• Dietary supplement manufacturer Confidence USA Inc., located in Port Washington, New York, its president, and its general manager received a permanent injunction on March 4, 2021 from the U.S. District Court for the Eastern District of New York that prevents them from manufacturing, holding, or distributing dietary supplements until further notified by FDA. Confidence USA manufactures and distributes more than fifty dietary supplements under several brands, including Confidence USA, American Best, USA Natural, and the Herbal Store, through Amazon, Walmart, and its own online retail store.
  • The court found that Confidence USA had violated the Federal Food, Drug, and Cosmetic Act by failing to follow the Current Good Manufacturing Practices (CGMPs) for dietary supplements including repeat violations of rules requiring defendants to verify the identity of each dietary ingredient used in their products and verify that their products met certain purity, strength, composition, and contamination limits. To be able to continue their dietary supplement business, Confidence USA must hire an independent expert to assist in remedying the causes for the repeat violations, pass an inspection, and receive FDA’s specific approval to resume operations.
  • By way of background, FDA regulates the packaging and preparation of dietary supplements and their ingredients. The Dietary Supplement CGMPs include rules on quality control, sanitation, and product testing that ensure dietary supplements are processed in a sanitary and safe manner and meet quality standards. Keller and Heckman is experienced in assisting dietary supplement manufacturers with CGMP compliance.
  • Industry groups and the sugar industry have submitted comments to the U.S. Food and Drug Administration (FDA) regarding potential labeling exemptions for certain types of sugars that are not fully metabolized in the human body.  Industry members—including General Mills, Hershey, and Unilever—support FDA’s effort to reassess labeling mandates for sugars.  However, the sugar industry opposes the initiative and is urging FDA to continue requiring that all traditional and non-traditional sugars be declared on the Nutrition Facts Panel (NFP).  Currently, FDA looks at sugar by chemical content rather than by physiological effect; thus, there is currently no difference in the way “non-traditional” sugars like allulose, D-tagatose, and isomaltulose are declared on the NFP.
  • By way of background, in October 2020, FDA issued final guidance on the declaration of allulose on the NFP and Supplement Facts and its caloric content.  The Agency intends to exclude allulose from the Total Sugars and Added Sugars declarations on the NFP and Supplement Facts and use a general factor of 0.4 calories per gram (kcal/g) for allulose when calculating declarations.  Further, the Agency requested comments on the nutrition labeling of non-traditional sugars, which are metabolized differently (i.e., contribute fewer calories), are not associated with dental cavities, and lead to lower blood glucose and insulin levels after a meal than traditional sugars.
  • In its comments, the sugar industry argued that FDA’s proposed change would confuse and mislead consumers by indicating non-traditional sugars are healthier and that it fails to clarify that many non-traditional sugars are synthetically produced.  The sugar industry noted that, if non-traditional sugars like allulose are not listed on labels as sugars, then “allulose manufacturers should be precluded from referring to allulose as a ‘rare sugar’ or a ‘natural sugar.’”  We will continue to monitor any developments.
  • Washington state senators have introduced Senate Bill 5371 (SB 5371), which would impart a tax of $0.0175 per ounce on sugar-sweetened beverages that have more than 20 calories in a 12-ounce serving on beverage distributors. In other words, a 12-ounce can of soda would cost an additional 21 cents. SB 5371 sponsors, State Senators Robinson, Carlyle, Conway, Dhingra, Pedersen, and Saldaña, have said that while other cities around the country have similar type taxes, Washington would be the first state to establish a statewide tax on sweetened beverages.
  • Funds raised from the tax would support public health programs, as well as create a “health equity account” that will hold money to be used to address social determinants of health in disproportionately impacted communities burdened by negative health outcomes, with a particular focus on access to healthy foods, reducing food insecurity, an access to health care, as well as supporting community infrastructure and capacity.
  • SB 5371 is nearly identical to Seattle’s 2018 Sweetened Beverage Tax, however the statewide version imposes a tax on sugary drinks defined as those containing 20 calories or more per 12 ounces, whereas Seattle’s is on sugary drinks with 40 calories or more per 12 ounces. A summary of the Seattle tax, and other citywide sugar-sweetened beverage taxes, can be found here.
