Corbett and Dobbs v. Pharmacare

California and Missouri consumers who, while in California or Missouri, purchased certain Sambucol Black Elderberry Dietary Supplements sued Pharmacare U.S., Inc. (“Defendant”), alleging that Defendant violates California and Missouri consumer protection statutes and breaches express and implied warranties by selling certain Sambucol Dietary Supplements without disclosing on the product label or packaging that they contain a new dietary ingredient that has not been approved by the federal Food and Drug Administration (the “NDI Claim”). Dietary supplements are regulated under the Federal Food, Drug, and Cosmetic Act (“FDCA”). The FDCA defines a “dietary supplement” as a “product (other than tobacco) intended to supplement the diet” that contains one or more of the following: (1) vitamins; (2) minerals; (3) herbs or other botanicals; (4) an amino acid; (5) a supplement meant to increase total dietary intake; or (6) a concentrate, metabolite, constituent, extract, or combination of any of the listed ingredients.” 21 U.S.C. § 321(ff)(1). The FDCA does not require FDA approval of dietary supplements before they are sold. However, if a manufacturer wants to market dietary supplements that contain a dietary ingredient that were not marketed in the United States as a dietary supplement before October 15, 1994, they must notify the Food and Drug Administration (“FDA”) about these “new dietary ingredients” before marketing their products. 21 U.S.C. § 350b. But if the “new dietary ingredient” has been present in the global food supply as an ingredient in conventional food, without chemical alteration, no notification is required. Ibid. Failure to notify the FDA of a “new dietary ingredient” may result in the FDA deeming any dietary supplement containing that ingredient to be adulterated under the FDCA. Ibid.

In their lawsuit, Plaintiffs alleged that the elderberry extract in Defendant’s Sambucol Dietary Supplements is a “new dietary ingredient” requiring FDA notification, which Defendant failed to provide to the FDA. Plaintiffs claim that by not disclosing this on its product’s labels, Defendant violates California and Missouri consumer protection statutes, breaches its express warranty that the Sambucol Dietary Supplements are a “dietary supplement,” and breaches implied warranties of merchantability.

Additionally, California consumers allege that Defendant violates California consumer protection statues and breaches express and implied warranties through the use of labeling claims that falsely or deceptively imply that certain Sambucol Dietary Supplements can mitigate or prevent disease, when they cannot (the “Implied Disease Claim”). Under the FDCA, dietary supplement labels or labeling cannot contain statements expressly or implicitly claiming to diagnose, mitigate, treat, cure or prevent disease. 21 U.S.C. 343(r)(6). “For purposes of 21 U.S.C. 343(r)(6), a ‘disease’ is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension) ....” 21 C.F.R. § 101.93(g). Plaintiffs allege that the statements “supports immunity,” “scientifically tested,” and “virologist developed,” appearing on the labels of certain Sambucol Dietary Supplements, when considered collectively, violate the FDCA and falsely and deceptively imply that these products can mitigate or prevent disease, when they cannot, in violation of California’s Unfair Competition Law, False Advertising Law and Consumer Legal Remedies Act, and in breach of express and implied warranties.

The lawsuit seeks restitution or damages (i.e., money) for all qualifying California and Missouri consumers who purchased the Sambucol Dietary Supplements.

Defendant denies all of the claims and allegations made in the lawsuit and the Court has yet to decide the merits of the parties’ claims. The Court has not decided whether Defendant has in fact violated the law. The sole purpose of Notice is to inform potential Class Members of the lawsuit so that they can make an informed decision as to whether they should participate in or opt out of this Class Action. There is no money available now and no guarantee that there will be.

The Honorable James E. Simmons, Jr., United States District Court Judge for the Southern District of California, has approved Rachel Soffin, Nick Suciu III, and Trenton R. Kashima, of Milberg Coleman Bryson Phillips Grossman PLLC as counsel for the following Classes:

• California NDI Claim Class: All persons who, from January 21, 2017 to March 29, 2024, while in California, purchased Defendant’s Sambucol Black Elderberry Original Syrup, Sambucol Black Elderberry Advanced Immune Syrup, Sambucol Black Elderberry Sugar Free Syrup, Sambucol Black Elderberry Syrup for Kids, Sambucol Black Elderberry Gummies, Sambucol Black Elderberry Gummies for Kids, Sambucol Black Elderberry Advanced Immune Capsules, Sambucol Black Elderberry Effervescent Tablets, Sambucol Black Elderberry Chewable Tablets, Sambucol Black Elderberry Pastilles (Throat Lozenges), Sambucol Black Elderberry Daily Immune Drink Powder, and Sambucol Black Elderberry Infant Drops for personal or household use and not for resale.
• California Implied Disease Claim Class: All persons who, from January 21, 2017 to March 29, 2024, while in California, purchased Defendant’s Sambucol Black Elderberry Original Syrup (only 4 oz and 7.8 oz sizes), Sambucol Black Elderberry Sugar Free, Sambucol Black Elderberry Syrup for Kids, Sambucol Black Elderberry Effervescent Tablets, Sambucol Black Elderberry Chewable, Sambucol Black Elderberry Pastilles, Sambucol Black Elderberry Daily Immune Drink Powder, and Sambucol Black Elderberry Advanced Immune Syrup for personal or household use and not for resale.
• Missouri NDI Claim Class: All persons who, from January 21, 2016 to March 29, 2024, while in Missouri, purchased Defendant’s Sambucol Black Elderberry Original Syrup, Sambucol Black Elderberry Advanced Immune Syrup, Sambucol Black Elderberry Sugar Free Syrup, Sambucol Black Elderberry Syrup for Kids, Sambucol Black Elderberry Gummies, Sambucol Black Elderberry Gummies for Kids, Sambucol Black Elderberry Advanced Immune Capsules, Sambucol Black Elderberry Effervescent Tablets, Sambucol Black Elderberry Chewable Tablets, Sambucol Black Elderberry Pastilles (Throat Lozenges), Sambucol Black Elderberry Daily Immune Drink Powder, and Sambucol Black Elderberry Infant Drops for personal or household use and not for resale.

The Court has not decided the merits of the claims in this case and a trial has not been scheduled. There is no guarantee of success and the form and type of relief available to the members of the class, if any, remains to be decided by the Court. However, your rights may be affected by the action, and you now have a choice to make.

Your Legal Rights and Options in This Lawsuit

Ask to Be Excluded

The deadline to exclude yourself from this case was October 6, 2024.

Do Nothing

Stay in this lawsuit and await the outcome. You share in possible benefits and give up right(s) to sue. By doing nothing, you retain the possibility of receiving a partial refund for the relevant Sambucol Black Elderberry Dietary Supplements that you purchased within the above stated time period or such other benefits that may come from a trial or a settlement but you will be bound by the decisions of the Court and give up your individual right to sue on your own about the same legal claims in this lawsuit.