Sambucol Black Elderberry Supplements Break FDA Rules Class Action

With Covid-19 raging around the country, sales of “immune support” dietary supplements have been growing astronomically. Makers of products containing elderberry have benefitted. But the complaint for this class action alleges that PharmaCare US, Inc. violates the law, both because of the claims made for its elderberry products and because its elderberry extract “does not meet the definition of a dietary ingredient” under the Food, Drug, and Cosmetic Act (FDCA).

The National Class for this action is all persons in the US who bought the products at issue for personal use and not for resale. California, Massachusetts, and Missouri Subclasses have also been defined, for person in those states who bought the products.

The products at issue include the following:

  • 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
  • Sambucol Black Elderberry Infant Drops

The Dietary Supplement Health and Education Act (DSHEA) of 1994 set up a new framework for the contents, safety, labeling, making, and marketing of dietary supplements. Under this law, if a dietary ingredient was not, by 1994, “present in the food supply … in the same chemical form that you plan to use in your dietary supplement,” then the FDA must be notified.

The complaint alleges that PharmaCare’s elderberry extract does not meet this requirement, and that the company did not give the FDA the required notice of the new dietary ingredient (NDI). “Dietary supplements that contain undisclosed NDIs[,]” the complaint says, “are considered adulterated for purposes of the FDCA.”

Also, the complaint alleges that PharmaCare makes claims that “are either explicitly or implicitly claiming to mitigate or prevent disease.” Substances that do that are considered to be drugs and they must therefore go through the FDA drug approval process. PharmaCare presents the product as being “Scientifically tested” and developed by a virologist. The complaint alleges that consumers would reasonably believe that Products developed by a ‘Virologist’ would have the ability to mitigate, treat, cure, or prevent a disease or diseases, specifically viruses.”

The packaging of the products also claims that the elderberry extract “provides strong immune system support to help you and your family stay healthy…” Some of the products even have the word “Immune” as part of their name. The company’s website FAQ says elderberry is “used in traditional remedies for colds, coughs, and upper respiratory infections.”

According to the complaint, even the company name—PharmaCare—suggests that its products are drugs.

Finally, the complaint says that the products have not been scientifically tested

Article Type: Lawsuit
Topic: Consumer

Most Recent Case Event

Sambucol Black Elderberry Supplements Break FDA Rules Complaint

February 25, 2021

With Covid-19 raging around the country, sales of “immune support” dietary supplements have been growing astronomically. Makers of products containing elderberry have benefitted. But the complaint for this class action alleges that PharmaCare US, Inc. violates the law, both because of the claims made for its elderberry products and because its elderberry extract “does not meet the definition of a dietary ingredient” under the Food, Drug, and Cosmetic Act (FDCA).

Sambucol Black Elderberry Supplements Break FDA Rules Complaint

Case Event History

Sambucol Black Elderberry Supplements Break FDA Rules Complaint

February 25, 2021

With Covid-19 raging around the country, sales of “immune support” dietary supplements have been growing astronomically. Makers of products containing elderberry have benefitted. But the complaint for this class action alleges that PharmaCare US, Inc. violates the law, both because of the claims made for its elderberry products and because its elderberry extract “does not meet the definition of a dietary ingredient” under the Food, Drug, and Cosmetic Act (FDCA).

Sambucol Black Elderberry Supplements Break FDA Rules Complaint
Tags: Deceptive Advertising, Deceptive Labels, Does Not Meet FDA Supplement Requirements, Drug-Like Claims