• As our readership is well aware, three of the rules created to implement the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs – have requirements for a supply-chain program for certain raw materials and other ingredients. FDA has designed the supply-chain program to address hazards requiring a supply-chain-applied control.
  • To meet the requirements of the supply-chain program, a co-manufacturer may need detailed information from the brand owner. FDA explains that “co-manufacturing” means a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party. Based on industry feedback, FDA has determined that the industry needs more time to establish new contracts that will allow brand owners and co-manufacturers to share certain information, such as audits of suppliers.
  • Today, the U.S. Food and Drug Administration (FDA) announced the availability of a guidance entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry.” FDA states that this guidance is designed to give certain co-manufacturers more time to meet supplier approval and verification requirements under three FDA food safety regulations.  The guidance provides that FDA does not intend to take enforcement action for two years against a co-manufacturer that is not in compliance with certain supply-chain program requirements related to supplier approval and supplier verification. This enforcement discretion is conditional on the supplier approval and verification activities being divided between the brand owner and the co-manufacturer.
  • FDA will be accepting comments on this guidance document at any time via https://www.regulations.gov.
  • USDA’s Economic Research Service (ERS) recently released results of a study examining the influence of foodstore access on grocery shopping and food spending. According to the study’s authors, researchers have taken the position that poor access to food retailers selling a wide range of healthy and affordable foods leads to poorer diet and diet-related health problems. And lack of access to stores such as supermarkets may thus mean that households rely more heavily on nearby retailers, such as convenience stores or fast-food restaurants, which do not typically offer a wide variety of healthful foods.
  • The study found that six percent of U.S. households are access-burdened: they do not use their own vehicle to travel to the store for groceries and live more than 0.5 mile from the nearest SNAP-authorized supermarket or superstore (SM/SS).  Additional highlights of the study’s findings include:
    • Seventy-seven percent of access-burdened households reported a shopping event at a supermarket, superstore, large grocery store, or warehouse store during the survey week compared to 87 percent for households with sufficient access. Of those who visited these large stores during the survey week, sufficient-access households had 2.8 shopping events at such a store, while access-burdened households averaged 2.4 shopping events; and
    • Although they average fewer trips, access-burdened households spend almost the same percentage of their weekly food expenditures at large stores as households with sufficient access—57 percent of total spending for access-burdened households and 58 percent for sufficient-access households.
    • The per capita spending of access-burdened households at such stores is slightly lower—$28.77 on average for the survey week compared with $29.97 for households with sufficient access.
  • The report’s authors noted that these findings suggest that access-burdened households overcome limited food retail options to spend similarly to sufficient-access households at large stores.
  • Microalgae can be used to make powder, oil, butter and flour and is incorporated into all types of food products, including baked goods, burgers, beverages, ice cream, infant formula or snacks.
  • Food Dive reports that a number of leading food manufacturers are incorporating microalgae into their products.  For example, Mondelez is using it in some baking items, while Dean Foods’ Horizon Organics milk line has omega-3s in the form of algal oil. And the Wall Street Journal reports that algae-derived colors (greenlighted by the FDA) may soon be widely used to color candy and gum products.
  • Given microalgae’s versatility and nutritional profile, experts expect that food and beverage products containing microalgae will continue to appear in the U.S. and other markets.
  • As previously reported on this blog, USDA submitted an interim final rule on July 6, 2017, that would—among other things—expand the types of flavored milk allowed in the school lunch program. That announcement followed a May 2, 2017 proclamation by U.S. Secretary of Agriculture Sonny Perdue explaining that USDA would provide greater flexibility in nutrition requirements for school meal programs, including providing schools with the discretion to serve flavored, 1% fat milk as part of their lunch or breakfast.
  • The School Milk Nutrition Act of 2017 (H.R. 4101), introduced by Representatives G.T. Thompson (R-PA) and Joe Courtney (D-CT), would make the changes concerning milk types allowed in the school lunch program permanent. The Act states that low-fat flavored milk may not contain more than 150 calories per 8-ounce serving. It also specifies that women and children 24-months and older in the Special Supplemental Nutrition Program for Women, Infants and Children (known as WIC) should have access to reduced-fat (2 %) milk.
  • Noting that milk consumption is declining, the legislation also directs USDA to carry out a study to determine the factors that may adversely affect milk consumption. Furthermore, the study should include recommendations, if any, to increase milk consumption in schools.
