Consumer protection group urges expedited compliance with new nutrition labeling requirements.

  • As previously covered on this blog, FDA recently issued its long-awaited final rules to revise the nutrition and dietary supplement labeling and serving size requirements.  Although the rules take effect on July 26, 2016, companies generally have 2 years from the effective date to comply with the final rule, i.e., July 26, 2018.
  • The consumer protection group, Environmental Working Group (EWG), already has sent targeted letters to major cereal manufacturers to request that they take action to update the nutrition information for their products as soon as possible, and well in advance of the 2018 compliance date.  The letters cite concerns about sugar consumption from breakfast cereals, particularly among children.  In each letter, EWG lists company products that will be affected by the new requirements and provides new serving sizes and sugar content statements for each.  EWG specifically asks each company to update the Nutrition Facts panels available on their websites as soon as possible, and to “expedite” changes to product packaging as well.
  • EWG’s action illustrates the type of external pressure that the food industry may face over the next two years.  Although it will take substantial time and resources for various companies to recalculate and relabel their products, extra-regulatory forces such as consumer protection groups may push entities to work as quickly as possible to provide consumers with the “new facts.”

Please join us on June 21 (1 pm Eastern) for a complimentary webinar that will review the changes set forth by these new regulations and the impact these changes will have on your products. To register to attend the webinar, click here.

FDA takes significant action to stop illegal drug sales online.

  • FDA has broad regulatory authority over the marketing of food, drugs, medical devices, and cosmetics in the U.S.  Although many of the Agency’s enforcement actions target physical facilities and products on shelves, FDA also has authority over e-commerce, i.e., the significant sales of FDA-regulated products that take place online.
  • On June 9, FDA announced that it had taken action against 4,402 websites illegally selling unapproved prescription drugs to U.S. consumers.  The crackdown was part of a global cooperative effort led by the International Criminal Police Organization (ICPO or INTERPOL), the goal of which was to identify the makers/distributors of illegal drugs and to remove these products from the supply chain.  To implement the operation, FDA worked with U.S. Customs and Border Protection to conduct extensive inspections at International Mail Facilities (IMFs).  Working with other federal agencies, FDA screened and seized drugs received through IMFs in San Francisco, Chicago, and New York.  Ultimately, 797 packages were detained.  The Agency also sent formal complaints to domain registrars requesting the suspension of the 4,402 websites and issued Warning Letters to the operators of 53 websites.
  • FDA’s significant action against illegal online sales illustrates the Agency’s authority over e-commerce and serves as a caution to the industry that online marketing should not be viewed as a means to evade the reach of the Federal Food, Drug, and Cosmetic Act.

Congress considers ending USDA catfish inspection program.

  • As previously covered on this blog, in the 2008 Farm Bill, Congress required FDA to divest its authority over the inspection of Siluriformes fish (including catfish) to USDA’s Food Safety Inspection Service (FSIS).  FSIS issued a final rule to establish the inspection program in November 2015 and FDA announced the completion of its transfer of the program to FSIS in May 2016.
  • Barely weeks after the long-awaited transfer took place, the Senate voted to shut down the inspection program.  If the relevant Joint Resolution is approved by the House of Representatives and signed into law, the FSIS catfish inspection program would be over almost as soon as it began.  Inspections presumably would revert back to FDA.
  • The issue is likely to be contested, as indicated by a letter from a bipartisan congressional group to Speaker Ryan and Minority Leader Pelosi, urging the House not to approve the Joint Resolution, and stating that FDA’s inspection regime had been inadequate and conducted inspections on only 0.2% of imported catfish species.  It remains to be seen how the House will vote, but in the meantime, this long-awaited and long-debated inspection program continues to generate controversy.

HHS OIG issues early alert criticizing FDA’s food recall procedures.

  • Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods.  However, FDA has only threatened the use of this authority twice.  In reality, firms continue to work voluntarily with FDA to recall risky foods under the Agency’s recall procedures and guidance.
  • On June 9, 2016, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued an “early alert” to indicate that its ongoing audit of FDA’s food recall program found that “FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.”  Stating that FDA failed to ensure the prompt recall of risky foods, the OIG asserted that “consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”  The OIG cited specific cases in which firms delayed the recall of foods potentially tainted with Salmonella and Listeria monocytogenes until 165 days and 81 days after FDA became aware of the contamination risk.  The OIG did not provide any specific recommendations regarding how FDA should improve its policies, only that the Agency “update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.”  A copy of the audit report is available here.
  • FDA issued a press release responding to the OIG’s findings, acknowledging that among the thousands of food recalls it had overseen in a 3-year period, a small number had fallen well outside the average time frame of less than a week for recall initiation.  Characterizing these days as “unacceptable,” FDA stated that it is already taking concrete steps to address the OIG’s concerns, including establishment of a rapid-response team made up of Agency leaders, and the introduction of new technologies to expedite the process.

