After weeks of behind-the-scenes negotiating, President Obama has named Margaret Hamburg and Joshua Sharfstein as FDA Commissioner and Deputy Commissioner respectively.
What can the dietary supplements and functional food industries expect from this duo?
The clues come from President Obama himself. On March 14, 2009, in a radio speech, he stated: “There are certain things only a government can do, and one of those things is ensuring that the foods we eat and the medicines we take are safe and do not cause us harm.”
He also noted that many of the US food safety laws have “not been updated since they were written in the time of Teddy Roosevelt [a reference to 1906] and that FDA is underfunded and understaffed”. These comments are a direct reference to food safety failures of melamine, spinach, ground beef, and peanut butter as well as the Rx drug heparin and other important prescription drugs withdrawn from the market due to safety reasons.
The President has given the FDA money, manpower and a mandate to fix the food and drug safety systems.
Clampdown
But how exactly will this new FDA team affect the supplements and functional food sectors? The expected measures will not be specific attacks on these categories but rather the effect of a rising tide on all FDA-regulated industries. Here are specifics:
· Expect a significant increase in dietary supplement GMP inspections in Q3 and Q4 of 2009 continuing through 2010. These will be tough, no-nonsense inspections.
· There will be a sharp increase in imported food inspections along with more testing, delays and rejections at the point of import. Manage your supply chain and inventory accordingly.
· There will likely be confrontations over the use of irradiation, which the FDA has specifically noted as illegal under the new dietary supplements GMP regulation.
· The FDA is implementing fast and efficient search engines to survey key words such as ‘shark cartilage + cancer’. Expect an increase in warning letters over disease-related claims.
· I predict the FDA will show a new interest in nanotechnology. Specifically, nanotech food and supplement ingredients will be regarded as either new dietary ingredients or unapproved food additives. Either way, nanotech is on the radar.
· The FDA will likely publish a new dietary ingredient guidance document this year, which has been languishing at the agency for at least 12 months.
· Congress is preparing to debate and pass major food safety legislation that will likely include requirements for either third party certification or external audit systems to manage supply chains extending all over the world.
In short, the FDA, with a strong mandate, new funding and more staff, will soon reemerge as a regulatory power, not just in the US but on the world scene.
Backgrounder: Hamburg and Sharfstein
But who are Margaret Hamburg and Joshua Sharfstein, and why have they been chosen to head the FDA? Their backgrounds seem to have many interesting parallels.
Both are medical doctors. Both graduated from Harvard Medical School. Their parents were all physicians and prominent ones at that. Dr Sharfstein’s father was past president of the American Psychiatric Association. Dr Hamburg’s mother was the first African American Woman to attend Vassar College (a very elite Ivy League Women’s College).
Dr Hamburg’s expertise ranges from neuro-pharmacology, AIDS research and bioterror defense program. Dr Sharfstein is a pediatrician with interests in AIDS, tobacco regulation and, more recently, safety issues with children’s cough and cold medicine.
Both have run large public health programs – Hamburg as New York City Health Commissioner, and Sharfstein as Baltimore’s Health Commissioner. This was seen as an essential requirement to manage an agency with over 11,000 employees.
Finally, and importantly, both have Capitol Hill experience and champions. Hamburg is well liked by Senator Kennedy’s office, and Sharfstein is a former senior staffer to House Energy and Commerce Chairman Henry Waxman, who many regard as the key player on FDA oversight in the Congress.
It is widely thought that Sharfstein’s close ties to the Waxman office would have set up a confirmation battle with Senate conservatives concerned about the direct pipeline to the Waxman office, and the pharmaceutical industry saw Sharfstein as an unsettling choice, given his historic criticism about unseemly ties between the drug industry and funding of ‘medical education programs’ of dubious nature.
Dr Hamburg, the lesser known, was considered both well qualified and politically unburdened – both essential characteristics. Perhaps most importantly, the Deputy Commissioner position does not require Senate confirmation, thus avoiding a potential showdown in the Congress with Dr Sharfstein.
The new Commissioner and Deputy Commissioner will be given the green light to re-establish FDA as a global regulatory power.
Neither one has any history relating to supplements and functional foods that provides specific guidance on how they may view the Dietary Supplements and Health Education Act (DSHEA) or related matters. But, as noted, a re-energized FDA will surely affect the regulatory and enforcement environment that will only become tougher and more focused under this new administration.
Loren Israelsen is executive director of the dietary supplements trade group United Natural Products Alliance (UNPA), which was instrumental in the development and passage of DSHEA in 1994.
Part I in this series can be accessed here and looks at other key players in the White House and their possible impact on the functional food and supplements industries.