Showing posts with label statement. Show all posts
Showing posts with label statement. Show all posts

Monday, February 11, 2019

FDA Signals Strengthening Regulation of Dietary Supplements - FDA.gov


Read the full press announcement:  Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Snippets from the FDA Commissioner's statement:
". . . we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer."


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Monday, June 11, 2012

FDA 483s Can Form Basis of Class Action Lawsuit

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the U.S. Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs.

Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report. This is an important event, and here's why . . .

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:

"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."

'via Blog this'

What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.

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