FDA issues order to stop further sale and distribution of four cigarette products.

  • As highlighted recently on this blog, FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act).  During a provisional period established by the Tobacco Control Act, companies were permitted to continue marketing tobacco products that are “substantially equivalent” to valid predicate products (i.e., products that were commercially marketed as of the February 15, 2007 Grandfather Date).  Companies were required to submit “Provisional” Substantial Equivalence (SE) Reports to FDA by March 22, 2011 to justify continued marketing of products that were already on the market, but not grandfathered.  Tobacco products subject to Provisional SE Reports are allowed to remain on the market pending FDA’s review and unless the Agency issues a not substantially equivalent (NSE) order.
  • On September 15, 2015, FDA issued orders to stop further U.S. sale and distribution of four R.J. Reynolds Tobacco Company cigarette products.  FDA evaluated the company’s SE applications and found that Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol, and Vantage Tech 13 cigarettes were NSE to their respective predicate products.  The Agency concluded that the products have “different characteristics than the predicate products and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to them.”
  • When FDA issues an NSE order, the tobacco product subject to the order becomes adulterated and misbranded; thus, further marketing or distribution is prohibited.  FDA has stated that it will not take enforcement action against retailers for 30 days to give them sufficient time to dispose of current inventory.  FDA’s NSE orders mark the first time that the Agency has ordered a company to pull a major brand off the market and serves as a reminder to the tobacco industry of FDA’s significant authorities under the Tobacco Control Act.

Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice and will be hosting a pre-conference seminar on these topics in conjunction with our upcoming Food Packaging Law Seminar.  For more information and to RSVP to these events, click here.

For more information about our tobacco & e-vapor regulatory practice in general, click here.

Researchers engineer plants to produce antimicrobial proteins for potential application in E. coli reduction.

  • Genetic engineering or genetic modification (GM) refers to the use of a host of technologies to manipulate an organism’s genetic code.  In the food industry, GM technology frequently is used to develop crops that express particular traits that are beneficial to food safety and quality (e.g., pesticide resistance, resistance to bruising).
  • A group of scientists recently published a study detailing the development of GM crops that will express antimicrobial proteins (called colicins) that can be applied to food products to kill E. coli bacteria.  The GM plants reportedly can yield high levels of active colicins that promise to be extremely effective at killing all major disease-causing strains of E. coli.  The scientists developing this technology have indicated that since colicins already exist in the human gut, clearance by a Generally Recognized as Safe (GRAS) Notification should be possible in the U.S.  The scientists make no reference to the fact that a pesticide registration will be required for use on raw agricultural commodities (RACs) and that such registration would be limited to use on RACs in a food processing establishment (or en route thereto) unless a regulatory tolerance or exemption from tolerance was established.
  • Concerns about GM technology and foodborne illness persist as topics of interest and debate in the food industry at large, but these areas do not frequently intersect or overlap.  It remains to be seen whether this innovative technology will be well-received by FDA (as its novelty may make GRAS status challenging to establish); the food industry (as this technology does not target other microbial contaminants of concern); and consumers (who already express widely divergent views regarding the safety and desirability of GM foods).

Don’t miss out:  Keller and Heckman is hosting an intensive one-day seminar in New York City on September 24, 2015 to discuss food authenticity issues, particularly with respect to Extra Virgin Olive Oil.  Event details and registration information are available here.

FDA issues draft menu labeling guidance.

  • On December 1, 2014, FDA published a final rule to implement the menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Affordable Care Act.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items.  Although the menu labeling requirements originally were scheduled to take effect on December 1, 2015, FDA recently extended the compliance date to December 1, 2016.
  • On September 11, 2015, FDA issued a draft guidance document intended to assist restaurants and retail establishments with complying with the menu labeling requirements.  The 53-page document provides instructive examples in a Q&A format to clarify the rule’s applicability and flexibility.
  • Regarding compliance and enforcement, the failure to declare accurate calorie and other nutrition information in accordance with FDA’s requirements will result in foods being considered misbranded under the FD&C Act.  FDA is responsible for enforcing the menu labeling requirements, but state governments could enforce them under certain circumstances.  Also, states or localities may establish and enforce menu labeling requirements that are identical to the federal requirements.  FDA has indicated its intent to work with state and local authorities to coordinate implementation and enforcement.  Covered establishments should familiarize themselves with applicable requirements and develop appropriate compliance strategies.