  • SB 5371 was introduced on January 28, and was referred to the Senate Health & Long Term Care committee. If passed, SB 5371 would become effective on October 1, 2021. Beginning July 1, 2022, and yearly thereafter, the tax rate would be adjusted to reflect the yearly increase in the consumer price index. Keller and Heckman will continue to monitor any developments.
  • As our many of readers will know, food labels must declare the presence of an ingredient that is or that contains a protein from one of the “major food allergens” as defined in the Federal, Food, Drug and Cosmetic Act (FD&C Act). Currently, eight major food allergens are defined in the FD&C Act: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Absent from this list (and therefore not required to be disclosed in food allergy labeling) is sesame, which 49% of the U.S. population (or approximately 1.6 million people) report having an allergy to.  In November 2020, FDA issued a Draft Guidance indicating that sesame should be voluntarily declared on the food label.  But without legislative action FDA cannot amend the list of major food allergens and officially include sesame as a major food allergen.
  • In response to this issue, on February 22, 2021, the Food Allergy Safety, Treatment, Education and Research (FASTER) Act (H.R.1202) was introduced to the U.S. House of Representatives. Foremost among the bill’s goals is the addition of sesame as a “major food allergen.” Furthermore, the bill would require the Secretary of Health and Human Services to collect data on the prevalence of food allergies and make periodic reports to Congress. The bill also establishes a risk-based scientific process and framework for determining future major food allergens that will trigger mandatory allergen labeling.  The bill was originally introduced to the House in 2019 (see H.R.2117), where it was unanimously passed. And although a similar bill was passed by the Senate (see S.3541), the legislative session expired before the House could consider the revised bill.
  • Keller and Heckman will continue to monitor and report on this bill as it makes its way through the legislative process.

Post Sugary Cereal Buyers Get Ok on $15M False Ad Deal (subscription to Law360 required)

  • On February 24, 2021, a California federal judge tentatively approved a settlement over nutrition-related claims for breakfast cereal whereby Post would establish a $15 million non-reversionary common fund to compensate a nationwide class of consumers who purchased Raisin Bran, Honeycomb, Honey Bunches of Oats, or Waffle Crisps, and Post would  also refrain from using claims including “less processed,” “no high fructose corn syrup,” “natural,” and “wholesome” on boxes of cereal where 10% or more of the calories come from added sugar.  An award for fees, costs, and expenses will be determined in a final hearing scheduled for June 23, 2021.
  • The same team of attorneys also filed proposed class action lawsuits in 2016 with a common lead plaintiff in the Northern District of California against cereals marketed by General Mills and Kellogg involving similar false-advertising claims.  As we previously reported, the case against General Mills was dismissed in June 2020, based on the judge’s finding that plaintiffs could not possibly have been misled because the amount of sugar in the cereals is clearly disclosed on the product labels.  Further, a settlement has not yet been reached in the class action lawsuit against Kellogg (subscription to Law360 required).
  • Although legal results are mixed, and complex issues surround the impact on health of added sugars in a single product and a product’s role in the total diet, nutrition claims that could imply the product is healthy seem risky for foods with added sugars.  Meanwhile, FDA has not indicated how it will act on a citizens petition (discussed here) requesting a regulation to establish disqualifying levels of added sugar that would prohibit the use of a “healthy” claim.
  • New York Governor Andrew Cuomo announced on February 22, 2021 that businesses seeking to operate as cannabinoid hemp processors, retailers, or distributors can now apply for a license through the New York State Department of Health (NYDOH). Any business intending to manufacture, distribute, or sell cannabinoid hemp products in New York State must be licensed.
  • Manufacturers can choose between two types of licenses, which are valid for two years. One license allows processors to extract or isolate cannabinoids, including cannabidiol (CBD), from hemp to create an oil, distillate, isolate, or other product and manufacture the intermediary product into a finished product. The second type of license is for manufacturers that purchase intermediary products and manufacture them into a finished product. Applicants must provide documentation including a description of the products, information about the source hemp, and evidence showing the facility follows current good manufacturing practices. Manufacturers seeking to engage in direct retail sale must separately apply for a retail license.
