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Sens. Hatch and Harkin Send Letter to FDA in Anticipation of NDI Guidance
Senators Hatch and Harkin, the principle architects of the Dietary Supplements Health and Education Act (DSHEA) (amending the Federal Food Drug and Cosmetic Act (FDCA)), submitted a letter yesterday to FDA Commissioner…
Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products
This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to…
New Food Safety Law Sets the Stage for Industry Participation in Numerous Rulemakings
The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, requires the Food and Drug Administration (FDA) to undertake sweeping regulatory action to strengthen the safety of the nation’s food…
Dietary Guidelines for Americans, 2010
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 . A copy of the executive summary is available here…
New Trends in Health-Related Advertising Claims
Companies marketing functional foods or dietary supplements should be aware of the Federal Trade Commission’s new regime for using health-related advertising claims and the Food and Drug Administration’s heightened…