FDA issues 5th annual Reportable Food Registry report.

  • Since 2009, FDA has operated the Reportable Food Registry (RFR), an electronic portal to which instances of “reportable food” must be submitted.  A “reportable food” is a food (other than dietary supplements and infant formula) that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. The definition of “reportable food” is essentially identical to the criteria established for a Class I recall.
  • FDA recently released its 5th annual RFR report, which summarizes data from the Registry’s first five years of operation.  FDA received 909 reportable food entries in year 5 with 201 of these being primary reports (initial reports about a food-related safety concern), 464 being subsequent reports from suppliers or recipients of a product for which a primary report had been submitted, and 244 being amended reports (to correct or add information to previously submitted reports).  Undeclared allergens triggered almost half (47%) of the RFR reports submitted in year 5, with most of these reports associated with bakery products.
  • FDA noted that although the total number of RFR submissions in year 5 represented a decrease as compared to the previous two years, amended report submissions are on the rise, which may indicate industry cooperation and familiarity with the reporting process.  Under the FDA Food Safety Modernization Act (FSMA), FDA has been tasked with modifying the RFR system to make it more “consumer-oriented.”  Although there has not been much activity since FDA published an advance notice of proposed rulemaking (ANPRM) in 2014, the industry should stay tuned for potential developments on this front.

Hamburg worries mandatory GMO labeling could send the wrong message

  • During her tenure as FDA Commissioner, Dr. Margaret Hamburg defended the Agency’s position that it is inappropriate to require labeling of foods that contain genetically engineered ingredients without evidence of material differences between bioengineered foods and their conventional counterparts.
  • On June 6, 2016, Hamburg, who served as Commissioner from May 2009 to March 2015, again addressed the topic of GMO labeling.  Commissioner Hamburg described mandatory GMO labeling as “particularly troubling,” because it could send the message that GMOs are dangerous.  Hamburg reasserted “the need to have science-based approaches in terms of what the government would require as mandatory labeling,” particularly in an area of science most consumers “don’t fully understand.” While Hamburg stated she believes people who want to avoid consuming GMO-containing foods should be able to do so, she indicated that voluntary labeling can meet this need. [Remarks begin at 47:00]
  • Commissioner Hamburg’s concerns that the U.S. “not enter a period of science denialism out of fear” echo the arguments of others opposed to mandatory GMO labeling, including the American Medical Association, which has stated it is in favor of “FDA’s science-based labeling policies [which] do not support special labeling,” and the American Association for the Advancement of Science, which stated that “mandating [a GMO] label can only serve to mislead and falsely alarm consumers.” Nevertheless, consumer interest in mandatory labeling of GMO-containing foods remains high.

FDA investigating low levels of peanut residue found in flour.

  • Peanuts are among the “Big 8” allergens covered by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).  Food companies must declare the presence of major allergens on the labels of food products.  Additionally, as part of good manufacturing practices (GMPs), facilities must take steps to protect food against unintentional cross-contact with allergens.
  • FDA recently issued a safety advisory to consumers, advising them to avoid specific products because of peanut residue that may have been present in the flour used to make these foods.  The flour supplier notified FDA that sampling by a customer found peanut residue in cookies and that subsequent investigation identified soft red winter wheat flour as the source.  Both the supplier and FDA have reported additional samples testing positive for peanut residue since that time.  The supplier ceased manufacturing and distribution of the flour product and conducted a recall, which implicates food processors (since the supplier does not sell directly to consumers).  FDA is actively working with food processors to determine whether their products pose a safety hazard that would trigger a recall.  Of some comfort to the food industry, FDA does not publicize the names of each potentially affected recipient, noting that “it is prohibited by law from releasing publicly certain information about supply chains, such as the names of customers, if it constitutes confidential commercial information.”
  • It is somewhat unusual, although not unprecedented, for FDA to issue consumer safety advisories in this type of situation.  This case illustrates the way in which a safety problem at a single supplier’s facility can affect multiple processors and finished foods.

K&H publishes summaries of final rules to revise nutrition and supplement facts labeling requirements and serving sizes.

