FDA and FTC Send Warning Letter for Marketing Unapproved Drugs and Dietary Supplements Containing CBD

  • On October 10, the FDA and FTC sent a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved drug products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), Parkinson’s and Alzheimer’s disease, among other conditions.
  • As described in the warning letter, the FDA and FTC stated that the company used its website, online store, and social media sites to make unfounded claims about its CBD products, some of which were also unlawfully marketed as dietary supplements. Examples of the claims include:
    • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
    • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
    • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
    • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
  • Additionally, the FTC was concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. Under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence that substantiates the claims made.
  • The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. However, as our readers may recall, in July 2019, the FDA announced their commitment to evaluating potential regulatory pathways for CBD products to be lawfully marketed, and that the Agency would report their progress by early fall 2019. As of today’s blog, the Agency has yet to advise on such pathways. Nonetheless, in a press release related to the October 10 warning letter, Acting FDA Commissioner Ned Sharpless, M.D. stated that the CBD-related warning letters “should send a message to the broader market about complying with FDA requirements.” Additionally, he noted that as the Agency continues to examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains top priority.  We will continue to report on developments that impact the use of CBD in FDA regulated products.

Lawmaker Calls for FDA to Respond to Report on Toxic Metals in Baby Food

  • Toxic metals – such as arsenic, lead, cadmium, mercury and others – occur naturally and as environmental pollutants in air, water and soil and they enter the food supply when plants take them up as they grow. The Food and Drug Administration (FDA) actively monitors the levels of these metals in food and established a Toxic Elements Working Group in 2017 to analyze the data and coordinate FDA’s response. Toxic elements are not necessarily more prevalent in food today than in previous generations, but increasingly sensitive detection methods and the wealth of available data may offer ways to reduce the intake of toxic metals, especially by uniquely vulnerable populations such as infants and toddlers.
  • According to its website, Healthy Babies Bright Futures (HBBF) is an alliance of nonprofit organizations, scientists and donors that designs and implements outcomes-based programs to measurably reduce babies’ exposures to toxic chemicals in the first 1,000 days of development. HBBF’s report, What’s in my baby’s food, released October 17, 2019, identifies the levels of lead, arsenic, cadmium, and mercury found in 13 types of baby food: puffs/snacks, teething biscuits, infant rice cereal, other (non-rice) infant cereal, fruit, vegetables, mixed fruits and vegetables, meats, meals, infant formula, apple juice, 100% fruit juice, and other (non-juice) drinks. As widely covered in the popular press, HBBF reported that 94% of the baby foods contained lead, 73% contained arsenic, 75% contained cadmium, and 32% contained mercury, while 26% of the baby foods contained all four toxic metals.
  • Heavy metals may be a future action item for at least one lawmaker. Senator Chuck Schumer (D-NY) is reportedly calling for FDA to respond to HHBF’s report and to establish standards for heavy metals. The HHBF report urges FDA to:
    • Set health-protective standards for heavy metals, prioritizing foods that offer FDA the greatest opportunity to reduce exposure, considering additive effects of the multiple metals detected in foods, and explicitly protecting against neurodevelopmental impacts.
    • Strengthen and finalize standards for arsenic in apple juice and infant rice cereal, and expand the range of foods covered. HBBF supports recommendations for a 3-ppb inorganic arsenic standard and 1-ppb lead standard that apply to all fruit juice, and a health-protective standard for arsenic in infant rice cereal and all other rice-based foods.
    • Implement a proactive testing program for heavy metals in foods consumed by babies and toddlers, similar to the Consumer Product Safety Commission’s program for children’s toys (CPSC 2019).
    • Ensure lead is not present in food contact materials where it could get into food.
    • Establish a goal of no measurable amounts of cadmium, lead, mercury, and inorganic arsenic in baby and children’s food, in recognition of the absence of a known safe level of exposure, and work with manufacturers to achieve steady progress.
  • FDA has not commented on HHBF’s recommendations.

