If this determination is finalised, PHOs would effectively be banned from use in foods unless they are first approved by FDA as ‘food additives’, which would likely be difficult. This would have a major impact on the food industry. In particular, products such as doughnuts, cookies, margarine, microwave popcorn, frozen pizzas, baked goods, frostings and many other foods would need to be reformulated.
FDA’s concern focuses on trans fats, which are deliberately produced in the manufacturing process for PHOs to help increase the melting point, shelf life and flavour stability of the oil. Although trans fats exist elsewhere in the diet to some extent, PHOs are the major source.
According to FDA, trans fats may have adverse effects on blood cholesterol parameters that affect the risk of coronary heart disease (CHD) and may have other health implications that, as FDA acknowledges, are unconfirmed. This tentative determination that PHOs are not GRAS follows a 2003 rule requiring labelling of trans fat content in nutrition labelling, as well as various state and local initiatives that have restricted the use of PHOs.
FDA has established a 60-day public comment period from publication of the notice. Given the complexity and economic significance of the tentative finding, it is likely that this period could be extended if requested by stakeholders noting a need for more time to prepare fulsome comments. Besides requesting comments on whether FDA should finalise its tentative determination, the Agency also requests comments on:
John Moore is an Of Counsel in Venable LLP’s Washington office. Dr Moore, who holds a PhD in chemistry, previously worked for food manufacturers overseeing production. This is a personal blog and views expressed are his own.
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