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Radiopharmacies Celebrate the New Year with Long-Awaited FDA Guidance
  • Reed Smith LLP
  • USA
  • December 31 2016

On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft

Special focus: avoiding potential pitfalls associated with functional food claims
  • Manatt Phelps & Phillips LLP
  • USA
  • October 14 2011

Functional foods or foods often fortified with nutrients that offer functional benefits are among the fastest-growing categories of foods, but as their popularity increases, so too does scrutiny over whether these foods truly provide all of their claimed health benefits.

Distributor enters guilty plea for unapproved development and sale of stem cells
  • Shook Hardy & Bacon LLP
  • USA
  • September 1 2011

An Arizona woman who formerly owned a company that sold stem cells to clinics to treat patients with incurable autoimmune diseases, such as amyotrophic lateral sclerosis and multiple sclerosis, has entered a guilty plea to charges that she did so without meeting Food and Drug Administration (FDA) requirements.

New regulations expand FDA's power to seize food; require additional disclosures from food importers
  • Jones Day
  • USA
  • July 1 2011

On January 4, 2011, President Obama signed into law the Food Safety Modernization Act ("FSMA").

FDA: hand sanitizer, antiseptic claims false
  • Manatt Phelps & Phillips LLP
  • USA
  • May 12 2011

The Food and Drug Administration sent letters to four companies warning them that they were violating the Food, Drug, and Cosmetic Act by claiming their hand sanitizers and antiseptic products are effective in preventing infections.

2010 Dietary Guidelines for Americans: key issues for companies that make or market food, beverages, or dietary supplements for the U.S. market
  • Kelley Drye & Warren LLP
  • USA
  • February 3 2011

On January 31, 2011, the U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) issued the Dietary Guidelines for Americans, 2010 (2010 Dietary Guidelines).

Health Canada adopts final guidance document for Schedule A and Section 3 of the Food and Drugs Act
  • Gowling WLG
  • Canada
  • January 14 2011

Health Canada has finalized its revised draft Guidance Document "Schedule A and Section 3 to the Food and Drugs Act" effective October 19, 2010.

FDA-related issues in the OIG 2011 Work Plan
  • Alston & Bird LLP
  • USA
  • October 28 2010

The Office of Inspector General (OIG) recently released its Fiscal Year (FY) 2011 Work Plan.

FDA warns electronic cigarette makers
  • Manatt Phelps & Phillips LLP
  • USA
  • September 28 2010

The Food and Drug Administration sent warning letters on September 8, 2010, to five makers of electronic cigarettes, cautioning them that marketing claims suggesting the devices help people quit smoking are illegal.

GAO submits Congressional testimony entitled "herbal dietary supplements: examples of deceptive or questionable marketing practices and potentially dangerous advice"
  • Kelley Drye & Warren LLP
  • USA
  • May 27 2010

On May 26, 2010, the GAO submitted testimony to the U.S. Senate Special Committee on Aging, entitled “Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice.”