Overview
From 2010 to 2013, The Pew Charitable Trusts conducted a comprehensive assessment of the federal food additives regulatory program. Relying on a transparent process that engaged stakeholders, Pew examined food additive issues in partnership with the food industry, the public interest community, and the federal government, including the U.S. Food and Drug Administration, or FDA. We held five expert workshops and published six reports in peer-reviewed journals. This report summarizes our findings and provides recommendations to address the problems that we identified.
With more than 10,000 additives allowed in food, Pew’s research found that the FDA regulatory system is plagued with systemic problems, which prevent the agency from ensuring that their use is safe. The cause of this breakdown in our food safety regulatory process is an outdated law with two significant problems:
First, the law contains an exemption intended for common food ingredients; manufacturers have used this exception to go to market without agency review on the grounds that the additive used is “generally recognized as safe,” or GRAS, in regulatory parlance. FDA has interpreted the law as imposing no obligation on firms to tell the agency of any GRAS decisions. As a result, companies have determined that an estimated 1,000 chemicals are generally recognized as safe and have used them without notifying the agency. The firms usually use their own employees, consultants, or experts whom they select and pay to make the safety decision with no disclosure or apparent efforts to minimize the inherent conflicts of interest.
Second, the law does not give FDA the authority it needs to efficiently obtain the information necessary to identify chemicals of concern that are already on the market; set priorities to reassess these chemicals; and then complete a review of their safety. Moreover, the agency has not been given the resources it needs to effectively implement the original 1958 law. As a result, FDA has not reevaluated the safety of many chemicals originally approved decades ago, generally rechecking safety only when requested by a company to do so, or when presented with allegations of serious adverse health effects.
What FDA says today about the safety of additives
“It’s perhaps a time to look at what the legal framework looks like and what opportunities there are now to ask and answer questions in new ways because of advances in science and technology.”
— FDA Commissioner Margaret Hamburg, (Reuters, May 2013)
“We’re not driven by a sense that there is a pressing public health emergency. But there are decisions being made based on data that we don’t have access to, and that creates a question about the basis on which those decisions are made.”
— FDA Deputy Commissioner for Foods Michael Taylor, (Associated Press, March 2013)
“FDA plans to issue guidance to industry on meeting the GRAS criteria established under the Act.”
— FDA spokeswoman Theresa Eisenman, (USA Today, August 2013)
To remedy these problems, Pew’s report recommends that Congress update the Food Additives Amendment of 1958 to ensure that FDA:
- Approves the first use of all new chemicals added to food.
- Reviews new uses or changes to existing uses of previously approved additives.
- Streamlines its decision-making process so it is timely and efficient.
- Upgrades its science to determine safety.
- Uses the scientific tools and data it needs to set priorities to reassess the safety of chemicals already allowed in food and to take action where necessary.
– See more at: http://www.pewhealth.org/reports-analysis/reports/fixing-the-oversight-of-chemicals-added-to-our-food-85899518122#sthash.cQHyqL0p.dpuf
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