CHK Nutrition and the FDA

In 2010, the Food and Drug Administration (FDA) cited CHK Nutrition for promotional claims with which the FDA took exception. The FDA did not call into question the safety or effectiveness of CHK Nutrition products. CHK Nutrition prides itself on its compliance with FDA rules and regulations. Our commitment to quality has always been and continues to be unwavering.  We have respect for the FDA and are in good standing. Occasionally, we receive questions from Healthcare professionals and patients about the FDA matter. What follows is information regarding this matter.

What was the basis of the FDA’s regulatory actions against CHK Nutrition?

In 2010, the FDA conducted a routine inspection. As part of the inspection, the FDA reviewed marketing materials that CHK Nutrition produced. The FDA took the position that some of the marketing materials used language regarding CHK Nutrition’s products that appeared to be drug claims. CHK Nutrition products are not drugs. They are regulated by the FDA as dietary supplements. The FDA asked CHK Nutrition to stop making the claims in question and CHK Nutrition removed them.

Does CHK Nutrition have any current issues with the FDA?

No. CHK Nutrition immediately changed our marketing and removed any claims with which the FDA took issue.  

If there are no current marketing issues, why are there articles online stating that CHK Nutrition had to shut down/stop selling its products?

We are happy to respond to any articles discovered online. The FDA did not require CHK Nutrition to permanently shut down or permanently stop selling products. After being notified by the FDA that they had concerns about our marketing, CHK Nutrition engaged an external expert and immediately addressed the FDA’s concerns. After that, we went through a brief period of 30 days, during which the FDA reviewed all marketing materials to ensure compliance. During the 30-day period, CHK Nutrition was unable to sell products. After the 30 day period, the matter was considered resolved and we were able to sell our products.

It is common knowledge that reporters and bloggers tend to sensationalize stories in order to attract attention. The reality of the situation was not very exciting —we had advertising that raised concerns at the FDA. We addressed the matter to the satisfaction of the FDA. We immediately resumed business once they were satisfied that we were compliant. All new communications published by CHK Nutrition are reviewed by an outside legal counsel with expertise in FDA law.

What is the current state of CHK Nutrition’s marketing and its relationship with the FDA?

Our marketing continues to be reviewed by an attorney that focuses on FDA law. From time-to-time, CHK Nutrition is routinely inspected by the FDA since it provides dietary supplements. No promotional observations have been made during these inspections.

Why did the FDA take action against CHK Nutrition?

In 2011, the FDA brought legal action against CHK Nutrition and NeuroResearch Clinics because the marketing it reviewed went beyond the claims allowed for a nutritional supplement.  There were no issues raised regarding the safety or formulation. CHK Nutrition was cited for making a drug claim.

What is a drug claim?

Claims that a product can treat, prevent, mitigate, cure, or diagnose any disease are reserved for drugs. Drugs are subject to FDA review. They must be proven to be safe and effective for their intended use. Dietary supplement (i.e., nutritional supplement) manufacturers and distributors are barred by law from making claims that a product can be used to treat, cure, mitigate, prevent or diagnose any disease without the required regulatory approvals for the drug.  If a supplement does not have approval and makes drug claims, this would constitute an unproven medical claim.

What Type of Claims Can a Nutritional Supplement Make?

Sellers of nutritional supplements are allowed by law to make structure-function claims. These claims describe the role of a nutrient or dietary ingredient that is intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.”

Additional guidance from the FDA is available at:

https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006881.htm

Thank you for taking the time to learn the facts and be informed! We are proud of our commitment to providers and patients by providing high-quality clinically validated products.

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