Upcoming Seminar — spaces still available:  Keller and Heckman is hosting an intensive one-day seminar in New York City on September 24, 2015 to discuss food authenticity issues, particularly with respect to Extra Virgin Olive Oil.  Event details and registration information are available here.

New York City adopts sodium warning requirement for chain restaurants.

  • As previously covered on this blog, New York City’s (NYC) Department of Health proposed to require chain restaurants to add a sodium warning to menus and menu boards next to items containing more than the recommended daily intake of 2,300 mg of sodium.
  • On September 9, 2015, NYC health officials voted unanimously to adopt the nation’s first sodium warning requirement.  The rule will apply to all restaurants that are part of chains with more than 15 locations nationwide.  Restaurants will be required to display a salt shaker icon on menus and menu boards next to any food item — whether a standard menu item or a combination meal — with a high sodium content (>2,300 mg of sodium) or on tags next to any food on display that is a food item with a high sodium content.  Restaurants also must post the following statement conspicuously at the point of purchase:  “Warning: [salt shaker icon] indicates that the sodium (salt) content of this item is higher than the total daily recommended limit (2300 mg).  High sodium intake can increase blood pressure and risk of heart disease and stroke.”  The rule takes effect on December 1, 2015, and violations will incur a penalty of $200.
  • As anticipated, the final rule is being met with praise from consumer health advocates and criticism by restaurateurs and salt producers.  Implementing the rule will pose logistical challenges for restaurants, particularly in light of the relatively tight compliance time frame.  Also, despite NYC officials’ position that the sodium warning is a “warning label” and not nutrition information, the rule ultimately could be preempted by federal menu labeling regulations.

FDA issues long-awaited final rules to implement FSMA HARPC provisions for human and animal food.

FDA has issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA).  The rules are scheduled for publication in the Federal Register on September 17, 2015, and the general compliance date for both rules is in September 2016.

  • Click here for FDA’s overview of the final human HARPC rule and here for the full text of the final rule (pre-publication version).
  • Click here for FDA’s overview of the final animal HARPC rule and here for the full text of the final rule (pre-publication version).

Keller and Heckman LLP is preparing full analyses of both final rules and will host a complimentary webinar in the near future to summarize the implications of these rules for the food industry, focusing on both food processors and ingredient suppliers.

Market research firm reports on “free from” trend in snack foods.

  • For years, the food industry has been looking for ways to eliminate or reduce the production of foods that contain ingredients associated with negative consumer perception.  In recent examples, a nationwide restaurant chain promoted a “GM-free” and additive reduction campaign; a major food processor pledged to remove artificial colors and preservatives from its flagship product; and leading cereal producers promised to remove artificial ingredients from their cereals.
  • A leading market research firm now reports that “free from” claims are poised to become an industry standard in the snack food marketplace.  The firm reports that 23% of new snack products launched in 2014 claimed to have no additives or preservatives; 25% said they had low, no, or reduced allergens; and 21% claimed low, no, or reduced trans fat.
  • It comes as no surprise that consumers continue to seek more health and “purity” in the food supply, and consumer perception and spending will continue to drive marketing claims for food products.  As companies continue to work with their supply chains to support claims such as “free from” or “no artificial…,” they must exercise caution to insulate themselves from the risk of challenge from competitors and plaintiffs’ class action lawyers.

Almond Board of California validates a new chemical-free process to pasteurize almonds.

  • Since 2007, the Almond Board of California (ABC) has enforced an industry-wide pasteurization program intended to reduce the presence of Salmonella bacteria in almonds prior to shipment.  Approved pasteurization methods include traditional processes (oil roasting, dry roasting, blanching); steam processing; and the use of propylene oxide (PPO).
  • Recently, ABC’s Technical Expert Review Panel (TERP) validated a new chemical-free pasteurization process that uses radio waves to eliminate pathogens, insects, and mold on food products.
  • Particularly since nearly all almonds are subject to the pasteurization requirement, the development and validation of new pathogen reduction technology will likely be welcomed by the industry.

