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FDA Issues First E-Cigarette Warning Letters

While FDA’s tobacco products “deeming rule” is pending, the Agency issues Warning Letters to e-cigarette and e-liquid companies for the first time....more

While FDA’s Proposed e-Cigarette Rule is Pending, FTC Mulls Enforcement Action

Ahead of finalizing FDA’s tobacco products “deeming” rule, the FTC considers taking enforcement action against e-cigarette firms for violative advertising, marketing, and sales practices....more

3/24/2015  /  E-Cigarettes , FDA , FTC , Popular

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

FDA Rule Prohibits Certain Nutrient Content Claims for Omega-3 Fatty Acids

The final rule prohibits label claims of food products, including dietary supplements, that are “high in,” “rich in,” or an “excellent source of” DHA or EPA and allows some nutrient content claims for ALA. On April 28,...more

FDA Proposes Tobacco Products Rule; E-Cigarettes, Cigars To Be Regulated

The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register...more

4/28/2014  /  E-Cigarettes , FDA

FDA Proposes Food Defense Rule to Protect Against Intentional Adulteration

New mandate would apply to major U.S. and international food processors and handlers. On December 24, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule, Focused Mitigation Strategies to...more

1/6/2014  /  FDA , Food Contamination , Food Safety

FDA Releases Good Manufacturing Practices for Animal Food

Proposed requirements dictate a substantial upgrade of the current regulatory standard of care. On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more

11/1/2013  /  FDA , Food Safety , FSMA , Manufacturers

FDA Issues Long-Awaited Final Guidance on Mobile Medical Applications

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

Final Sunshine Act Arrives: Now the Hard Part

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

FDA Releases Major New Food Safety Proposals

Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....more

1/10/2013  /  FDA , Food Manufacturers , Food Safety , FSMA
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