FDA Warns of Illegal Online Pharmacies Sending Fake FDA Warning Letters Instead of Medicines to Would Be Customers

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 FDA warns of imposters sending consumers fake warning letters – Scammers are targeting consumers who have purchased medicines online (July 13, 2018 FDA news release)

  • The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.  Instead of receiving the medicines they paid for, consumers have received fake warning letters, generally addressed to a “Sir/Ma’am.”  The letters allege the order has been intercepted and threaten that “we are still investigating the root of this delivery & necessary legal steps will be taken if we found [sic] out any suspicious activity on your end.”
  • In reality, FDA does not typically take action against individuals purchasing a medicine online.  FDA typically sends warning letters directly to companies and individuals involved in the manufacturing or distribution of FDA-regulated products.  It would be highly unusual for FDA to send any official communication to an individual consumer.
  • FDA cautions of the risks of purchasing medicines from illegal online pharmacies.  Dangers include receiving counterfeit medicines or being the victim of scams such as the current one.  FDA advises that medicine can be purchased online safety by buying only from U.S.-licensed pharmacies that require a prescription.

FDA Publishes Proposed Revision to and Extended Compliance Date for Front of Pack Calorie Declaration for Vending Machines

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  • The Food, Drug, and Cosmetic Act (FDCA) Section 403(q)(5)(H) (located at 21 USC Section 343(q)(5)(H)) requires certain vending machine operators to provide calorie declarations for certain foods sold in their vending machines.  FDA has previously issued a rule implementing this statutory provision – vending machine operators have until July 26, 2018 to provide the calorie disclosure and they may do so using a Front of Pack (FOP) disclosure using letter size that is at least 50% of the largest printed matter on the label.
  • On July 12, 2018, FDA proposed a revision to the rule.  In response to concerns expressed by industry, FDA is considering revising the minimum size requirements for the FOP calorie declaration to 150% of the size of the Net Quantity of Contents Declaration.  Other possible revisions considered were to not require a specific size for the declaration or calorie declaration equal to at least 100% of the Net Quantity of Contents Declaration.
  • FDA also announced that it is extending enforcement discretion regarding type size for the FOP calorie declaration until the rulemaking is complete.  FDA will also push off enforcement of calorie declaration for gum, mints, and roll candy products in packages too small for FOP labeling until at least January 1, 2020 while it considers this issue further.
  • FDA is accepting comments on the proposed rule until September 25, 2018.

FDA Holds Public Meeting to Discuss the Safety of Food Produced Using Animal Cell Cultures

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  • As announced on June 15, 2018, FDA is holding a meeting today to discuss the safety of innovative “cultured” food products (e.g., cultured meat).  The meeting is scheduled to last from 8:30 am to 3 pm EDT and can be streamed on FDA’s website.
  • In a June 18, 2018 Federal Register notice, FDA requested comments in advance of the meeting on the safety of foods produced using animal cell cultures.  FDA specifically requested comments on what considerations should be taken into account when evaluating foods produced by animal cell culture technology, how the technology could have an impact on food safety, how to evaluate the inputs used in this technology, and what how to assess hazards that may be unique to the production of foods using animal cell culture technology.
  • While FDA may be trying to take the lead in terms of federal agencies that will evaluate animal cell culture technology, there is some debate as to whether FDA or USDA should have jurisdiction over cultured meat.  The United States Cattlemen’s Association, for example, appears eager for USDA to handle cultured meat issues, as it has submitted a petition asking USDA to exclude cultured products from the definition of beef and meat.

Philadelphia May Become Second U.S. City to Require Sodium Warnings

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  • At the end of June 2018, the Philadelphia City Council unanimously passed a bill that would require chain restaurants to place a warning label next to menu items that contain 2,300 milligrams (mg) or more of sodium. The warning would apply to printed and electronic menus, menu boards, and food tags, and would feature the following language: “Sodium content higher than daily recommended limit (2,300 mg). High sodium intake can increase blood pressure and the risk of heart disease and stroke.” The Daily Value for sodium is 2,300 mg per day – Daily Values are reference amounts of nutrients to consume or not to exceed each day for adults and children 4 years of age and older, as determined by FDA.
  • The bill was introduced by Philadelphia Councilmember Blondell Reynolds Brown who believes the warning will help consumers make healthy food choices. According to Councilmember Reynolds Brown, “[w]e cannot assume that consumers know the nutritional content of food before they eat.  This legislative measure is another opportunity to promote smart and healthy food choices.  In addition, it is an opportunity to educate our communities about what they are consuming.” And as per the Behavioral Risk Factor Surveillance System and the National Center for Health Statistics Interactive Atlas of Heart Disease and Stroke, Philadelphia has extraordinarily high rates of hypertension and the highest rate of premature death from heart disease of the ten largest U.S. cities.
  • The bill is currently awaiting review by Philadelphia Mayor Jim Kenney, and will become law if signed.  Should the bill be signed into law, Philadelphia will become the second city to require sodium warnings, joining New York City, which passed the nation’s first sodium warning policy in 2015. You can read more about New York City’s sodium warning here.

