Industry partnerships key to FDA modernization, Ostroff says

Ostroff spoke at the annual meeting and workshop held by the Council for Responsible Nutrition, which took place last week near Tucson, AZ.  Ostroff, who is deputy commissioner for Foods and Veterinary Medicine, said FDA is executing on a 10-year strategic plan to modernize its operations that has been necessitated in part by the phenomenal growth of the dietary supplement market.  So much has changed since the passage of the Dietary Supplements Health and Education Act in 1994, but one thing that hasn’t changed much is FDA itself, Ostroff said.

Changes in market landscape

“​At the time of DSHEA we estimated that there were about 4,000 products on the market and about $4 billion in sales. If you look at the market some 20 years later we estimate there are about 80,000 products in the market and sales of about $40 billion. That is really phenomenal growth over two decades,​”​ Ostroff said.

“​In 1994 the first conference was held to discuss the commercialization of the Internet.  One of the lead speakers was the CEO of Netscape. If you look at the landscape today, you are all part of an incredible globalized market, with very complicated supply chains.  We have social media today and we have web sales.  Synthetic biology is a concept that would have been unheard of in 1994.  You have machine learning that allows you to ​micro target​ your customers, robotics and so forth,​”​ he said.

Strategic plan

In an effort to become more agile in dealing with these changes FDA has embarked on a 10-year strategic plan to modernize the agency which was made public in July.  Ostroff said the priorities that undergird the work are:

• Public health is the first priority.

• Partnerships are the key to success.

• Scientific expertise and research are the foundations of the FVM Program’s work. • Operating openly and transparently is a core principle.

The plan is broken down into buckets of food safety, nutrition, animal health and organizational excellence. Ostroff said the magnitude of the challenge is such that strong partnerships with industry are the only way the agency can become fully abreast of the times.  For example, he said when he came on board with the agency in 2013, rather than the broad brush strategic vision role he was anticipating, he was presented with a crisis that had to do with a single ingredient—aegeline—that few even within the industry had heard of.

Ostroff came to FDA after a career with the Centers for Disease Control, where he dealt with the outbreaks of the Ebola virus, SARS and avian influenza, among others.  He said he had assumed that background would translate easily into his new duties as chief scientist at FDA.

“​I thought I would be dealing primarily with issues relating to food borne illness,​”​ he said. “​Instead, about a week or two after I arrived, I ended up having to deal with ​[the OxyElite Pro] problem.​”​  ​(OxyElite Pro was quickly withdrawn from the market in 2013 after numerous reports in quick succession of liver injury came in from Hawaii, all associated with the product.)

“​We need to keep abreast of what the trends are within the industry.  As regulators we want to encourage and help support the sectors of the industry that are responsibly marketing dietary supplements. We want to work with you to help you accomplish that,​”​ he said.

Facility inspections

One of the first parts of the plan to be put into place is a reorganization of how facility inspectors do their jobs.  Inspectors now have responsibility according to their expertise, rather than primarily being assigned to geographical areas.  This means that inspectors trained in and familiar with dietary supplement facility inspections will mostly do that work, regardless of the geographical area, Ostroff said.  This will help alleviate one of the criticisms voiced by industry, that being that inspectors sometimes have shown little familiarity with the industry, and were assigned primarily because they were the only inspector available in a certain geographical district.

FSMA implementation

Another area in which an industry/government partnership will be critical to success is with the implementation of the Food Safety Modernization Act, Ostroff said. One of the next steps in this process will be the development of a guidance on how to put together a food defense plan, which he emphasized will apply to dietary supplement firms just as much as it will to straight food companies.

FSMA, which is said to be the biggest change in US food law in almost 80 years, was necessary because the food borne illness picture was looking ominous. Despite much effort and many dollars spent, the incidence of major food borne illness such as outbreaks of salmonella or listeria has not improved and in some cases has gotten worse, he said.

“​We needed to modernize the regulatory structure to account for the diversity of food sources coming into the country,​”​ Ostroff said.