  • As promised, Keller and Heckman LLP has prepared summaries of FDA’s recently-issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations.
  • The final rule revising the Nutrition and Supplement Facts Labels:  (1) updates the list of nutrients that are required or permitted to be declared; (2) provides updated Daily Reference Values and Reference Daily Intakes; (3) amends requirements for foods represented or purported to be specifically for children under the age of 4 years, pregnant women, and lactating women and establishes nutrient reference values specifically for these population subgroups; and (4) revises the format and appearance of the Nutrition and Supplement Facts labels.  In addition, the rule now provides a new definition for “dietary fiber”.  Click here for our summary of this rule.
  • The final rule revising serving sizes:  (1) changes Reference Amounts Customarily Consumed (RACCs) for certain foods; (2) creates new reference amount categories and reference amounts; (3) amends the definition of a single-serving container; and (4) requires dual column nutrition labeling for certain food containers.  Click here for our summary of this rule.
  • The final rules are effective July 26, 2016.  Companies generally have 2 years from the effective date to comply with the final rule, i.e., July 26, 2018, except that manufacturers with less than $10 million in annual food sales have 3 years from the effective date to comply, i.e., July 26, 2019.

Please join us on June 21 (1 pm Eastern) for a complimentary webinar that will review the changes set forth by these new regulations and the impact these changes will have on your products. To register to attend the webinar, click here.

FDA issues draft guidance to encourage food industry to reduce sodium added to food.

  • According to FDA, average sodium intake in the U.S. is too high at approximately 3,400 mg/day.  Approximately 75% of total sodium intake comes from processed and commercially prepared foods.  For years, the Agency and the food industry have considered various approaches to encourage reduction of sodium intake to 2,300 mg/day, the level supported by leading experts and the overwhelming body of scientific literature.
  • 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.  To develop the guidelines, FDA began with baseline sodium concentrations for various identified food categories, with each baseline representing a tentative assessment of the approximate “state of the market” regarding sodium concentrations in each category in 2010.  Using these baselines, FDA developed quantitative target mean concentrations for the identified food categories, including both short-term (2-year) and long-term (10-year) goals.  Significantly, FDA does not:  recommend any specific methods and technologies for sodium reduction; prescribe how much of any individual sodium-containing ingredient should be used in a formulation; focus on foods that contain only naturally-occurring sodium; or address salt that individuals add to their food.
  • In the Federal Register notice announcing availability of the draft guidance, FDA poses a series of specific questions to stakeholders, specifically related to:
    • (1) Whether the Agency has appropriately grouped the food categories for the purpose of goal-setting, and whether any foods that contribute to sodium intake have not been effectively captured;
    • (2) Whether the baseline sodium concentration values used by the Agency are reasonably representative of the state of the food supply in 2010;
    • (3) Whether there are categories for which the 2-year target concentration goals are infeasible (and if so, why);
    • (4) Whether the short-term (2-year) timeframe for these goals is achievable (and if not, which timeframes would be possible);
    • (5) Whether there are categories for which the 10-year target concentration goals are infeasible (and if so, why);
    • (6) Whether the long-term (10-year) timeframe for these goals is achievable (and if not, which timeframes would be possible);
    • (7) Which specific research needs or technological advances could enhance the food industry’s ability to meet these goals; and
    • (8) What amendments to FDA’s standard of identity regulations are needed to facilitate sodium reduction by permitting alternative ingredients to be used in standardized foods.
  • FDA is accepting comments on the draft guidance in two waves, with comments on issues 1-4 (as numbered above) due by August 31, 2016, and comments on issues 5 through 8 (as numbered above due by October 31, 2016.

K&H publishes summary of FSMA final rule to implement intentional adulteration requirements for human food.

  • As promised, Keller and Heckman LLP has prepared a summary of FDA’s final rule to implement the intentional adulteration provisions of the FDA Food Safety Modernization Act (FSMA).
  • Click here for our summary of the rule and its implications for the food industry.
  • Although the core components of the intentional adulteration requirements remain substantially similar to those in the proposed rule, FDA has revised and clarified the final rule in several key respects.  Of particular benefit to the food industry, FDA has extended the compliance date to 3 years after the effective date (i.e., July 26, 2019), as compared to the initial proposal of a 1 year compliance deadline.

We will continue to monitor and report on FDA’s activities to implement this rule and other FSMA related activities.  Please email fooddrug@khlaw.com and let us know if you have any questions or if you would like to discuss the impact of the final rule or any other FSMA related issues in the meantime.