Although an Interim Final Rule (IFR) published in 2000 only allowed supplements containing esterified phytosterols to make cardiovascular health claims, the FDA issued an enforcement discretion letter in 2003 that authorized such claims on supplements containing non-esterified or ‘free’ phytosterols, provided they met the conditions of use.
Since then, noted CRN vice president, scientific and regulatory affairs, Duffy MacKay, scores of supplements with free phytosterols have hit the market: “In fact, the majority of phytosterol supplements contain phytosterols in free form."
‘Arbitrary and capricious decision-making’
Thus, the FDA’s December 2010 proposal to terminate that enforcement discretion and rewrite the rules to broaden the use of such claims on foods - but prevent their use on supplements containing free phytosterols – came as a huge shock to the trade, said MacKay.
“The announcement failed to acknowledge, much less justify, the disparate standards applied to dietary supplements and conventional foods…The termination of enforcement discretion is arbitrary and capricious agency action that cannot stand," added MacKay in a 14-page letter to the FDA submitted after the comment period on the controversial proposal was reopened.
It also amounted to a failure of due process given that the FDA’s 2003 letter “unequivocally stated that enforcement discretion would remain in effect until issuance of a final rule”, he pointed out.
“The summary termination of enforcement discretion in accordance with the February 2003 letters has created an untenable situation for the dietary supplement industry.”
Time is running out
Given that the official date for the enforcement discretion to end is February 2012, supplement makers now have less than three months to change their labels and formulations to comply with the Dec 2010 proposal, said MacKay.
“Reformulation and relabeling are extremely complex undertakings, entailing multiple steps, and typically requiring at least 18 months.”
Moving the goalposts - again
To add insult to injury, they also face the prospect that the FDA could change the goalposts again when it publishes its final rule on phytosterols and health claims at some unspecified point in the future, he added.
“The final rule may well differ from the December 2010 proposal... Thus, companies that make changes to align their products with the criteria in the [Dec 10] proposed rule may have to go through this arduous process a second time to conform to requirements of the final rule.”
He added: “The December 2010 summary termination of the February 2003 enforcement discretion letters represents the kind of arbitrary and capricious decision-making that has long been condemned.”
The CRN is calling for the FDA to continue to exercise enforcement discretion in accordance with the 2003 letters until the effective date of the final rule, “or, at a minimum, until the next uniform compliance date for food of January 1, 2014”, said MacKay.
The science
Several firms have challenged the FDA’s argument that evidence supporting the cholesterol-lowering abilities of supplements containing free phytosterols is ‘limited and inconsistent’, MacKay told NutraIngredients-USA last month.
“The issue is about dispersibility. Several companies have presented data that proves their supplements with free phytosterols are effective at lowering cholesterol, and that what matters is getting the formulation right.”
For example, some free phytosterol powdered supplements designed to be added to foods or drinks before consumption overcame dissolution and distribution limitations, he said, while tablet and capsule formulations of free phytosterols that disintegrated efficiently had also been shown to be effective at lowering serum cholesterol.
If the FDA ultimately proved inflexible on this issue, firms currently making supplements with free phytosterols would either have to remove health claims from their packs or reformulate their products using esterified phytosterols, which meant more expense and more capsules, he said.
Botanical Laboratories: FDA move will cause us irreparable injury
In a petition submitted to the FDA earlier this year, Washington-based supplement maker Botanical Laboratories claimed the FDA had scuppered its launch plans for a new supplement.
The firm, which makes supplements under the Wellesse brand, said: “Prior to the amendment … Botanical Laboratories was poised to introduce a heart health liquid dietary supplement featuring sufficient free phytosterols per 2-tablespoon serving to meet the requirements of the 2003 enforcement discretion letters.”
If the FDA rejected its petition, it would suffer “irreparable injury”, it claimed.
”Botanical Laboratories’ product development work would need to be redone to determine whether esterified phytosterols can be formulated into a shelf stable palatable liquid dietary supplement.
“Esterified phytosterols are more expensive than the free form… a finished liquid product containing that form may be cost prohibitive and not commercially viable. Thus, failure to grant a stay will likely doom this proposed product.”