues HARPC Draft Guidance and delays compliance dates for several key FSMA provisions.

  • FDA issued a final rule today that extends and clarifies the compliance dates for certain provisions in four of the foundational rules implementing the Food Safety Modernization Act (FSMA).  These changes are intended to address concerns about the practicality of compliance with certain provisions, better align compliance dates across the rules, and address technical issues.
  • The implicated rules are: (1) Preventive Controls for Human Food Rule, (2) Preventive Controls for Food for Animals Rule, (3) Produce Safety Rule, and (4) Foreign Supplier Verification Programs (FSVP) Rule.
  • Highlights of the final rule include:
    • extending the compliance dates with respect to “customer provisions” that apply when a manufacturer/processor identifies a hazard requiring a preventive control, does not control the identified hazard, and relies on an entity in its distribution chain to address the hazard; the earliest compliance date is September 19, 2018.
    • additional time for importers of food contact substances to comply with the FSVP rule; the earliest compliance date is May 28, 2019.
    • additional time for facilities that are covered by the two Preventive Controls rules for human and animal food (including CGMPs), and are solely engaged in packing and/or holding produce raw agricultural commodities; compliance dates for these entities are extended to align with the Produce Safety Rule.
  • For a detailed summary of the final rule extending compliance dates, please feel free to contact us at:
  • Finally, FDA has also published a Draft Guidance concerning Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food.  The Draft Guidance, which is available for public comment starting today, August 24, 2016, explains FDA’s current thinking on how to comply with certain of the requirements for hazard analysis and risk-based preventive controls and specifically addresses how food producers should go about developing an appropriate food safety plan.  The deadline for comments is February 21, 2017.
  • Keller and Heckman is currently working on a detailed summary of the Draft Guidance.  In the meantime, interested parties may contact us for a copy of the summary and may email us at with any questions regarding the implications of FDA’s Draft Guidance.



USDA Issues Guidance Greenlighting “Non-GMO” Claims

On the heels of the recently enacted federal GMO labeling law, USDA has released guidance for labeling meat, poultry and egg products as “Non-GMO”.  

  • “Non-GMO” claims — i.e., claims advertising the non-use of genetic modification (GM) in food production — have become increasingly popular and desirable from a marketing standpoint.  Until now, no clear regulatory definition or oversight of such claims existed.  Effective immediately, however, USDA’s Food Safety & Inspection Service (FSIS) will begin approving “Non-GMO” claims for meat, poultry and egg products that do not contain bioengineered ingredients or that are derived from livestock that do not consume bioengineered feed.  This new Agency policy stems directly from the passage of the new federal GMO labeling law which mandates USDA to develop and implement a national bioengineered food disclosure standard within 2 years.
  • To facilitate Agency approval of “Non-GMO” claims, USDA’s FSIS has released a compliance guide for companies that seek to make label or labeling claims concerning the fact that bioengineered or GM ingredients were not used in a meat, poultry or egg product.  This guidance document also provides information on how companies can make label or labeling claims that a product was produced from livestock or poultry that were not fed bioengineered or GM feed.  Of note, the FSIS compliance guide adopts the definition of “bioengineering” from the federal GMO labeling law, where the term “bioengineering refers to a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”
  • The issuance of this guidance document represents the first substantial Agency action in connection with the implementation of the new federal GMO labeling law, and provides some insight into how USDA will approach “Non-GMO” claims for foods regulated by FDA as opposed to USDA.  USDA will be accepting comments on this industry guidance for 60 days following its imminent publication in the Federal Register.

Scaling Back Sodium – FDA Extends Comments Period for Draft Guidance

FDA has extended the comments period for its draft guidance regarding sodium reduction in food.

  • As previously covered on this blog, on June 1, 2016, FDA issued a draft guidance document that provides voluntary sodium reduction targets for the food industry, specifically aimed at food manufacturers, restaurants, and food service operators.  The draft guidance sets forth a 2-year goal of reducing intake to 3,000 mg per day and a 10-year goal of reducing intake to 2,300 mg per day.
  • Late last week, on August 18, 2016, FDA announced an extension of the comments period for its draft guidance.  The comment period for 2-year sodium reduction targets is now October 17, 2016 (instead of August 31, 2016).  The comment period for the 10-year targets is now December 2, 2016 (instead of October 31, 2016).
  • FDA is granting the extension in response to requests from industry trade associations, as well as consumer and public health organizations.  Keller and Heckman attorneys stand ready to assist interested parties in preparing comments and can be reached at:

Carrageenan Study Calms Concerns

The use of carrageenan as a food ingredient has been the source of some concern in recent years based on inferences drawn from studies conducted on human cell cultures.