  • The proposed legislation was praised by the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF). “When kids don’t drink milk, it’s extremely difficult for them to get sufficient amounts of three of the four major nutrients most lacking in children’s diets:  calcium, potassium, and vitamin D,” said Jim Mulhern, President and CEO of NMPF, in a press release. “This legislation addresses that shortcoming both in schools and in the WIC program.
  • R. 4101 was referred to the House Committee on Education and the Workforce on Oct. 24, 2017, the same day that it was introduced.
  • Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14).  A health claim must contain the elements of a substance and a disease or health-related condition.  In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease.  Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims: (1) health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims. To date, FDA has authorized 12 SSA health claims, such as the effect of calcium and vitamin D in helping to lower the risk of osteoporosis or certain fruits and vegetables to lower the risk of cancer.
  • Today, FDA released a rule proposing to revoke its regulation authorizing the use of a health claim on the relationship between soy protein and coronary heart disease (21 CFR 101.82) on the label or in the labeling of foods.  In developing the proposed rule, the Agency reviewed more than 700 publications identified through literature searches, comments and other information, including information solicited by the FDA in 2007.
  • In a statement announcing the release of the proposed rule, Dr. Susan Mayne of FDA’s Center for Food Safety and Applied Nutrition noted that this action represents the first time FDA has considered it necessary to propose a rule to revoke a health claim. FDA indicates that it is basing this decision on its view that the totality of publicly available scientific evidence currently available calls into question the Agency’s previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. Importantly, the Agency notes that some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease.
  • The FDA plans to publish the proposed rule in the Federal Register and solicit public comments and scientific information concerning the proposal for 75 days following its imminent publication. During the rulemaking process, food manufacturers may continue to use the authorized health claim.
  • If the FDA ultimately finalizes this rule, the Agency intends to allow the use of a qualified health claim provided that there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. A qualified health claim (which requires a lower scientific standard of evidence than an authorized health claim), would permit industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction.
  • A study by the University of Florida Institute of Food and Agricultural Sciences surveyed 1,132 respondents to examine their willingness to pay for food labeled as “USDA Organic” versus “Non-GMO Project Verified.”
  • In particular, the researchers measured respondents’ willingness to pay for a box of 12 granola bars and a pound of apples.
    • When consumers looked at packages of Granola bars labeled “non-GMO Project,” they were willing to spend 35 cents more than for the boxes that had text that read, “contains genetically engineered ingredients.” With the “USDA Organic” label, consumers were willing to pay 9 cents more.
    • With apples, respondents were willing to pay 35 cents more for those labeled “non-GMO Project” and 40 cents more for those labeled “USDA Organic.”
  • The results led the researchers to conclude that many consumers do not distinguish between the “organic” and “non-genetically modified” labels.  These results follow on recent findings that sales of products labeled by the Non-GMO Project, more than doubled from 2014 to 2016 — from $7 billion to $16 billion in 2016, whereas the sales of organic foods (although gaining in popularity) have increased at a much slower rate.
  • The National Antimicrobial Resistance Monitoring System (NARMS), established in 1996, is a collaborative program of state and local public health departments and universities, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA).  NARMS gathers surveillance data from human clinical samples, slaughter samples and retail meat samples and tracks changes in the antimicrobial susceptibility of enteric (intestinal) bacteria found in ill people (CDC), retail meats (FDA), and food animals (USDA) in the U.S. NARMS data are used by FDA to make regulatory decisions designed to preserve the effectiveness of antibiotics for humans and animals.
  • A NARMS report issued this week (which covers data from calendar year 2015), found that certain types of resistance are on the rise. Namely, the report found that:
    • Seventy-six percent of Salmonella isolated from humans had no resistance to any of the 14 antimicrobial drugs tested, but among isolates showing resistance, multidrug resistance (MDR) increased from 9 percent to 12 percent driven largely by an increase in combined resistance to ampicillin, streptomycin, sulfonamides, and tetracycline among Salmonella serotype I 4,[5],12:i:-.
    • Ceftriaxone resistance either continued to decline or remained low in nontyphoidal Salmonella from all NARMS sources except turkey hazard analysis and critical control point (HACCP) samples, where the percent resistance in 2015 (15.7 percent) was the same as 2010 levels.
    • While still rare, azithromycin resistance occurred in Salmonella, in some cases in strains with resistance to other antibiotics.
    • Erythromycin resistance in Campylobacter coli increased three-to five-fold between 2011 and 2015 in isolates from humans (2.7 percent to 12.7 percent) and from chicken carcasses (3.4 percent to 12.8 percent).
