Major Changes Coming to Nutrition Facts and Supplement Facts Labels Near You

By Marshall E. Jackson Jr., Kristen R. Klesh, Jonathan Havens & John Moore on May 23, 2016

FDA finalizes rule to revise Nutrition Facts panels for foods and Supplement Facts panels for Dietary Supplements On May 20, 2016, the U.S. Food and Drug Administration (FDA or the Agency) issued a final rule (Rule) that overhauls the design and content of nutrition labeling for foods and dietary supplements (known as the Nutrition Facts label for packaged foods and the Supplement Facts label for dietary supplements). These changes are largely consistent with those proposed…

All About Advertising Law

FTC Creates Compliance Tool for Mobile Health App Developers; Simultaneously Releases Business Guidance

By Jonathan Havens, Marshall E. Jackson Jr., Julia Kernochan Tama & Thora A. Johnson on April 6, 2016

The Federal Trade Commission (FTC or the Commission) announced yesterday that it has created a web-based guidance tool for developers of health-related mobile applications (health apps). FTC did not take this action alone, but rather developed the tool in conjunction with the Department of Health and Human Services’s (HHS) Office of the National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR), and the U.S. Food and Drug Administration (FDA). As some readers…

All About Advertising Law

CA Agency Proposes Emergency Bisphenol A (BPA) Exposure Warning Regulation, Maximum Allowable Dose Level for BPA

By Marshall E. Jackson Jr. & Jonathan Havens on March 21, 2016

CA Office of Environmental Health Hazard Assessment proposes both an emergency regulation to allow temporary use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages, and a Proposition 65 Maximum Allowable Dose Level for BPA On March 17, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a proposal to promulgate an emergency regulation to allow temporary use of a standard point-of-sale warning message for bisphenol…

All About Advertising Law

Aloe Vera (Non-Decolorized Whole Leaf Extract) and Goldenseal Root Powder Now Included on California’s Proposition 65 List

By Todd A. Harrison, Claudia A. Lewis, Marshall E. Jackson Jr. & Jonathan Havens on December 7, 2015

Countless Cosmetic and Dietary Supplement Products Implicated Effective Friday, December 4, the California Office of Environmental Health Hazard Assessment (OEHHA) listed Aloe vera (non-decolorized whole leaf extract) and goldenseal root powder as carcinogens on its list of Chemicals known to the State of California to Cause Cancer or Reproductive Toxicity (Proposition 65 List), pursuant to the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 65). This action…

All About Advertising Law

First Amendment Protects Certain Truthful, Non-Misleading Statements about Off-Label Drug Uses

By Ralph Tyler & Jonathan Havens on August 7, 2015

The Food and Drug Administration (FDA), along with other federal authorities, has been zealous in prohibiting drug companies from making promotional statements about their drugs with respect to uses (indications) for which FDA has not granted approval. FDA’s long-held view has been that “off-label” promotion is unlawful, even if the statements are truthful and non-misleading. A new court decision casts a dark First Amendment cloud over FDA’s absolutist position. On August 7, 2015, Judge Paul…

Jonathan Havens

Major Changes Coming to Nutrition Facts and Supplement Facts Labels Near You

FTC Creates Compliance Tool for Mobile Health App Developers; Simultaneously Releases Business Guidance

CA Agency Proposes Emergency Bisphenol A (BPA) Exposure Warning Regulation, Maximum Allowable Dose Level for BPA

Aloe Vera (Non-Decolorized Whole Leaf Extract) and Goldenseal Root Powder Now Included on California’s Proposition 65 List

First Amendment Protects Certain Truthful, Non-Misleading Statements about Off-Label Drug Uses

Company

Support

New to the Network