  • As we have previously reported, the NYDOH published proposed regulations to implement the NY Cannabinoid Hemp Program in October 2020. The rules provide for facility manufacturing guidelines, packaging and labeling standards, and laboratory testing specifications. We will continue to report on developments regarding CBD marketing and manufacturing.
  • On February 16, 2021, the U.S. District Court for the Northern District of Illinois Eastern Division granted final approval of a class action settlement, incentive reward, and attorneys’ fees and expenses that totaled more than $650,000.  The settlement resulted from a 2018 lawsuit where plaintiffs argued that FGF Brands USA Inc. and FGF Brands, Inc. (defendants) made misleading claims regarding the baking process of their various naan products.
  • Plaintiffs filed a lawsuit in 2018 against the defendants who sell naan Indian flatbread, challenging its “tandoor-baked naan” and “tandoor oven-baked to honor 2,000 years of tradition” claims as being false and misleading.  Defendants baked the naan on a conveyor belt in a gas-heated commercial oven, not in traditional tandoor ovens, which are made from clay or stone.  Plaintiffs claimed that there is no substitute for the flavor imparted by baking naan with a traditional stone or clay oven and that the defendants misled plaintiffs into believing that the baking process was devoid of automation or machinery and of a higher quality than mass-produced naan breads.
  • Defendants also are facing legal action over similar claims in Canada where plaintiffs filed a complaint alleging that it is deceptive for the defendants to equate the company’s conventional oven to a tandoor oven.  The case is an example of a relatively rare challenge of a food preparation claim, outside of the “natural” claim context.
  • On February 19, a California federal judge agreed to dismiss a proposed class action lawsuit that alleged Hostess Brands Inc. misled consumers into believing its carrot cake mini doughnuts contained actual carrots. U.S. District Judge Sallie Kim granted the motion after the parties filed a joint stipulation which dismissed the plaintiff’s claims with prejudice, and without prejudice to all putative class member claims. Neither the stipulation nor the order stated the reason for the dismissal.
  • The lawsuit was filed on August 25, 2020 by Elena Lauchung-Nacarino and alleged that Hostess failed to disclose that no real carrots were used as ingredients in the mini doughnuts. Lauchung-Nacarino argued that consumers expect carrot cake to contain a substantial amount of real carrots, and that the Hostess mini doughnuts are the only major carrot cake product without any real carrots.
  • As previously reported, Hostess responded to the complaint by arguing that “carrot cake” refers to the taste of the doughnuts, rather than the presence of carrots as an ingredient, and that the absence of carrots in the ingredient statement, along with there being no picture of carrots on the label, shows there are no actual carrots in the pastries. Further, Hostess argued that plaintiff’s allegations are undermined by the fact that plaintiff first bought the doughnuts in 2019, when the product label had a disclaimer saying “naturally and artificially flavored carrot cake mini donuts.”
  • We have previously blogged about the fallout from a Congressional report on the level of heavy metals in baby foods, including class-action lawsuits against Gerber Products Co. and Plum, PBC (see blog post) as well FDA’s response to the report (see blog post).
  • Unsurprisingly, these lawsuits were just the beginning of a trend and in recent weeks a series of new class-actions have been filed, each alleging similar consumer deception claims relating to the presence of heavy metals in baby foods.
    • A class action was filed against Gerber Products Co. and Hain Celestial Group (Hain) in the North District of Illinois for allegedly omitting and concealing the presence of dangerous levels of heavy metal in the baby food products they sell.
    • Another class action was filed in the Northern District of Illinois against Hain for allegedly misleadingly marketing baby foods such as Earth’s Best Organic Banana Raspberry & Brown Rice Fruit & Grain Puree as healthy and free of dangerous substances.
    • Two class-action lawsuits were filed in the North District of New York (see here and here) against Beech-Nut Nutrition Co. for allegedly misrepresenting Beech-Nut baby foods are “real food for babies” and failing to disclose the presence of dangerous levels of heavy metals.
    • A class-action lawsuit was filed against Nurture, Inc. in the Southern District of New York for allegedly misleadingly marketing Happy Baby Superfood Puffs as healthy and nutritious for babies and failing to disclose the presence of heavy metals.
  • Given the recent filings, we have not yet seen briefing or any judicial decisions on the merits of the claims. Keller and Heckman will continue to monitor and report on these class-action lawsuits against baby food manufacturers as well as any other updates regarding the response to the Congressional report.