    • Transmissible quinolone resistance in Salmonella may be increasing. The underlying resistance traits reside on mobile genetic elements and therefore have the potential to be shared, either alone or together with other resistance genes, with susceptible strains of Salmonella.
  • The report also found that ground turkey resistance levels continue to decline.  More specifically, from 2014 to 2015, there was a decline from 73 percent to 57 percent in the proportion of retail ground turkey Salmonella isolates resistant to at least one antimicrobial. Historically, the majority of isolates from turkey sources have been resistant to at least one antimicrobial.
  • Of note, this report covers a time period prior to the full implementation of FDA guidance recommending the reduction of medically important antibiotics in food-producing animals.  As more and more companies adopt FDA’s recommendations, it is likely that we will begin to see resistance levels decline across the board.
  • A paper recently published in the journal Applied Economics Perspectives and Policy explores how labels identifying the process in which food is produced positively and negatively influences consumer behavior.  More specifically, the researchers analyzed more than 90 academic studies on how consumers respond to food processing labels.  The study includes a list of common process labels, available here (See Table 1).  Examples include “organic,” “genetically engineered (GE),” “free range,” “fair trade,” “cage-free” and the list goes on.
  • The researchers found, in part, that food labels (such as “organic” and “fair trade”) may stigmatize foods produced with conventional processes even when there is no scientific evidence that conventionally produced foods cause harm or that such products are compositionally different from “organic” or “fair trade” products.
  • The report offers three policy recommendations:
    • Mandatory labeling of food processes should occur only in situations in which the product has been scientifically demonstrated to harm human health.
    • Governments should not impose bans on process labels because this approach goes against the general desire of consumers to know about and have control over the food they are eating, and it can undermine consumer trust of the agricultural sector.
    • A prudent policy approach is to encourage voluntary process labeling, perhaps using smartphone technology similar to that proposed in 2016 federal legislation related to foods containing ingredients that were genetically engineered.
  • The U.S. Food and Drug Administration (FDA) introduced a new web page that consolidates the compliance dates for the Agency’s Food Safety Modernization Act (FSMA) rules. The rules that include compliance dates, in the order they became final, are:
    • Preventive Controls for Human Food
    • Preventive Controls for Animal Food
    • Produce Safety
    • Foreign Supplier Verification
    • Sanitary Transportation
    • Intentional Adulteration
  • These rules have staggered compliance dates, in part, based on the size of a business. FDA also has provided a graphic timeline that shows these staggered compliance dates by month and year.
  • There are no compliance dates for the Accredited Third-Party Certification rule since it is a voluntary program. However, as previously reported on this blog, FDA launched a website earlier this year where an organization can apply to be recognized as a Third-Party accreditation body.
  • FDA also announced that the web pages for the Preventive Control for Human Food and Preventive Controls for Animal Food have been updated as of Oct. 19 and Oct. 20, respectively.
  • Keller and Heckman attorneys regularly advise clients on compliance with FSMA rules. Please feel free to contact us at fooddrug@khlaw.com with any questions.
  • The Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act require foreign countries that export meat, poultry, and egg products to the U.S. to establish and maintain systems equivalent to the U.S. inspection system. The Food Safety and Inspection Service (FSIS) is responsible for ensuring these products meet all safety standards applied to foods produced in the U.S.
  • A new report released by the Office of the Inspector General (OIG) of the U.S Department of Agriculture (USDA) says that USDA’s FSIS needs to improve its methods for determining whether foreign countries exporting meat, poultry and egg products to the U.S. have equivalent food safety standards. Key findings from the OIG report include:
    • Exporting countries are not consistently audited in compliance with FSIS policy;
    • Agency policies and procedures do not contain sufficient guidance for conducting ongoing equivalence verification audits;
    • FSIS officials do not consistently perform or document procedures when audits are performed;
    • FSIS has not taken corrective actions in response to previous audit recommendations; and
    • In the period reviewed, FSIS did not obtain details identifying the date or reason why certified foreign establishments were removed from the program after they were deemed no longer eligible to export product to the U.S.
  • In short, the OIG report concludes that FSIS equivalency audits in the period reviewed were inconsistent and that the inspection program is vulnerable to weaknesses that increase the risk of contaminated or adulterated food being imported into the U.S.
  • OIG recommends that FSIS strengthen its oversight of the equivalence process and revise its guidance and management control manual for conducting ongoing equivalence verification audits. FSIS has generally agreed to take corrective actions based on OIG’s recommendations.