Richard L. Frank

Phil Olsson

We are saddened to share the news that Phil Olsson passed away surrounded by his family on Thursday, June 12th.   His life took him from the cranberry bogs of Massachusetts, to Harvard University, to distinguished service in the federal government, and finally into private practice in Washington, DC.  Alongside Richard Frank, he co-founded OFW […]

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Dietary Guidelines – Confused About Caffeine

The news wires have been buzzing lately about the recently released scientific report of the Dietary Guidelines Advisory Committee. One of the hottest topics for discussion is how out of step the report is on a number of issues, including the Committee’s dive into political matters like sustainability, soda taxes, and “added sugar” labeling. These

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John G. Dillard headshot

Political Science or Sound Science – Is the White House Dictating Nutrition Labeling Reform?

The White House’s role with USDA’s regulations for school foods and the WIC feeding program has been widely reported.  Lesser known is the White House involvement in FDA food labeling policy. To commemorate the anniversary of the Let’s Move! campaign, the first lady hosted a week-long series of events in March, one of which included

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FDA was Busy in 2013 and its Sleigh is Packed Heading into the New Year

While often rightly the subject of criticism for delay or inaction on important regulatory matters, FDA in late 2013 has been bustling.  The FDA, during the second Obama term, has been pursuing a very aggressive regulatory agenda.  In addition to the widely discussed FSMA regulations (e.g., FSMA LIVES…..; FDA Tells Food Importers How It Wants Them

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HHS Guidance Expands Scope of Refill Reminders and Reasonable Costs

As we reported recently, the Department of Health and Human Services (HHS) announced its intent to issue guidance regarding prescription “refill reminder” programs that can be conducted without patient authorization by September 23, 2013.  HHS’s Office for Civil Rights (OCR) actually beat that deadline by four days, publishing its Guidance on September 19, 2013. OCR’s

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“Serving Facts” for Alcohol Beverages—FINALLY!

Yesterday, a 9-year effort by consumer and public health groups, and beer, wine and spirits maker Diageo, succeeded when a unit of the Treasury Department issued a ruling permitting voluntary Serving Facts labels for alcohol beverages. The Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) Ruling 2013-2 allows beer, wine and distilled spirits makers

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New HHS Privacy Rule Conflicts With Congressional Support for Refill Reminder Programs

The Obama Administration (HHS’s Office for Civil Rights) promulgated its new HIPAA Privacy Rule ostensibly to strengthen consumers’ medical privacy rights.  The result, however, is likely to harm patients by restricting clinicians’ and pharmacists’ ability to provide them with compliance and persistence messages – so-called “refill reminders” (about currently prescribed drug therapy).  In fact, as

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“Alcohol Facts” Becomes a Reality: FTC Requires Four Loko To Label Its Product

Nutrition Facts, Supplement Facts, Drug Facts…… Alcohol Facts?  For a number of years, alcoholic beverages have been the only category of consumable product that does not bear basic product information in a consumer-friendly form.  Conventional foods have Nutrition Facts; dietary supplements have Supplement Facts; and OTC drugs have Drug Facts.  But, alcoholic beverages have…. mystery.

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HHS’s Updated Medical Privacy Rules Under HIPAA Could Be Susceptible to First Amendment Challenge

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) issued a long-awaited pre-publication copy of revisions to the federal medical privacy requirements commonly referred to as the HIPAA Privacy Rule.  The final rule, issued pursuant to the HITECH Act, will be published in the Federal Register on January 25, 2013. Although

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