FDA issues guidance on production of exempt infant formula.

  • In 2014 — 17 years after the initial proposed rule was issued — FDA finalized its rulemaking related to the manufacture of infant formula.  However, the rule does not apply to facilities that manufacture “exempt infant formula,” defined by law as an infant formula which is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem.  FDA indicated its intent to address requirements for exempt infant formula in a separate rulemaking.
  • In April 2016, FDA issued final guidance on exempt infant formula production.  In the guidance, FDA recognizes that exempt infant formulas may need to be manufactured differently than non-exempt infant formulas due to the specific medical needs that exempt infant formulas are intended to meet.  However, FDA concludes by recommending that manufacturers of exempt infant formulas comply with the 2014 final rule to the extent practicable in the production of their products.
  • According to FDA, as of March 2016, only 5 infant formula manufacturers produce exempt formulas marketed in the U.S.  Of those companies, only 1 produces solely exempt infant formula in its facilities.  Although FDA’s final guidance on exempt infant formula may not directly affect many entities, it is nevertheless likely to garner attention and interest, especially as it relates to ensuring the safety and nutritional quality of a sole-source food for a particularly vulnerable population.

FDA warns companies marketing dietary supplements that contain methylsynephrine.

  • As previously covered on this blog, FDA has the authority to take enforcement action against unlawfully marketed and/or dangerous dietary ingredients in dietary supplements.  In the last year, FDA has taken action against beta-methylphenethylamine (BMPEA), 1,3-Dimethylbutylamine (DMBA), and kratom, to name a few prominent examples.
  • FDA recently sent Warning Letters to seven companies marketing dietary supplements that contain the stimulant, methylsynephrine (also called oxilofrine).  FDA’s position is that methylsynephrine does not meet the statutory definition of a “dietary ingredient” permitted for use in dietary supplements.  By law, a dietary supplement is defined as a product intended to supplement the diet that bears or contains one of the following dietary ingredients:  a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.
  • Although the Warning Letters do not cite the potential health risks associated with methylsynephrine consumption, the substance is known to be a powerful stimulant and has been banned by the World Anti-Doping Agency, Major League Baseball, National Football League, and other sports organizations.  An FDA spokesperson indicated that the Agency had learned of 47 adverse reactions associated with the stimulant.  Some media reports are characterizing methylsynephrine as the latest in a string of stimulants intended to replace ephedrine, which was banned in 2004 due to its serious side effects.

The Daily Intake will be on hiatus during our Practical Food Law Seminar — we will return on Monday, April 18.

FSIS proposes to eliminate trichinae control requirements it deems unnecessary.

  • Trichinella is a parasitic worm that can infect humans and other animals.  Although relatively few cases of human infection are reported each year, swine are known to be the primary source of such infections.  In 2001, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) proposed to establish performance standards for all ready-to-eat (RTE) and all partially heat-treated meat and poultry products.   The proposed performance standards included both levels of pathogen reduction and limits on pathogen growth that official meat and poultry establishments would be required to meet in the production of these products.
  • FSIS recently published a supplement to the proposed rule that would eliminate regulatory provisions for the prescribed treatment of pork and pork products, thus providing establishments with the flexibility to decide whether and how to treat products to eliminate trichinae.  According to the rule supplement, many establishments producing pork already address trichinae in their hazard analysis and critical control points (HACCP) plans or otherwise.  FSIS has found that the risk for Trichinella infection has decreased based on the industry’s adherence to HACCP guidelines.
  • In addition to the Trichinella-specific change above, FSIS proposes to consolidate other regulations on thermally processed, commercially sterile meat and poultry products and to make other changes that will streamline and clarify the regulations.  Because of the length of time that has elapsed since publication of the original proposal, FSIS is inviting comments on the supplemental proposal until May 27.

USDA launches program to facilitate GAP certification for small and mid-sized entities in the produce sector.