States support Vermont’s position in GM labeling lawsuit.

  • As previously covered on this blog, the lawsuit brought by the Grocery Manufacturers Association (GMA) and other trade associations to challenge Vermont’s labeling mandate for Genetically Modified (GM) food products is ongoing.  Following the Vermont district court’s denial in April of the plaintiffs’ motion for a preliminary injunction, GMA filed an appeal in the Second Circuit Court of Appeals, arguing that the constitutionality of the law must be analyzed under Central Hudson‘s intermediate standard of scrutiny.
  • Eight states — Connecticut, Maine, Maryland, Massachusetts, Hawaii, Illinois, New Hampshire, and Washington — have filed an amicus brief in the Second Circuit to support Vermont’s position in the litigation.  In their brief, the states argue that the lesser “reasonable basis” standard from Zauderer should be used to evaluate mandatory commercial disclosure laws under the First Amendment, citing parallels to other courts’ application of that standard in cases involving constitutional challenges to mercury labeling, calorie disclosure, and country of origin labeling requirements.  The Zauderer standard applies to “purely factual and uncontroversial disclosures,” and the parties in this case clash over whether GM labeling information may be characterized as such.
  • The level of scrutiny to be applied is a pivotal factor in the outcome of this case and the food industry trade associations are likely to lose if the Zauderer “reasonable basis” standard is applied, which is why they are advocating for the application of Central Hudson‘s intermediate standard.  The Second Circuit reportedly will hear oral arguments by Fall 2015, with a decision due by the end of the year.  Depending on the decision and on Congressional action (or inaction) on federal GM labeling legislation, the food industry may continue to wait for resolution of this issue as the law’s July 1, 2016 implementation date draws nearer.

More than 60 food industry trade associations write HHS and OMB to oppose FSMA-related user fees.

  • Since the enactment of the FDA Food Safety Modernization Act (FSMA) in 2011, many stakeholders have questioned how FDA will get the additional funding its needs to implement the law’s significant new obligations.  The option of industry-paid user fees continues to be a topic of discussion, even though Congress repeatedly has declined to authorize such fees in the past.
  • A coalition of more than 60 food industry trade associations has sent a letter to the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB), requesting that the administration seek all additional funding required for FSMA implementation through the Congressional budget and appropriations process, rather than asking Congress to authorize user fees.  The letter indicates that the creation of “new food taxes or regulatory fees” necessarily will increase the costs of food production and drive up retail prices for consumers.
  • Although Congress repeatedly has declined to authorize FSMA-related user fees, FDA continues to face annual funding shortfalls that leave the Agency unable to meet all its goals under FSMA.  As the food industry prepares for the imminent release of significant FSMA rules, the issue of Agency funding and FDA’s ability to implement new FSMA requirements is likely to remain an active topic of discussion and debate.

FDA issues Warning Letters to five distributors of powdered caffeine alleging safety risks inherent to product use.

  • FDA regulates the marketing of dietary supplements.  Under Section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a supplement is adulterated when it “presents a significant or unreasonable risk of illness or injury under…conditions of use recommended or suggested in labeling.”
  • FDA has issued Warning Letters to five companies distributing pure powdered caffeine and has posted a Constituent Update on its website to warn consumers about the dangers associated with the use of this product.  According to the Warning Letters, FDA has concluded that pure powdered caffeine is adulterated based on the potential toxicity of the product; the fact that the products are “packaged to contain an amount that would be lethal to many consumers”; and the fact that consumers would need to measure the product very precisely to “separate out a safe serving from [the] lethal amount.”  According to FDA’s Constituent Update, one teaspoon of pure powdered caffeine is equivalent to the amount of caffeine in about 28 cups of regular coffee.
  • FDA’s current action highlights the Agency’s authority to take enforcement action against products positioned as dietary supplements where evidence suggests the potential for significant toxicity; future violations carry the risk of product seizures or injunctions to prevent firms from continuing to manufacture or market the product.  FDA has warned the industry of its intent to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.”