Expanded FDA Electronic System Now Includes All Exports Lists

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  • The U.S. Food and Drug Authority (FDA) announced the launch of an electronic portal, Export Listing Module (ELM), for receiving and processing requests from FDA- regulated establishments that want to be included on export lists for FDA-regulated food products. By way of background, some foreign authorities require FDA to provide publicly available lists of exporters eligible to ship certain food products to their country. For example, China requires a certification for compliance with relevant standards, laws, and regulations of China for imported milk and milk products, seafood, infant formula, and formula for young children. (See our June 30, 2018 blog for more details.)
  • Currently, FDA has export lists of companies that meet importing country requirements for dairy, infant formula, collagen, gelatin, and seafood products. The expanded ELM will include all exports lists and, therefore, improve efficiency. FDA stated that it will use the information collected through the ELM to review firms’ information and to provide updates to foreign regulatory agencies.
  • On July 9, 2018, FDA began receiving, updating, and processing new requests on current listing information using the ELM for firms exporting seafood and infant formula to China, as well as establishments exporting collagen and gelatin products to the European Union. FDA strongly recommends that companies currently listed for these products submit a new request via the ELM. However, companies that previously submitted requests for inclusion on the dairy exports lists via the previous Dairy Listing Module (DLM) will be able to access these requests via the ELM.
  • Firms exporting milk and milk products, seafood, infant formula, and formula for young children to China may have them removed from China’s lists by the Certification and Accreditation Administration of the People’s Republic of China (CNCA) if they do not provide information through the ELM by June 15, 2019. Therefore, these firms should not delay transitioning to the new ELM.

State Class Action Lawsuit Filed Over ‘Made With Real Ginger’ Claim

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Dr Pepper Hit With Suit Over Real Ginger Campaign – Law360 (subscription to Law360 required)

  • Janet Childers, the named plaintiff in a proposed class action lawsuit in Texas, alleges that labels claiming ‘Made with Real Ginger’ on Canada Dry Ginger Ale are misleading because the product contains no real ginger.  Childers further alleges that the company added only a miniscule amount of ginger flavor extract (200 parts per million) so as not to impact the flavor (produced by artificial ingredients) and for the purpose of marketing the drink as a healthy alternative to soft drinks, despite the ginger ale having the same high sugar content as other sodas.  Childers et al. v. Dr Pepper Snapple Group Inc. et al., case number DC-18-08724, was filed in the District Court of Dallas County, Texas on July 5, 2018.  Childers seeks compensation, punitive damages, and an injunction to prevent Dr Pepper from selling ginger ale with the offending labels.
  • Dr Pepper also faces a federal class action lawsuit in California over the ‘Made with Real Ginger’ claim.  Class certification was granted June 25, 2018 in Jackie Fitzhenry-Russell et al. v. Dr Pepper Snapple Group Inc. et al., case number 5:17-cv-00564, in the U.S. District Court for the Northern District of California.  Another federal class action lawsuit over the ‘Made with Real Ginger’ claim (Webb v. Dr Pepper Snapple Group Inc. et al., case number 4:17-cv-00624, in the U.S. District Court for the Western District of Missouri) was dismissed by the plaintiff voluntarily and without explanation on June 19, 2018.
  • Manufacturers of other products containing only the extract of a touted ingredient should pay close attention to the ‘Real Ginger’ lawsuits.

 

 

Final Comments on USDA’s BE Labeling Rule Debate Disclosure for Highly Refined Foods and Ingredients

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  • The comment period on USDA’s proposed requirements to implement the National Bioengineered Food Disclosure Standard (NBFDS) closed on July 3. As previously reported on this blog, when USDA asked for input prior to drafting the regulation, commenters disagreed on whether highly refined ingredients derived from bioengineered (BE) crops should be disclosed. As a result, in the proposed regulation (see 83 Fed. Reg. 19860-19889), USDA’s Agricultural Marketing Service (AMS) offered two options with respect to labeling highly refined foods and ingredients and requested comments on them.
    • Option 1: Highly refined products are not within the scope of “bioengineering” because they do not contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and, therefore, do not require disclosure as “bioengineered food.”
    • Option 2: The definition of “bioengineering” includes all foods produced from bioengineering, including highly refined products, and, therefore, foods containing highly refined ingredients should be labeled as BE foods.
  • USDA received comments supporting both options. The American Farm Bureau Federation, American Soybean Association, American Sugarbeet Growers Association, National Corn Growers Association, National Cotton Council, US Canola Association,  National Fisheries Institute, and the U.S. Beet Sugar Association were among the groups supporting Option 1. In its comments urging AMS to exclude highly refined ingredients, particularly refined sugar, from the scope of the NBFDS, the U.S. Beet Sugar Association stated, “Creating any presumption, even unintentionally, that beet sugar produced from transgenic sugar beets is different and less desirable than its conventional counterparts or cane sugar is not supported by science, is contrary to the intent of the NBFDS, imposes a costly and discriminatory burden on the industry, and has harmful economic impacts throughout the supply chain.”
  • Groups supporting Option 2 include the Grocery Manufacturers Association (GMA), the American Beverage Association, the American Frozen Foods Institute (AFFI), the American Herbal Products Association, the National Confectioners Association, and SNAC International. In its comments, AFFI reasoned, “Because refined ingredients may contain modified DNA if they are derived from crops on the proposed BE crops list, and because the underlying crop did contain the modified DNA, the resulting foods or ingredients should be subject to disclosure.” AFFI added that “including refined ingredients derived from BE crops would be consistent with consumer expectation.” In a press release about its comments, GMA noted that approximately 90% of U.S. corn, soybean, and beet sugar crops are bioengineered and estimated that excluding refined ingredients from the scope of the mandatory disclosure standard would result in 78% fewer products being disclosed.
  • We will continue to monitor developments on the National Bioengineered Food Disclosure Standard.