  • Good Agricultural Practices (GAPs) are a voluntary set of recommendations originally developed by the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) in 1998.  USDA’s Agricultural Marketing Service (AMS) currently operates an audit/certification program to verify that farms use GAPs.  The program typically is used by growers and packers to satisfy contractual requirements imposed by retail and food service customers.
  • On April 4, AMS announced the launch of “GroupGAP,” a new certification program intended to help small and mid-sized growers and cooperatives meet retailers’ on-farm food safety requirements.  In explaining the program rationale, AMS acknowledged that GAP certification may be cost-prohibitive for smaller farmers; the new program enables cost-sharing across a group of growers.
  • In the future, many farms will need to come into compliance with the Produce Safety Standards under the FDA Food Safety Modernization Act (FSMA).  However, FDA continues to recognize the importance of GAPs.  The final rule implementing the Produce Safety Standards recognizes the relevance of GAP certification and recommends that any farms not covered by the Produce Safety Standards continue to observe GAPs in their operations.

FDA releases final rule to implement sanitary food transportation requirements under FSMA.

  • On April 5, FDA announced the issuance of a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a pre-publication copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule.
  • The final rule establishes requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport.  Companies generally must comply with the new requirements by April 2017.  Small businesses have until April 2018 to comply.
  • FDA is hosting a webinar on April 25 to address the new sanitary food transportation requirements, and Keller and Heckman LLP is preparing a full analysis of the final rule in the meantime.

FDA proposes limit for inorganic arsenic in infant rice cereal.

  • Arsenic is a naturally-occurring element that can be found in water, soil, and air.  Long-term exposures to one type of arsenic — “inorganic arsenic” — have been associated with higher rates of certain health risks, such as cancer and heart disease.  Rice is suspected to be a leading dietary source of inorganic arsenic, both because of its popularity in the diet as a staple food and because the crop has the potential to readily absorb arsenic from the soil or water as it grows.  For the past several years, FDA has been conducting product testing related to inorganic arsenic exposure.
  • On April 1, FDA proposed an action level (or limit) of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal and also provided targeted information to help pregnant women reduce their exposure to inorganic arsenic.  This proposal is the product of:  (1) extensive FDA testing of both rice and non-rice products; (2) a 2016 risk assessment that indicated an association between adverse pregnancy outcomes and neurological effects in early life related to inorganic arsenic exposure; and (3) a feasibility assessment related to reducing inorganic arsenic in infant rice cereal.
  • In terms of impact on the industry, FDA testing indicates that the majority of infant rice cereal currently on the market either meets, or is close to, the proposed action level.  From the standpoint of consumer impact, the instant action is targeted at pregnant women and infants; FDA is not advising the general population to change rice consumption patterns at this time.

FDA sued over approval of genetically engineered salmon.

  • In November 2015, FDA issued its first approval for a genetically engineered (GE) animal intended for direct human consumption.  The AquAdvantage Salmon is an Atlantic salmon engineered to grow twice as fast as its natural counterpart.  Since the approval, the GE salmon has been mired in controversy.  A provision in the omnibus spending bill passed in December 2015 blocks the sale of GE salmon until FDA publishes labeling guidelines to inform consumers of the product’s GE content.
  • A number of environmental and consumer advocacy groups — including the Center for Food Safety, Food and Water Watch, and Friends of the Earth — have filed a lawsuit against FDA, asserting that the Agency overstepped its authority in approving the GE salmon in the first place.  In addition to challenging the substantive merits of FDA’s decision to approve the product, the complaint alleges that FDA’s lacks the statutory authority to regulate GE animals as “new animal drugs” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • The current lawsuit is yet another development in the long-running debate over the safety of GE organisms in the food supply.  FDA does not comment on pending litigation as a matter of policy, but we anticipate that the Agency will continue to support the position it stated in its initial approval of the product, i.e., that the GE salmon are “as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.”

