GRAS approvals highlight Section 912 “nightmare”

By Shane Starling

- Last updated on GMT

GRAS approvals highlight Section 912 “nightmare”

Related tags Dietary supplements Food and drug administration

Industry continues to urge the Food and Drug Administration to close the Section 912 loophole in the Federal Food, Drug, and Cosmetic Act (FDCA) that could allow nutrients such as omega-3s, L-arginine and baobab to be reclassified as drugs.

Section 912 of the Amendments Act enacts FDCA section 301(ll) to prohibit the shipment in interstate commerce of foods to which certain articles have been added, including those that have been the subject of “significant clinical research”​.

Given that almost all ingredients that have won GRAS (generally recognized as safe) approval such as omega-3 have been subjected to “significant clinical research”​ at one point or another, if the letter of the law is applied, such substances can be deemed drugs and therefore banned from use in dietary supplements and the food supply.

The situation is not new as in late 2008 the FDA received more than 80 concerned industry comments on the matter, after the Amendment was enacted in September that year and which covered here.

Many of these comments called on the FDA to define how “significant clinical research”​ relates to substances for use in dietary supplements as opposed to pharmaceuticals.

Despite murmurings from the FDA that the agency is on the case, the issue remains unresolved almost two years after the 912 comment period closed, and there is growing concern an interested party may exploit the loophole sooner rather than later.

GRAS disclaimers

In its GRAS notices the FDA states: “…FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing [product x]. Accordingly, this response should not be construed to be a statement that foods that contain [ingredient x], if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).”

New York-based food and drug attorney Marc Ullman, from Ullman, Shapiro & Ullman, said while the loophole is yet to be tested, the fact the FDA writes disclaimers into GRAS approvals, highlights its own sensitivity to the issue.

“Maybe there are some that are hoping this problem will go away but as it stands a literal translation of this law would take omega-3 out of the food supply,” ​he said. “It is a potential nightmare situation.”

Dan Fabricant PhD, the vice president of scientific and global government affairs at the Natural Products Association agreed that the definition was problematic, and noted that even nutrients only ever intended for dietary supplements often underwent pharma-style trials.

“Someone has to make a decision at some point,” ​Fabricant said.

The FDA says it is looking into the predicament but also highlights the fact citizen’s petitions have the potential to ensure nutrients are not affected by 912/301.

The first petition of this kind was lodged in mid-2009 by Canadian firm, Ovos Natural Health, seeking to alter the status of its amino acid (homotaurine) to a dietary supplement, after it decided the ingredient was ill-suited to life as a drug.

Developing a plan

In a January 25 letter written by FDA​assistant commissioner​for legislation, Jeanne Ireland, to Congressman Dan Burton, the FDA commissioner acknowledged clarification could be beneficial.

“FDA agrees that it would be helpful to clarify the Agency's interpretation of section 301(11) on a number of points, including but not limited to, its implications for dietary supplements,”​ she wrote. The Agency is currently developing a plan to implement section 301(11).”

But in regard to Section 201(ff), which provides the Dietary Supplements and Health Education Act (DSHEA) definition of dietary supplements in the FDCA, Ireland said no further refining was necessary.

“FDA believes that the intent of section 20l(ff), regarding the process for permitting the marketing of a product as a dietary supplement is clear."

Section 201 states dietary supplements cannot contain substances:

• approved as a new drug or licensed as a biologic

• authorized for investigation as a new drug or biologic for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public

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