A move by FDA to change the way it regulates supplements containing phytosterols that are marketed as reducing the risk of coronary heart disease via cholesterol reduction would cause serious economic damage to supplement companies, said Duffy MacKay, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, in a recent public comment letter to FDA.
But FDA is unlikely to modify its position on the science relating to the issue unless additional data (read: new studies) can be brought to bear, according to Brian Waldman, an attorney with Washington, D.C.-based law firm Arent Fox who represents dietary supplement and functional food companies. "FDA spends a lot of time on things like this and they don’t like to be reversed," he said.
At issue is which supplements may bear the approved health claim linking plant sterols or stanols with a reduced risk of coronary heart disease. FDA’s initial ruling on the subject in 2000 covered only the esterified forms of phytosterols in restricted food categories.
Many comments from industry said that the health claim should apply also to free forms of phytosterols and phytostanols, claiming that the free form of these molecules is what binds to the intestinal lining and inhibits cholesterol uptake from the diet, thus conferring the health benefit. FDA in effect agreed to suspend final judgment on the free vs. esterified issue and modified its stance in 2003 via "enforcement discretion" letters. These letters are now due to expire on Feb. 21, 2012. On that date the free sterol/stanol products can no longer use the health claim.
What's at stake for supplement marketers
The core of the issue is what can be said on labels concerning the product’s health benefits. The approved health claim wording contains a section on dosage levels and concludes with the powerful phrase (which marketers often put in bold type): "may reduce the risk of heart disease."
After the discretion letters expire, companies who might choose to continue to market products containing the free forms would have to use the approved structure/function claim connected with cholesterol reduction, which is: "helps maintain cholesterol levels that are already in the healthy range." Chances are that products bearing such labeling would no longer be commercially viable.
Efficacy depends on formulation, FDA says
In making its determination, FDA concluded that data showed that the efficacy of the products containing free phytosterols was highly specific to the formulation, meaning some formulas showed a benefit, others didn’t, making it inappropriate to approve a blanket health claim for all. In his letter, MacKay took issue with this finding, saying this determination was based on the results of only three studies.
MacKay also cited the costs this "abrupt change" could put on supplement companies, which he said had been acting in good faith based on the enforcement discretion.
Companies might be faced with a large number of returns from retailers when the next "planogram" changes take place (i.e. the next scheduled change of what’s featured on store shelves—a change that most retailers undertake twice a year).
- Companies cannot reformulate products in time, a process that often takes up to 18 months. And, MacKay noted, it’s often not just a matter of dropping a new product in place of the old, because new shelf tags are needed, new product codes, new prices, etc.
In CRN’s letter, MacKay formally requests an extension for the expiration of the enforcement discretion, asking as "a bare minimum" for an expiration date of Jan. 1, 2014, which is the next uniform compliance date for food labels set in Federal regulations. Such an extension, MacKay said in the letter, would allow companies to reformulate and/or relabel their products and "allow for an orderly transition to dietary supplements labeled and formulated in accordance with the criteria."
On this last subject, FDA might show some leeway, Waldman said. "FDA might alter the time frame and allow more time for companies to sell through their products," he said.