FDA Renews Cautions Against Consumption of Kratom Following Conclusion of Salmonella Investigation

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  • Kratom is a botanical substance that grows naturally in Southeast Asia. FDA classifies kratom as an opioid, noting that it is addictive and has been linked to severe health consequences and deaths among users. Nevertheless, the popularity of kratom has grown in recent years despite kratom not being legally marketed as a drug or dietary supplement in the United States. In February 2014, the FDA issued an import alert that allows U.S. officials to detain imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.
  • As reported on this blog, FDA began cracking down on kratom importers with an administrative detention and seizure in January 2016, and escalated enforcement activity two years later with a voluntary recall and destruction announced February 21, 2018 of several kratom products illegally marketed as dietary supplements and May 22, 2018 warning letters against three kratom products making medicinal drug claims.
  • Salmonella risk became a new focus of concern with kratom for FDA with a mandatory recall order (FDA’s first mandatory recall order ever) announced April 12, 2018 against a kratom product associated with salmonellosis. Throughout the year, FDA announced additional kratom recalls due to salmonella contamination of products from multiple different companies and brands.
  • A Statement From FDA on the Ongoing Risk of Salmonella in Kratom Products (July 2, 2018) outlines the scientific basis for FDA’s conclusion that kratom consumption presents a significant risk of exposure to salmonella. According to FDA, salmonella contamination of kratom has probably been occurring at a significant level for some time and is ongoing. A total of 81 samples of kratom were collected and tested as a direct result of FDA’s investigation of 199 cases of salmonellosis linked to kratom consumption as of May 2018 and 42 (52%) were found to be contaminated with salmonella. FDA further found that kratom is grown and harvested mainly under conditions promoting widespread contamination of foodborne pathogens and that further processing steps to manufacture capsules, powders, and herbal remedies do not appear to eliminate microbial contamination.
  • Since FDA considers kratom to be a dangerous and addictive opioid, it is unlikely that any steps to make kratom products safer with respect to microbial contamination would result in reduced FDA enforcement.

FDA Survey of the Cosmetics Industry on Current Manufacturing Practices

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  • The U.S. Food and Drug Administration (FDA) announced yesterday, July 2, 2018, an opportunity for public comment on a proposed survey of the manufacturing practices and standards employed across the cosmetic industry to ensure product quality and safety. The survey is intended to provide the industry with a systematic and detailed study of the current manufacturing practices, a study which, to date, has never been undertaken by FDA.
  • The voluntary survey would collect a variety of data ranging from general company information about the product manufacturer (such as production and volume, approximate revenue, company size), as well as data on the following practices: written procedures and documentation relating to manufacturing, processing, maintenance, and training; buildings and equipment management, including cleanliness, sanitation, pest control practices, and equipment maintenance; materials and manufacturing, including inventory management and standard operating procedures; and quality control/product testing, including scope, quality testing, rejected products or complaint response, and other corrective actions. The comment period will be open until August 31.
  • Some stakeholders and consumer groups have been calling on lawmakers and regulators to reform cosmetics regulations for years, and this initiative could signal that regulatory modifications lie ahead. Five years have passed since FDA issued its draft guidance for Cosmetic Good Manufacturing Practices, which was originally issued on February 12, 1997 and was later revised in April of 2008 and again in June of 2013.

The Daily Intake will return on Thursday, July 5.  We extend our best wishes to those of you celebrating the Independence Day holiday.

California Bans New Soda Taxes until 2030

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  • On June 28, 2018, California Governor Jerry Brown signed AB1838, which prohibits local government agencies from imposing new taxes on “groceries,” which are defined to exclude alcoholic beverages, cannabis products, cigarettes, tobacco products, and electronic cigarettes.  The bill is widely seen as a ban on taxes on sugary drinks in particular.
  • The passage of AB1838 is resulting in the withdrawal of Ballot Measure 17-0051, which was supported by the American Beverage Association and which would have required a super majority (rather than a simple majority) to raise local taxes and fees, regardless of the reason for the tax initiative.
  • The threat of Ballot Measure 17-0051 in terms of funding future social programs outweighed the prospective benefits of new taxes on sugary drinks.  Existing local taxes on sugary drinks in Berkeley, San Francisco, Albany, and Oakland are unaffected, as AB1838 affects only initiatives passed after January 1, 2018.
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