Welcome to the first monthly update on FDA's enforcement
over regulated tobacco products. This update will examine trends in
Warning Letters, and cover some unique Warning Letters and
enforcement actions that have occurred in the previous month. As
the first post regarding tobacco products, we begin with an alert
regarding FDA's issuance of civil money penalty complaints. The
update also provides a summary of tobacco related Warning Letters
issued by the FDA to date.1
The most significant enforcement event over the last month is
the issuance of twenty (20) civil money penalty complaints to
retailers by the FDA....
Specific Questions relating to this article should be addressed directly to the author.
Since last November – 365 days from the 2012 election to be exact – at the invitation of various health care providers, I have been going around the country giving a "crystal ball speech" about the future and outcomes of government spending, health reform, and the election.
The FDA recently issued a draft Guidance titled, "Safety of Nanomaterials in Cosmetic Products" which addresses FDA’s current thinking on how to assess the safety of using nanomaterials in cosmetic products.
Divorces affect every aspect of an individual's life - their financial situation, their children, their home, their friendships, everything. Divorces are notoriously stressful events and, while a stressful marriage can absolutely consume a person to their detriment, many people would also agree that their lives are negatively impacted in some way by the process.
The FDA recently issued a draft Guidance titled, "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives."
In compliance with provisions of the Richard B. Russell National School Lunch Act (79 P.L. 396, 60 Stat. 230), the USDA recently published its proposed rule to establish the requirements for operating the Fresh Fruits and Vegetables Program (FFVP).
The United States District Court for the District of New Jersey has signaled that, on a case-by-case basis, component part manufacturers may be protected from tort claims by the combined effect of the economic loss rule and integrated product doctrine under New Jersey law, despite a New Jersey Supreme Court ruling that left product manufacturers vulnerable to increased exposure in litigation over pure economic loss to a product as a whole.
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has begun auditing covered entities for compliance with the Health Insurance Portability and Accountability Act (HIPAA) under the HIPAA Audit Program (Audit Program).
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