Jonathan Havens

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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…
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…
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…
  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…
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…