Phytosterols Puzzle

March 30, 2011

If you manufacture a product with phytosterols, beware. A series of recent regulatory developments is giving the health claim a face lift.

If you manufacture a product with phytosterols, beware. Plant sterols and plant stanols (collectively known as phytosterols) have one of FDA’s few approved health claims: “Phytosterols may reduce the risk for coronary heart disease.” However, a series of recent regulatory developments is giving the health claim a face lift. Are you ready to update your formulations, product labels, and more?

Foods containing phytosterols were first allowed a heart-health claim in 2000, but the fact of the matter is that FDA never issued a final rule because of “…complexities of the issues involved and the lack of agency resources….” By 2003, FDA offered enforcement discretion for phytosterol products not fully covered in the 2000 ruling-namely, allowing products with mixtures of plant sterols and stanols to bear the heath claim, as long as certain conditions were met.

In December, after years of lingering enforcement discretion and mulling over new science, FDA suddenly published a “proposed rule” reflecting a variety of suggested changes. Most alarmingly, it proposed a compliance deadline of February 21, 2011. At the time of the notice, this deadline was a mere 75 days away.

Specifically, FDA is now proposing:

  • A product must provide 500 mg of phytosterols daily in order to use the FDA-approved health claim. (This is a 100-mg threshold increase from the 400-mg level proposed in the 2000 rule.)

  • Food products containing nonesterified phytosterols are now eligible to use the health claim.

  • Dietary supplements (previously ineligible for a health claim) are also now eligible for the claim, but only if they contain esterified phytosterols.

  • Products must list plant sterols and/or plant stanols more generally as “phytosterols,” to increase consumer recognition of the ingredients.

  • Phytosterols no longer need to be consumed twice daily to merit the claim.

These and other changes will inevitably require some time (and money) to implement, in order to phase out some products, create new formulations, draft new labels, update website claims, etc.

So why did FDA originally offer so little time for so much work? Moreover, the agency jarred industry when, three days before the February 21 deadline, it announced a one-year extension to meet the new claims, ensuring that a final ruling would be published “as expeditiously as possible.” Is it any wonder that companies marketing phytosterol products have been left a bit confused?

Ramona Cappello is CEO of Corazonas Foods Inc. (Los Angeles), a marketer of tortilla chips, potato chips, and oatmeal squares containing nonesterified phytosterols. Nutritional Outlook caught up with her weeks after the proposed ruling was printed.

“If in fact this deadline is observed, how do we change our health claim?” she asked. “Our attorney tells us that the new language is not clear for our products.

There’s a final ruling from 2000, but there is no new final ruling to change that language. It’s confusing right now, and we’re hoping for clarity in a few weeks.”
There’s no telling if the final rule will include further changes. In the meantime, however, some companies are already preparing.

“We’re now offering our phytosterols in the ester form,” says John Alkire, president of AHD International LLC (Atlanta), developer of Leanitin phytosterols. “A lot of our customers are in the process of transitioning to esters, just to be safe. We believe the ester is going to be the primary form going forward. It’s more difficult to work with esters because they are waxier, but we have to be prepared for the future.”