  • Carrageenan is an ingredient obtained from seaweed that is used widely in foods and beverages to perform gelling, thickening, and stabilizing functions.  Although many long-term studies support the safety of carrageenan consumption, concerns have been raised in recent years regarding its potential to cause gastrointestinal inflammation.  In 2012, the FDA rejected a petition seeking to ban the use of carrageenan in food, effectively validating the safety of the ingredient.  Further, in 2015, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded that the use of carrageenan in infant formula is “not of concern” at levels of up to 1,000 mg per liter (see our previous blog coverage on the JECFA findings here).
  • A recent study led by internationally recognized toxicologist and carrageenan expert Dr. James M. McKim, Jr. lends further support to the safety of carrageenan, finding that carrageenan did not induce inflammation in human cells as claimed by carrageenan critics.
  • This recent study should enlighten any continued debate about the safety of carrageenan.

Cage-Free Kerfuffle

Massachusetts has proposed legislation restricting the sale of eggs to the “cage-free” variety. (subscription to Food Chemical News required)

  • With consumers’ increasing appetite for more ethical food options, a number of food manufacturers are now marketing “cage-free” eggs.
  • States are getting in on the cage-free action as well.  For example, earlier this summer, the Massachusetts Supreme Court approved a ballot initiative proposing that Massachusetts farms and businesses produce and sell only eggs from cage-free hen; the sale of eggs from caged hen would be effectively prohibited under this measure which will be up for a vote this November.  The National Association of Egg Farmers pushed back, citing research that cage-free production does not necessarily lead to “better welfare” outcomes for the birds.
  • It remains to be seen the extent to which consumers’ continuing shift toward ethically-minded foods will result in additional legislative and regulatory efforts along the lines of the upcoming Massachusetts ballot initiative.


Fishy Business: Organic Aquaculture Rule Flounders at OMB

Industry awaits USDA’s Proposed Organic Aquaculture Rule which has been undergoing OMB review for the past year.

  • Today marks one year since USDA sent its proposed organic aquaculture standards to the White House Office of Management and Budget (OMB) for review.  If and when this rule is released and finalized, the rule will set the first ever U.S. standards for the cultivation and production of organic fish and other seafood.  Europe and Canada already have organic aquaculture standards in place.
  • With health-conscious consumers trending towards “organic” foods, and industry eager to capitalize on the premium paid for goods sporting the USDA organic seal, many food industry experts expect organic aquaculture standards to become law in the U.S. in the very near future.  It remains to be seen, however, just how far the Agency will go with respect to implementation and monitoring of any such standards.
  • While industry awaits the proposed rule, some U.S. retailers are marketing organic seafood if the product was certified organic by an appropriate foreign certification body (except in the state of California where the sale of organically labeled seafood is currently prohibited).

Counting Calories – FDA Issues Draft Guidance for Labeling Vending Machine Foods

FDA Issues Draft Guidance and Small Entity Compliance Guide Regarding Calorie Labeling For Vending Machine Foods

  • On December 1, 2014, FDA issued a final rule (79 FR 71259) entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines”.  The rule implements the vending machine labeling provisions of the Affordable Care Act that require disclosure of calorie information at the point of purchase for food sold by persons who own or operate 20 or more vending machines.
  • The Draft Guidance and corresponding Small Entity Compliance Guide (SECG), published today, provide additional information to support compliance with the final rule and responds to frequently asked questions about the vending machine labeling requirements, including, but not limited to, covered operators, calorie declaration, calorie display, and compliance.
  • With specific regard to the timeline for compliance, vending machine operators subject to the final rule have until December 1, 2016, to comply with the rule, which is 2 years after the date of the final rule’s publication in the Federal Register.  As previously covered on this blog, however, in the Federal Register of August 1, 2016 (81 FR 50303), the Agency issued a final rule entitled “Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date.”  This rule provides that the compliance date for type size front-of-pack labeling requirements and calorie disclosure requirements for certain gums, mints, and roll candy products in glass-front machines in the final rule published December 1, 2014 is extended to July 26, 2018.  The compliance date for all other requirements in the final rule remains December 1, 2016.
  • The Agency is currently accepting comments on both the Draft Guidance, as well as the SECG.  Comments submitted on the Draft Guidance within the next 45 days will bear directly on the final version of the Guidance.  Keller and Heckman attorneys would be happy to assist interested parties with preparing comments for submission to the Agency, and can be reached at: