• On December 3, FDA issued an alert to pet owners and veterinary professionals about the recalls of several dry dog foods with potentially toxic levels of Vitamin D. Thus far, FDA believes the affected dog food has been produced by one contract manufacturer who makes dry dog food for several national brands. However, the name of the contract manufacturer has not yet been released. In order to ensure all affected dry dog food brands are accounted for, FDA is working with the contract manufacturer to generate a comprehensive list of the dry dog food brands that they work with.
  • The issue came to FDA’s attention after one brand notified FDA that it was recalling their dry dog food due to potentially toxic levels of Vitamin D. The reason for the recall arose after the brand had received complaints from customers that their dogs were experiencing symptoms of Vitamin D toxicity. It appears that shortly thereafter, other pet food brands who use the same contract manufacturer, followed suit and also instituted recalls. Thus far, eight brands have instituted recalls of products that were sold nationwide, however FDA notes that the issue is still developing and additional brands could also be recalled.
  • Testing conducted on the dry dog food samples found excessive, potentially toxic levels of Vitamin D. In some cases, the dry dog food contained as much as 70 times the intended amount of Vitamin D. While Vitamin D is an essential nutrient that regulates the calcium and phosphorus balance in a dog’s body, exposure to very high amounts can cause serious health problems, such as kidney failure or death.
  • FDA’s alert warned pet owners to discontinue feeding the recalled dry dog food products – a list of the affected brands, flavors, and lot numbers is provided by FDA on their website. Retailers have also been advised not to sell the recalled products and to contact consumers who have purchased such products, if possible. Additionally, FDA asked veterinarians who suspect that their patients have Vitamin D toxicity to report the events through a Safe Reporting Portal or by calling local FDA Consumer Complaint Coordinators. Pet owners are also encouraged to report suspected cases.
  • The U.S. Food and Drug Administration (FDA) announced the availability of an online educational and training module that explains the types of establishments and foods that are covered by the menu labeling regulations. The Agency also recently published two fact sheets for industry on menu labeling and declaring calories.
  • By way of background, FDA issued a final rule on Nutritional Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments on Dec. 1, 2014 (see 79 Fed. Reg. 71155) and published a final guidance on the menu labeling provisions in April 2016. As reported on this blog, FDA issued a supplemental guidance document on the Menu Labeling Rule on May 7, 2018, the same day that the new requirements became effective. That guidance addresses concerns raised by stakeholders, such as calorie disclosure signage for self-service food, various methods for providing calorie disclosure, and criteria for distinguishing between menus and marketing material.
  • The objectives of the newly released Menu Labeling Regulation Module are:
    • To identify key factors that led to the regulation of menu labeling;
    • To describe the components of the menu labeling rule;
    • To explain the Agency’s current strategy; and
    • To locate appropriate resources.
  • FDA explained in a Constituent Update on the module that during the first year of implementation of the menu labeling regulations, it will focus on education and outreach and working cooperatively with establishments to help them comply.
  • The European Food Safety Authority’s (EFSA) Panel on Contaminants in the Food Chain (CONTAM) has opened a public consultation into a draft opinion on the health risks of cyanogenic glycosides in foods other than raw apricot kernels. Cyanogenic glycosides contain chemically bound cyanide and are present in foods such as apricot kernels, almonds, linseed, or cassava. When the plant cells are damaged, by for example grinding or chewing, cyanogenic glycosides and their degrading enzymes are brought into contact and cyanide is released. Cyanide is readily absorbed by the gastrointestinal tract and rapidly distributed to all organs. Cyanide poisoning can cause a number of health issues, and in extreme cases, can be fatal.
  • In 2016, EFSA evaluated the acute health risk of cyanogenic glycosides in raw apricot kernels. In that 2016 scientific opinion, EFSA set a safe level for one-off exposure (known as an acute reference dose (ARfD)) of 20 µg/kg body weight. EFSA recommended that adults could consume three small apricot kernels without exceeding the AFrD.
  • In its latest draft opinion on the health risk of cyanide in foods, the CONTAM panel reviewed 2,586 analytical results on total cyanide in foods, and the highest occurrence values were in bitter almonds and linseed. The panel concluded the AFrD of 20 micrograms per kilogram of body weight was applicable for acute effects of cyanide regardless of the dietary source. Ultimately, EFSA’s review concluded that it is unlikely that there is a health risk from cyanogenic glycosides in foods other than raw apricot kernels. Interested parties are invited to submit written comments by January 25, 2019.
  • In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, and has been marketed in the U.S. to treat muscle pain, diarrhea, and opiate withdrawal.
  • Over the past year, FDA has issued numerous warnings about the serious risks associated with the use of kratom. The agency has also issued an import alert, seized product containing kratom, and issued warning letters to kratom marketers. Most notably, earlier this year, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.
  • Continuing its actions to address the regulation and enforcement of kratom, the Commissioner’s November 27th statement notes that FDA scientists tested 26 separate kratom products obtained by field investigators. Lead and nickel were found at levels not considered safe for human consumption. In addition to those 26 products, the Commissioner noted FDA’s concern that there may be other kratom products on the market that also contain heavy metals. In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider.
  • In response to confusion regarding Section 25600.2 of the new Article 6 warning regulations, California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed amendments to clarify how a product manufacturer—and other parties that may receive the products before the retailer—can pass warning information (and the responsibility to warn) along the supply chain and ultimately onto retailers.
  • Section 25600.2 is in part intended to reduce the burden on retailers to provide consumer product warnings by requiring a manufacturer, producer, packager, importer, supplier or distributor of a consumer product (without a warning on its label) to provide the retailer with a formal notice that includes any warning materials that the retailer would need to provide the warning to consumers (e.g., shelf signs, tags, internet warning language, etc.).
  • The current language requires the notice to be sent to “the authorized agent for the retail seller.”  The proposed amendments to Section 25600.2 would allow parties in the supply chain to provide the notice to the “the authorized agent for business to which they are selling or transferring the product” (i.e., to provide notice to the next link in the supply chain, even if the next link is not the retailer).  Also, to avoid a situation in which a business has no “authorized agent” to accept the notice, the amendments would allow the notice to be sent to “the legal agent for service of process” for the business.
  • Acknowledging the complexity of some supply chains, OEHHA intends the amendments to clarify Section 25600.2 and facilitate the transfer of warning information (as well as the responsibility to warn) along the supply chain.  The amendments are not intended to reflect a shift in OEHHA’s approach to underlying policy issues like minimizing the burden on retailers.  Comments are being accepted through December 31, 2018.
  • After the mid-term election earlier this month, California made cage-free eggs a state law. With 62% of the votes, California voters overwhelmingly approved Proposition 12, also known as the Prevention of Cruelty to Farm Animals Act, which requires that all eggs sold in the state come from cage-free hens by 2022. Proposition 12 also bans the sale of pork and veal in California from farm animals raised in cages that do not meet new minimum size requirements. In other words, farmers across the country who sell eggs, veal, and pork in California will be required to comply with Proposition 12.
  • The Act builds on a measure passed in 2008, Proposition 2, which banned keeping hens, calves, and pigs in cramped cages. While that measure took effect in 2015, it lacked specific size requirements and did not apply to out-of-state farmers who sold in California. Proposition 12 outlines specific size requirements and applies to out-of-state farmers that sell eggs, veal and pork in California. Starting in 2020, calves must have at least 43 square feet (4 square meters) of usable floor space, while breeding pigs must have at least 24 square feet (2.2 square meters) of floor space by 2022. By 2020, egg-laying hens must be given 1 square foot (144 square inches) of floor space each, until 2022 when all egg-laying hens must be cage-free.
  • Both the Sierra Club and the Humane Society of the United States supported California’s Proposition 12, while groups like the Association of California Egg Farms, the California Pork Producers Association, and National Pork Producers Council opposed the measure and argued it will cause consumers to pay more for eggs, veal, and pork. Nonetheless, supporters of the measure are understandably pleased with the outcome. Sara Amundson, president of the Humane Society Legislative Fund, stated that “the passage of Proposition 12 is groundbreaking for the welfare of animals and has raised the bar at an important time in our consideration of what farm to table means in this country.”
  • The California Department of Food and Agriculture and the California Department of Public Health are responsible for the implementation of and compliance with Proposition 12. Violations of the measure are classified as misdemeanors, with fines reaching up to $1,000.
  • With the passage of Proposition 12, California is following Massachusetts, which passed the Massachusetts Minimum Size Requirements for Farm Animal Containment (known as Question 3) in November of 2016. Proposition 12 is identical to the Massachusetts law in that it bans the sale of products from pigs, calves, and hens that are not provided with adequate floor space and is to take full effect in 2022. The Humane Society of the United States also supported the Massachusetts measure.
  • As we reported on this blog last week, FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, were investigating a multistate outbreak of E. coli O157:H7 illnesses that was likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and retailers and restaurants not to serve or sell any until more was known about the source of the outbreak. We also noted that the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency also were coordinating with U.S. agencies as they investigated a similar outbreak in Canada.
  • On November 26, FDA announced that the E. coli O157:H7 illnesses were likely linked to romaine lettuce grown in California this fall. Preliminary traceback information indicates that ill people were exposed to romaine lettuce harvested in the central coast growing regions of northern and central California, the Agency reported. Consequently, FDA said that consumers and retailers no longer need to avoid using romaine lettuce that is certain to have been harvested from areas outside of the central coast growing regions of northern and central California.
  • FDA further announced that—based on discussions with producers and distributors—romaine lettuce entering the market will now be labeled with a harvest location and date or labeled as being grown hydroponically or in a greenhouse. “If it does not have this information, you should not eat or use it,” FDA cautioned. The United Fresh Produce Association issued a press release on November 26 confirming that a labeling agreement was negotiated between FDA and a number of romaine grow-shipper-processors, who pledged to label their romaine products with the region where they were grown and the approximate harvest date. Other produce associations, including the United Fresh Produce Association, also agreed to support the initiative, according to the release.