Newly-issued report describes trends in FDA import refusals.

  • FDA is responsible for overseeing the safety of the U.S. food supply, which includes significant quantities of imported food.  Due in part to resource constraints, FDA inspects only a fraction of the foreign facilities that produce food for the U.S. and physically examines only a small percentage of shipments offered for import.  The Agency uses a risk-based approach to prioritize inspections.  The Economic Research Service (ERS) of the U.S. Department of Agriculture (USDA) periodically analyzes FDA import refusal patterns to develop a better understanding of the countries and products that pose the greatest risk to U.S. consumers.
  • ERS has just released a report analyzing food import refusals from 2005-2013.  The following list provides the food product categories that accounted for the majority of shipments refused, along with their refusal rates and the most common reason for refusal within each category:
    • (1) fishery and seafood products – 20.5% refusal rate – sanitary violations/filth;
    • (2) vegetable products – 16.1% refusal rate – unsafe pesticide residues;
    • (3) fruit products – 10.5% refusal rate – sanitary violations/filth;
    • (4) spices, flavors, and salts – 7.7% refusal rate – Salmonella contamination; and
    • (5) candy without chocolate and chewing gum – 7.2% refusal rate – unsafe color additives.
  • The countries with the most shipments refused were Mexico, India, and China, each of which had distinct product categories subject to the most refusals, i.e., vegetables, spices, and seafood, respectively.
  • ERS notes in its report that despite the increase in import volume over the 8-year period analyzed, FDA’s overall refusal rate has remained stable.  The data do not permit researchers to draw conclusions about the reason for this trend — it could be due to foreign suppliers’ improved compliance practices, or it could be due to continued strain on FDA’s resources and capacity to inspect, detain, and refuse imported food.  It will be particularly interesting to see what the next ERS report on this topic indicates, as the next analysis presumably will include the time period in which FDA’s Foreign Supplier Verification Program (FSVP) will have taken effect.

USDA proposes rule to enhance enforcement of nutrition standards in schools.

  • Enacted in 2010, the Healthy, Hunger-Free Kids Act (HHFKA) set nutrition standards for schools.  First Lady Michelle Obama is a prominent supporter of the law and its underlying goal to improve childhood nutrition and combat obesity.
  • On March 29, USDA’s Food and Nutrition Service issued a proposed rule to improve the integrity of child nutrition programs under the HHFKA.  Specifically, the proposed rule would establish criteria for assessments against, and penalties for, state agencies and program operators who violate program requirements.  Under the proposal, a school or school system would face tiered financial penalties based on the reimbursement earned by the school food authority or school for the program in which the violation occurred:  after the first assessment, up to 1% of the amount of meal reimbursements earned for the fiscal year; after the second assessment, up to 5%; and after the third or subsequent assessment, up to 10%.
  • Although penalty provisions already existed, reports indicate that the government has faced challenges with enforcement.  The goal of the proposed rule is to improve enforcement capabilities, and it is anticipated that penalties will be levied in “instances of severe mismanagement of a program, disregard for a program requirement of which the program operator has been informed, or failure to correct repeated action.”  The proposed rule is open for comment until May 31, 2016.

 

FDA announces FSMA funding opportunity for states to implement produce safety rule.

  • With the rollout of the FDA Food Safety Modernization Act well underway, questions continue to arise regarding the adequacy of funding support for the sweeping reforms that the law requires.
  • FDA recently announced a funding opportunity for all states and U.S. territories, specifically to help support implementation of FSMA’s produce safety standards.  The $19 million funding allocation for FY 2016 will support up to 55 awards to assist states with planning, infrastructure building, training, education, and other activities related to the development of state produce safety programs.  Assuming that Congress continues to make funding available, this funding opportunity will continue for five years.
  • Due to the inherent complexity and breadth of the FSMA requirements, FDA must rely on strong partnerships with state agencies to ensure comprehensive and effective implementation.