 

  •  FDA will evaluate claims and other information on a dietary supplement’s website to establish the product’s “intended use.”  In general, a dietary supplement is allowed to make claims about having an effect on the “structure” or a “function” of the human body.  If FDA finds that the product is intended for use in the cure, mitigation, treatment, or prevention of disease, it will be deemed a “drug” under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).  FDA routinely takes enforcement action against such unapproved new drugs.
  • In a February 18, 2021 Constituent Update, FDA announced that it had issued warning letters to 10 companies for illegally selling dietary supplements, containing a variety of ingredients, that all claim on their websites, as well as their Amazon product pages in some cases, to cure, treat, mitigate, or prevent depression and other mental health disorders as follows:
    • ProHealth Inc. for Full Spectrum™ St. John’s Wort Extract41T for claims involving anxiety and mild-to-moderate depression;
    • Dr. Garber’s Natural Solutions for Dr. Garber’s Depression Relief for claims involving depression and postpartum depression;
    • FDC Nutrition Inc. for Inositol 100% Pure Free Form for claims involving anxiety, blood sugar control, insulin sensitivity, and fertility in women;
    • Blossom Nature, LLC for products containing St. John’s Wort with claims including “St. John’s Wort is effective as prescribed antidepressants but with no side effects;”
    • Native Remedies dba Silver Star Brands for MindSoothe Drops and MindSoothe Capsules with claims involving depression, insomnia, loss of appetite, binge eating, overeating, “loss of interest in activities that are normally enjoyable,” and “difficulty concentrating, remembering details, and making decisions;”
    • Wholesome Wellness for its Natural Anxiety & Depression Relief product with claims involving “7 healing herbs” that act as a “natural antidepressant,” including Gotu Kola (wound healing and disease prevention), Rhodiola Root (depression and anxiety), St. John’s Wort (mild-to-moderate depression), Ashwagandha Root (anxiety and depression), Lemon Balm Leaf (a “range of medical disorders,” anti-inflammatory compounds, antithrombotic properties), Ginkgo Leaf (to cure diseases, protects against neuronal damage), and Eleuthero Root (diabetes, cognitive disorders, and frequent colds);
    • SANA Group LLC for Sleep Sana “Sleep Drops” and “Sleep Shots” products claiming to contain ingredients for treating various diseases and symptoms, including GABA (anxiety, attention deficit hyperactivity disorder (ADHD), blood pressure, pain), L-Tryptophan (insomnia, sleep apnea, depression, anxiety, facial pain, premenstrual dysphoric disorder (PMDD), ADHD, Tourette’s syndrome), Valerian (sleep disorders), and Melatonin (seasonal affective disorder (SAD), “winter depression”);
    • Mountain Peak Nutritionals for Mood Support, which the website says contains ingredients such as 5-hydroxytryptophan (5-HTP) (“increases serotonin levels,” “equal effectiveness compared to drugs like Prozac, Paxil, and Zoloft”), B-complex vitamins (“often shown to be deficient in depressed patients”), ginkgo extract (“antidepressive effects”), and St. John’s Wort (“just as effective as pharmaceutical antidepressants in alleviating symptoms of mild to moderate depression, and with very few side effects”);
    • Lifted Naturals for Mood Boosting Probiotic and claims for “PREBIOTIC, GOS– the ONLY prebiotic that’s been proven to help with anxiety,” and treatment of postpartum depression; and
    • Enlifta LLC for “Enlifta Mood Elevator,” a “doctor designed” “antidepressant” and “Enlifta Anxiety” involving claims for “7 proven ingredients that remedy severe anxiety,” including Chamomile Flower (anti-inflammatory), English Lavender Flower Powder (insomnia and anxiety), and Passion Flower Herb Powder (“One study showed it worked as well as a common prescription medication for treating anxiety, but had fewer short-term side effects”).
  • FDA’s February 18, 2021 letters note that depression and other diseases are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner and, therefore, it is impossible to write adequate directions for a layperson to use the products safely for the intended purposes.  To reduce the risk of potential FDA enforcement action, all dietary supplement manufacturers should ensure that they only make appropriate structure/function claims for their products.