USDA Announces Renewal of Substance Exemptions in the National Organic Program

  • As previously discussed on this blog, there is a National List of Allowed and Prohibited Substances (the “National List”) for synthetic and nonsynthetic nonagricultural (nonorganic) substances that may be used in organic handling, and nonsynthetic substances prohibited from use in organic farming under the National Organic Program (NOP) administered by the United Stated Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS).  The National List is codified at 7 CFR 205.601 through 205.606 and items on the list must be reviewed at least every five years.  The National Organic Standards Board (NOSB) is responsible for reviewing the substances and providing a recommendation to the Secretary of USDA to either renew or remove (only available if 2/3 or more of the members of the NOSB vote to remove at a meeting with a quorum of members) substances on the National List.  AMS, which has been delegated the authority to manage the National List by the Secretary, considers the NOSB recommendation and public comment before making its decision. For more background, see our blog posts here, here, here, here and USDA resources
  • The NOSB held public meetings to discuss the substances that were sunsetting in 2019 on April 19-21 and October 31 – November 2, 2017.  There were five substances reviewed that have already been addressed by AMS (see our blog posts here and here) and on October 8 AMS announced that 24 additional substances on the National List would be renewed without change.  The substances include:
    • Chlorine materials: Calcium hypochlorite, Chlorine dioxide, Sodium hypochlorite (synthetic substance permitted in organic crop production and organic livestock production)
    • Herbicides, soap-based (synthetic substance permitted in organic crop production)
    • Mulches: Biodegradable biobased mulch film (synthetic substance permitted in organic crop production)
    • Boric acid (synthetic substance permitted in organic crop production)
    • Sticky traps/barriers (synthetic substance permitted in organic crop production)
    • Coppers, fixed (synthetic substance permitted in organic crop production)
    • Copper sulfate (synthetic substance permitted in organic crop production and organic livestock production)
    • Humic acids (synthetic substance permitted in organic crop production)
    • Vitamins, C, and E (synthetic substance permitted in organic crop production)
    • Lead salts (nonsynthetic substances prohibited from use in organic crop production)
    • Tobacco dust (nicotine sulfate) (nonsynthetic substances prohibited from use in organic crop production)
    • Glucose (synthetic substance permitted in organic livestock production)
    • Tolazoline (CAS # 59-98-3) (synthetic substance permitted in organic livestock production)
    • Attapulgite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Bentonite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Diatomaceous earth (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Nitrogen (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Sodium carbonate (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Acidified sodium chlorite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Carbon dioxide (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Magnesium chloride (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Sodium phosphates (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Casings (Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic”)
    • Pectin (Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic”)
  • AMS is also reviewing the NOSB recommendations to remove vitamin B1, oxytocin, procaine, and konjac flour from the National List.  Such changes will be announced in a separate rule.

Mexico’s Lower House Passes Front-of-Pack Labeling Bill

  • On October 11, Mexico’s lower legislative house passed a bill that would require manufacturers to place front-of-pack (FOP) warning labels on food high in sugar, sodium, or saturated fat.  The bill was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) and consists of a draft amendment to the General Labelling Specifications for Prepackaged Foods and Non-Alcoholic Beverages-Commercial and Health Information.
  • Mexico’s current FOP labeling provides information on the quantities of and percent daily values for saturated fat, total fat, total sugars, sodium, and calories in foods.  The proposed amendments would require manufacturers to place an octagonal warning symbol, stating “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.”  While FOP labeling is increasingly common in Central and South American countries, a unique provision of the Mexico bill is that it would also include a warning for foods containing artificial sweeteners, stating “Contains Sweeteners – Avoid in Children.”
  • Those interested in commenting on the draft amendment have 60 calendar-days to submit comments. The bill will now go to the Senate, where it is expected to pass, and then to President Andres Manuel Lopez Obrador, who has expressed support for the bill.

