Loren Israelsen, the executive director of the United Natural Products Alliance (UNPA), said the Food and Drug Administration guidance would make it make it more difficult for companies to market liquid products as dietary supplements if the functional claims were not based on ingredients possessing taste, aroma or nutritive value.
“The DS industry has labored very hard for many years to overcome this regulatory construct, which is now being reasserted in this guidance,” Israel said in an email to industry this week.
“My prediction is that FDA will, in the coming year, reassert the taste, aroma, nutritive value test as part of its process to distinguish dietary supplements from conventional foods.”
The FDA, reacting to what it considered an unhealthy rise of such practices, issued the guidance this month. It can be found here.
The 1983 case – Nutrilab v Schweiker - concerned a starch blocker called konjac root fiber or glucomannan.
Representations
Israelsen also took issue with the idea of ‘product representation’, raised in the guidance, which he said was, “extraordinarily vague”.
“Even if your label, labeling and advertising are based on DSHEA/dietary supplement templates (supplement facts panel, Section 6 disclaimer, structure/function claims, etc.), FDA suggests that they retain the final decision to decide what is a food or dietary supplement,” he wrote.
Packaging, volume, brand name, bottle or can shape or size, use of words such as beverage, drink, water, juice or similar terms, could all individually or in collectively, influence final categorization of a product.
“This concept would clearly also extend to other kinds of delivery systems such as bars, mini snacks, shakes, yogurt cups, etc. So, we are once again back to a major discussion point of ‘delivery system determines regulatory status’."
The vagaries of GRAS (generally recognized as safe) status was also highlighted, especially intended use, which if not defined could cause classification problems.
“GRAS affirmation is based on intended use. What FDA is driving at is that you may be GRAS affirmed for something, but if ingredient X is used in higher levels or under new conditions of use, say good-bye to your GRAS affirmation.”