FDA SEC Reporting – Regulatory Reviews for SEC Forms

FDA SEC Reporting Regulatory Reviews in Form 8-K FDA SEC Reporting does not readily come to mind when considering foods, dietary supplements, drugs, cosmetics (so call “cosmeceuticals”), or medical devices. This is because it is not often the case where FDA regulation and law overlaps or impacts the Security and Exchange Commission. One of the…

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Nutrient Content Claims + KIND Warning Letter

KIND Warning Letter FDA Nutrient Content Claims

What is a Nutrient Content Claim? The US Food and Drug Administration appears to have riled fans of the KIND snack bar with a recent Warning Letter. The Warning Letter cites KIND for failing to following the heavily regulated category of claims known as “nutrient content claims.” This has left some wondering whether the FDA…

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FDA Warning Letters

The Significance of Warning Letters FDA Waring Letters are the most commonly used enforcement tool. Employed across product categories FDA Warning Letters are common food, dietary supplements, cosmetics, drugs, medical devices, biologics (including clinical and pre-clinical research), veterinary medicine (food, supplements, drugs), and tobacco products (cigarettes and e-cigarettes). The FDA views Warning Letters as serving…

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FDA Regulatory Status Call

Managing Engagement with the US FDA to Avoid Penalties One of the most challenging aspects of working with the FDA is engaging directly with the FDA. In particular when the topic of discussion is potential enforcement action, such as a Warning Letter or Recall. This is often the case for a FDA Regulatory Status Call.…

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GNC to Strengthen Supplement Quality Controls – Implications for Suppliers

The New York Times reported that the GNC will institute “sweeping new testing procedures” on its herbal supplements following an investigation and accusations from the New York State attorney general’s office. New testing procedures will be rolled-out over the next 18-months. The new program will have lasting implications for the numerous suppliers of GNC private…

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FDA Food Contact Formulation Notification Guidance

FDA Food Contact Formulation Notification Guidance FCF Overview FDA food contact formulation (FCF) notification guidance plays an important role in determining regulatory status of components of a Food Contact Material. Many industry professionals may be surprised to learn the FDA regulates food packaging. Food packaging is considered an indirect food additive. Determining the regulatory status…

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Cuban Cigars and the FDA

FDA Cuban Cigars Import Registration Rules Requirements Center for Tobacco

With the announcement today by US President Barack Obama that the United States will begin to normalize relations with Cuba a number of questions come-up. In terms of FDA regulations, perhaps, the most interesting question will be how the FDA regulates Cuban cigars. The FDA Center for Tobacco Products (CTP) requires registration for manufacturers of…

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Review: FY 2014 Inspectional Observation Summaries

FDA FY 2014 Inspectional Observations Form 483 Comparison Top Ten Summaries

At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the FDA begins October 1 and concludes on September 30. The fiscal year summary provides an excellent opportunity to review the enforcement activities and interests of the FDA. In comparing the…

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