Pork Workers Union Sues USDA Over New Swine Slaughter Inspection System

  • The United Food and Commercial Workers (UFCW) International Union, together with Public Citizen Litigation Group, filed a federal lawsuit to stop the USDA’s new swine slaughter modernization rule that eliminates line speed limits in pork slaughter plants, and ultimately gives inspection responsibility to the slaughter plants instead of USDA inspectors.  As we have previously covered on this blog, in September, USDA published the final New Swine Slaughter Inspection System (NSIS), which established that hog slaughter plants may voluntarily join a new inspection system whereby establishment personnel would be responsible for sorting and removing unfit animals and identifying defects before FSIS inspection. FSIS online inspectors would be reduced to a maximum of three per line per shift. The rule also revokes maximum line speeds in processing plants.
  • UFCW is the largest private sector union in the United States, and represents 30,000 pork workers who handle 71% of all hogs slaughtered and processed in the US. The lawsuit alleges that the new NSIS rule violates the Administrative Procedures Act because it is not backed by reasoned decision-making. Additionally, the suit alleges that the rule will hurt pork workers across the country. According to the UFCW, even at current line speeds, swine slaughter and processing workers face risks that can lead to severe injury, illness, and death. Indeed, meatpacking workers are already injured at 2.4 times the rate of other industries.
  • The UFCW suit also alleges that the new rule will significantly impact food safety. For instance, the new rule includes no requirement or funding to train plant employees on inspection techniques that were previously performed by USDA inspectors. UFCW President Marc Perrone stated that “[t]his new rule would also dramatically weaken critical protections that Americans depend on to be able to select safe, healthy food to feed their families every day. The safety of America’s food and workers is not for sale and this lawsuit seeks to ensure this dangerous rule is set aside and these companies are held accountable.”

Suit Over ‘No Preservatives’ Capri Sun Label Tossed

Kraft Dodges Suit Over ‘No Preservatives’ Capri Sun Label (subscription to Law360 required)

  • A proposed class action, filed in the Northern District of Illinois on October 25, 2018, against Kraft Heinz Food Co. accused the company of falsely advertising its Capri Sun juice as containing “no preservatives” when in fact it contains citric acid. Tarzian et al v. Kraft Heinz Food Company, Case No. 1:18-cv-07148. The complaint alleged that the representation that Capri Sun beverages contain “No Artificial Coloring, Flavors, or Preservatives” is unfair and deceptive advertising as the beverages contain a well-known preservative, citric acid.
  • In an order filed on October 10, 2019, U.S. District Judge Charles P. Kocoras dismissed the lawsuit and found that while the plaintiffs allege practices commonly used to manufacture citric acid throughout the industry, plaintiffs failed to draw a connection between the common industry practice and the actual practice used by Kraft.
  • This dismissal follows a dismissal of a similar matter in California federal court in 2015. Osborne v. Kraft Heinz Group, Inc., Case No. 3:15-cv-02653. In that case, plaintiffs accused Kraft of mislabeling Capri Sun drinks as “all natural” when they allegedly contained synthetic ingredients, including citric acid and natural flavor. In a hearing on the defendant’s motion to dismiss, U.S. District Judge Vince Chhabria found that plaintiff did not know whether the citric acid used in Capri Sun’s drinks was natural or synthetic. The judge ultimately granted Kraft Heinz’s motion to dismiss with leave to amend the complaint. The plaintiff never filed an amended complaint.

Trade Associations Send Letter to All Members of Congress Urging Action on CBD in Dietary Supplements

  • On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations representing the dietary supplement and natural products industries, sent a letter to all 535 members of Congress urging them to pass legislation that would make cannabidiol (CBD) derived from hemp a legal dietary ingredient for use in dietary supplements.

