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Pareto Policy Solutions, LLC is a policy analysis and advocacy firm committed to advancing sustainability through “smart” regulation: regulation that rewards, and does not penalize, superior performance.  Often, such actions leverage advances in science and technology and make the regulatory program itself more effective as well as more efficient.

FDA Flexes Its Muscles


In the last six weeks, FDA has indicated a willingness to regulate on three matters impacting consumers.  These three regulatory initiatives are garnering lots of attention.

First, FDA is planning to remove trans-fats (i.e., partially hydrogenated oils) from the list of food ingredients generally recognized as safe.  It has made a preliminary determination, open to a 60-day public comment period, in which it seeks information about the time food manufacturers need to transition to alternative ingredients.  If FDA finalizes its determination, trans-fats would be food additives and could not be used in food without FDA permission.  Because consumption of trans-fats raises bad cholesterol, elimination of trans-fats is expected to provide health benefits.

Second, FDA has issued guidance asking the pharmaceutical industry to stop selling antibiotics for animal feed.  Specifically, FDA is asking pharmaceutical companies to voluntarily revise the FDA-approved use conditions to remove production purposes.  FDA is also changing the over-the-counter status of these antibiotics.  Over time, the use of these antibiotics in animals will require veterinary oversight. The goal is to reduce the growing problem of antibiotic resistance to those drugs used to treat human infections.  FDA says it is taking a voluntary approach because that is the fastest way to achieve its goal.

Third, FDA is asking makers of over-the-counter antiseptic washes (i.e., antimicrobial soaps) to prove safety and efficacy. Specifically, FDA is proposing to amend its 1994 proposed rule by establishing conditions under which such products are generally recognized as safe and effective.  Makers of these substances will have to provide additional data to FDA.  Specifically, FDA is seeking data demonstrating a reduction in the risk of infections from use of antiseptic washes compared to the use of nonbacterial soap and water.  FDA is also requiring a standard battery of tests used to determine safety.

Each of these issues is high-profile; FDA is likely to receive a significant amount of public comment.

To me, what is most interesting is the expected net benefit of each initiative. 

The benefits of eliminating trans-fats are thought to be significant.  The current trend in US consumption is downward; removing trans-fats entirely from the food supply will accelerate this trend and have positive health benefits.  FDA says its action will prevent, annually, 20,000 heart attacks and 7,000 deaths from heart attacks.

On the antibiotics issue, I have questions relating to the degree to which the voluntary initiative will be embraced, the extent to which the resulting lower antibiotic use in animals will positively impact the degree of antibiotic resistance in the human population, and the cost of compliance.

With respect to antiseptic washes, it will be interesting to see how the Agency estimates the expected health benefits, if any, of its proposed rule. (In its proposed rule, FDA says it cannot estimate the health benefits of a reduction in antiseptic active ingredients absent data on dermal exposure.  This is a rather glaring omission.)

Each initiative should be analyzed with respect to both its costs and benefits.  Absent such an analysis, it is difficult to know a priori whether FDA should move forward or revise its plans.

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