Substantiation – Shehadeh Giannamore, PLLC

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District Court sides with Industry on Dietary Supplement Substantiation

FDA, FTC Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Structure-Function Claims, Substantiation

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. The 2007 Consent Decree prohibited Bayer from “making any claim about the performance or efficacy of any dietary supplement, multivitamin or weight-control product unless, at the time Bayer makes the claim, the company possesses competent and reliable scientific evidence to support the claim.” The current decision originates from a motion for an order to show cause filed by the Department…

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FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

FDA, FTC Dietary Supplements, Disease Claims, Drugs, FDA, FTC, Labeling, Substantiation, Warning Letters

On September 23, 2014, the U.S. Food & Drug Administration ("FDA"), in conjunction with the Federal Trade Commission ("FTC"), issued a Warning Letter to Natural Solutions Foundation in Newton, New Jersey. FDA representatives allege the FDA warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic Act by promoting the use of several products to cure, treat, mitigate, or prevent disease. According to the letter, Dr. Rima Laibow promoted Nano Silver as a "natural therapy" or "cure" for the Ebola virus. Additionally, Laibow's website contained claims referring to the product as…

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FTC Prevails Against Marketers of Medical Foods

FDA, FTC Advertising, Disease Claims, FDA, FTC, Substantiation, Warning Letters

On March 7, 2014, the Federal Trade Commission (“FTC”) reported that the Agency had prevailed in federal court in its action against the Wellness Support Network. In particular, the U.S. District Court for the Northern District of California entered a final judgment, finding that Wellness Support Network had violated Section 5 of the Federal Trade Commission Act (“FTCA”) by making claims about its products that were considered false and/or unsupported by scientific evidence at the time the claims were made. As part of its judgment, the Court ordered the Company to pay nearly $2.2 million dollars in restitution, which will…

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FDA/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy

FDA, FTC Disease Claims, Drugs, Enforcement, FDA, FTC, Labeling, Substantiation, Warning Letters

On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler as a cold and flu remedy. The “GermBullet” is sold online as well as in small pharmacies and health food stores. You can read the warning letter here. According to the text of the Warning Letter, the FDA targeted the Company, Flu & Cold Defense, along with its managing member Todd Whidden, for marketing the “Germ Bullet” as an unapproved…

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FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War

FTC Beverages, Dietary Supplements, Enforcement, Food, FTC, Substantiation

On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful LLC (“The Company”) pursuant to a recent ruling by Chief Administrative Law Judge (“ALJ”), D. Michael Chappell. In an Order dated May 17, 2012, Judge Chappell directed the juice giant to refrain from making statements that POM Wonderful 100% Pomegranate Juice and POMx supplements can prevent or treat heart disease, erectile dysfunction and prostate cancer unless the Company has “competent and reliable scientific evidence” to substantiate these claims. Although the FTC is largely heralding the ALJ’s order as a victory,…