 

  • The letter requests that Congress carve out a statutory pathway for the lawful introduction of CBD-containing supplements into the marketplace. Specifically, the proposed law would create a limited waiver of § 201(ff)(3)(B) of the Food, Drug, and Cosmetic Act (FDCA), which FDA has previously used to support its position that CBD may not be used in dietary supplements because it is an active ingredient in an FDA-approved drug and has been the subject of substantial clinical investigations. CBD derived from hemp would be exempt from this section, provided that the products meet established safety and quality criteria and comply with all other provisions of the FDCA. The letter also calls for increased funding on top of the $2 billion provided to FDA to address the issue of hemp-derived CBD in the FY 2020 Agriculture and Related Agencies Appropriations bills.

 

  • In the wake of rapidly increasing sales of hemp-derived CBD products, Congress has repeatedly pressured FDA to act quickly in establishing a regulatory framework for CBD. Thus far, FDA has stated that it is exploring additional regulatory pathways for CBD products, but that this process is likely to take 3 to 5 years. FDA maintains that dietary supplements containing hemp-derived CBD are illegal under the FDCA. Meanwhile, the Federal Trade Commission has stepped up enforcement against CBD products that are promoted via health-related claims.

California Chamber of Commerce Challenges Proposition 65 Warnings for Acrylamide

  • On October 7, 2019, the California Chamber of Commerce (“CalChamber”) filed suit in federal court against the California Attorney General, Xavier Becerra, to block the state from enforcing Proposition 65 warning requirements on foods containing acrylamide.  Acrylamide is a naturally occurring compound that develops when starches and sugars are cooked at high temperatures.  According to California’s Office of Environmental Health Hazard Assessment (OEHHA), it is present in foods including “French fries, potato chips, fried and baked snack foods, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, roasted grain-based coffee substitutes, prune juice, breakfast cereals, crackers, some cookies, bread crusts, and toast.”
  • CalChamber is arguing that warnings for acrylamide constitute false and misleading compelled speech that violates the First Amendment of the United States Constitution because there is a lack of reliable scientific evidence suggesting a causal relationship between acrylamide in food products and cancer risk.  CalChamber also argues that Proposition 65 warnings for acrylamide will result in over-warning, which will dilute the effectiveness of warnings on other products that do pose a risk of harm to consumers.
  • Acrylamide has been on the Proposition 65 chemicals list since 1990 but was not a focus for enforcement in food products until recent years.  CalChamber hopes that this lawsuit will reduce unnecessary fear for consumers and reduce litigation threats for businesses.

California’s Proposition 12 Challenged on Constitutional Grounds

  • As our readers may know, in November 2018, California voters passed a ballot initiative known as Proposition 12, which establishes new standards for confinement of certain farm animals and bans the sale of products that do not comply with the new confinement standards. Specifically, Proposition 12 requires that all eggs sold in the state come from cage-free hens by 2022, and it also bans the sale of pork and veal in California from farm animals raised in cages that do not meet new minimum size requirements. Therefore, farmers across the country who sell eggs, veal, and pork in California will be required to comply with Proposition 12.
  • In a lawsuit filed on October 4, 2019, the North American Meat Institute (NAMI) argues that Proposition 12 impedes interstate commerce and violates the Constitution’s commerce clause by banning the sale of pork and veal imported from other States unless they comply with Proposition 12’s animal-confinement standards. “This case is about whether California can insulate its farmers from out-of-state competition and project is agricultural regulations beyond its borders…” NAMI requests the U.S. District Court for the Central District of California stop implementation and enforcement of the law and issue a declaration that these requirements are unlawful under federal law.
  • We will continue to monitor developments in this challenge to California’s Proposition 12.

FDA Publishes List of Records Required Under FSVP

  • As our readers may know, the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP compliance date began May 30, 2017, however there are a range of compliance dates according to a number of considerations.
  • Under the program, importers are required to develop, implement, and maintain a FSVP which includes verification activities and records of those activities for each imported food from each foreign supplier. During an FSVP inspection, the FDA investigator will review the importer’s records to determine their compliance with the FSVP regulation.
  • To help importers determine the FSVP records they should develop and maintain, the FDA has made available a list of records required by the FSVP regulation. The list of records is organized based on the sections of the FSVP regulation so that importers can readily determine the required records for the sections that apply to them.  
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