 

  • The Dietary Supplement Health and Education Act of 1993 (DSHEA) was intended to provide a framework for FDA to regulate dietary supplements.  DSHEA established a new category of permitted claims for dietary supplements called “statements of nutritional support.”  Claims of mitigating or treating a disease, however, are “drug claims” and are not permitted on products marketed as dietary supplements.  As reported on this blog, FDA has recently stepped up enforcement action against kratom dietary supplements with label claims indicating they are drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (namely, opioid use withdrawal in the case of the kratom products).
  • Last week FDA posted warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies claim treats opioid use disorder (OUD), pain and anxiety, and other conditions.  As was the case with kratom, FDA actions against products containing tianeptine follow reports of serious adverse events associated with the use of the dietary supplement products.
  • In a November 20, 2018 press release, FDA Commissioner Scott Gottlieb characterized the action against tianeptine as part of a broader effort to protect consumers from products illegally marketed as dietary supplements and he promised an upcoming announcement of a new FDA enforcement policy.  Further, Dr. Gottlieb indicated that FDA is re-examining its resources and authorities related to products marketed as dietary supplements.
  • FDA’s actions against opioid-related dietary supplements harkens back to its release on November 9, 2004 of a “strategy for dietary supplements (discussed here) that followed enforcement action against products containing androstenedione.  FDA’s 2004 strategy has three prime components: (1) monitoring and evaluating product and ingredient safety; (2) assuring product quality; and (3) monitoring and evaluating product labeling.  Since FDA is faced with statutory limits on its authority to regulate dietary supplements, the major effect of FDA’s revamped strategy is likely to be the devotion of more resources to enforcement efforts.  At the very least, product manufacturers can expect FDA to increase its scrutiny of claims made for dietary supplements and to be more aggressive in pursuing enforcement action against products that do not meet the current standards.

 

  • The FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, are investigating a multistate outbreak of E. coli O157:H7 illnesses that are likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and retailers and restaurants not to serve or sell any until more is known about the outbreak.
  • According to the CDC, there are currently 32 cases of E. coli across 11 states, which have been linked to the consumption of romaine. Thus far, no deaths have been reported, but 13 people have been hospitalized and one person has developed hemolytic uremic syndrome, a type of kidney failure.
  • Additionally, the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency are also coordinating with US agencies to investigate a similar outbreak in Canada. PHAC has identified 18 people sick with the same strain across Ontario and Quebec.
  • The current outbreak E. coli strain is the same as the one identified in a 2017 outbreak, which was linked to leafy greens. However, the strain is not related to the E. coli outbreak from early 2018. Our readers may remember, we’ve previously discussed that outbreak, which was declared officially over on June 28 and may have been caused by concentrated animal feeding operations in the Yuma, Arizona area.
  • The FDA is conducting a traceback investigation to determine the source of the romaine outbreak. FDA and state authorities are also conducting laboratory analysis of romaine lettuce samples potentially linked to the current outbreak. Until a source is determined, authorities recommend people do not eat romaine lettuce.

 

The Daily Intake will return Monday, November 26. We extend our best wishes to those of you celebrating the Thanksgiving holiday.

  • 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 that can be approved by FDA : (1) authorized health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims. A “qualified health claim” must be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim.
  • On November 19, 2018, FDA announced that it intends to exercise enforcement discretion for the use of a qualified health claim suggesting that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease. Responding to a petition filed by Corbion Biotech, Inc., the Agency noted that while there is credible evidence to support a qualified health claim for oleic acid, the evidence does not meet the more rigorous “significant scientific agreement” standard required by an authorized health claim. Therefore, FDA stated that it intends to exercise enforcement discretion for the following qualified health claims:
    • “Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid).”
    • “Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should replace fats and oils higher in saturated fat and not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid.”
  • In a statement about the qualified health claim, FDA Commissioner Scott Gottlieb explained that “modernizing and prioritizing new claims on food labels” is part of the Agency’s Nutrition Innovation Strategy. (For more information on FDA’s Nutrition Innovation Strategy, click here.)