In comments submitted to the docket on the FDA’s proposal to revoke the GRAS status of PHOs, Nestlé, General Mills, ConAgra Foods and other leading food companies say that instead of a flat-out ban on PHOs, the FDA could:
1 - Establish a threshold limit of less than 0.2g of industrially-produced trans-fat per serving.
2 - Change the ‘rounding rule’ for declaring '0g trans-fat' on the Nutrition Facts Panel from less than 0.5g trans fat/serving to less than 0.2g/serving.
This way, notes General Mills (click here), trans-fat levels would be forced down in foods where there are feasible alternatives to PHOs, but manufacturers would still be able to use PHOs in ingredients that contribute negligible amounts of trans-fat to the diet such as color and flavor carriers, spices and processing aids.
Nestlé (click here) also urges the agency to permit minor uses of PHOs in things such as processing aids.
The firm, which has committed to “removing all PHOs as functional ingredients by the end of 2016", says the FDA should however “establish a reasonable specification or de minimis level for trans fat in PHOs in the food supply to account for minor uses of PHOs that have no technical or functional effect in the finished food."
It adds: “These include minor quantities of PHOs created by the action of heat in conventional frying and oil deodorizing processing and uses such as carriers and coatings in flavors, or release agents on processing equipment– i.e., uses that readily qualify as ‘processing aids’ in finished foods and contribute only nominal levels of PHOs (and trans fat) to the these foods.”
Formulation nightmares… without any public health benefit?
The Grocery Manufacturers Association (GMA) also lists several examples of where PHOs are critical to recipes, but contribute only trace amounts of trans-fat to finished foods, and says changing labeling rules is a more practical way to address concerns about trans fat than simply banning PHOs.
For example, PHOs are added to many chewing gum formulations as softeners or texturizers, but gum is not swallowed, and only microscopic amounts of fat are ‘chewed out’ and ingested, it notes.
Meanwhile, the use of PHO-derived emulsifiers, particularly mono- and di-glycerides, is “ubiquitous” (click here) in food applications from cakes to ice cream, toppings, margarine and coffee whiteners, says the GMA.
Banning the PHOs used to make them would create formulation nightmares without delivering “any public health benefit”.
NCA: Trade disruptions
There are also other unintended consequences of a blanket ban on PHOs, claims the National Confectioners Association, (click here) which predicts “trade disruptions” if the FDA follows through with its plan, given that no other countries have banned PHOs altogether.
“Given the widespread use of PHOs in minor food ingredients such as flavorings, colorings, and emulsifiers, it is likely that foods containing small amounts of PHOs would be offered for import into the US,” warns the NCA.
“If PHOs are not GRAS, such foods would be adulterated and refused entry. It is also quite likely that some of these foods would enter U.S. commerce and then have to be recalled.”
The Snack Food Association, meanwhile, stresses that not all PHOs are the same: “New modified hydrogenation techniques can produce PHOs with very low TFA levels and an improved balance of other fatty acids.
“These modified PHOs can be a part of the solution to the problem of reducing TFAs in the food supply, provided FDA does not prohibit their use.”
GMA: Where’s the evidence that trans-fats at current low levels present a health risk?
However, the central argument made by the GMA and its members is that the FDA has failed to prove that the low levels of trans-fatty acids (TFAs) now consumed by Americans present a safety concern.
Says the GMA: “The estimated mean intake of TFA from all sources is now consistent with the target intake of 1% advocated by health organizations, and PHOs currently account for less than 50% of that intake.”
And at levels of intake at or below 2% of energy, the FDA has not presented compelling evidence that TFAs increase the risk of coronary heart disease or increase LDL cholesterol to a clinically significant degree, it says.
Click HERE to read all the comments in the docket.