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District Court sides with Industry on Dietary Supplement Substantiation

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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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FDA “Natural” Food Labeling

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On November 12, the U.S. Food & Drug Administration (“FDA”) announced that it is soliciting public comments on how the Agency should define the term “natural” and regulate its use in food labeling. The FDA has engaged the public’s input after receiving two Citizen Petitions requesting the agency take action on establishing a formal definition of the term “natural” for use in food labeling and one requesting asking that the agency prohibits the use of the term “natural” on food labels. The FDA also notes that this recent move is driven by recent private litigation surrounding the term “natural” in…
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Court Issues Injunction after FDA Warning Letter Issues Persist

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On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration ("FDA") regulations and mandated standards (Current Good Manufacturing Practices or “CGMPs”). According to the FDA, the steps taken by the manufacturer in response to an FDA warning letter and FDA inspections did not bring the facility back into compliance with the CGMPs, prompting FDA to move forward with the action for injunction. In the case against the company, the judge signed a consent decree of permanent injunction, which requires…
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FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

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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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Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

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On August 8, 2014, the U.S. Food and Drug Administration ("FDA") obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In addition to purported manufacturing deficiencies, the Company, BioAnue, sold dietary supplements that were marketed as treatments for common diseases, causing the FDA to deem these products to be unapproved new drugs. The FDA’s announcement can be found here. BioAnue received a warning letter from the…
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FDA Warning Issued Regarding Weight Loss Products

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On April 7, 2014, the U.S. Food and Drug Administration ("FDA") released an advisory, warning consumers not to use bee pollen capsule marketed under the name Zi Xiu Tang Bee Pollen. The purpose for the advisory, previously reported here, was to alert the public that the product contained potentially harmful active pharmaceutical ingredients, which had not been listed on the label for the product and was the subject of a FDA warning letter. The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk…
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FDA Publishes Food Allergen Labeling Guidelines

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On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its "Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The draft guidance represents current thinking on the topic as previously discussed through the release of the October 2006 "Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance." The guidance provides the FDA's answers to commonly asked questions concerning the notification process for those seeking exemptions from the labeling of food allergens and updates the responses in the 2006 document. You…
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FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients

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On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company's dietary supplements include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label. After testing a variety of different Zi Xiu Tang Bee Pollen dietary supplements, the FDA has discovered that each product contained at least one of the listed unnamed drug ingredients: Phenolphthalein - A substance that is associated with cancer and is not a current…
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FDA Moves to Update Nutrition Facts Label for Foods

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On February 27, 2014, the U.S. Food and Drug Administration's ("FDA") moved to update nutrition facts labels (“Nutrition Facts Panels”) on packaged foods and dietary supplements. The proposal was prompted by recent scientific findings that suggest there is a direct correlation between excessive food intake and recurring diseases, like heart disease and obesity. In addition, the proposed labeling will replace outdated serving sizes to help deliver a better perception of actual food intake by consumers today. The proposed Nutrition Facts Panels will provide a new, unique approach that highlights certain parts of the label like serving sizes, ingredients and caloric…
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FDA Issues Statement on IOM Report on Safety of Caffeine in Foods

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On January 21, 2014, the U.S. Food & Drug Administration (“FDA”) issued a Statement on the Institute of Medicine’s Report (“IOM Report”) on Caffeine in Foods. Released on January 17, 2014, the IOM Report is a culmination of the recent public workshop, which took place in August 2013 and was focused on the investigation of the continued safety of caffeine in foods and dietary supplements. The IOM Report highlights the issues surrounding the safety of caffeine in foods and concludes that continued research is necessary to determine whether caffeinated foods and dietary supplements are safe, particularly for children and adolescents.…
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