FDA Posts Qualified Health Claim Petition Regarding MCTs Caprylic and Capric Acid for Use in the Management of Migraine Headaches
Friday, May 1, 2020

On March 13, 2020, Ultimate Brain Nutrients, LLC (“UBN”) submitted a Petition (which FDA filed and posted for comprehensive review on April 30, 2020), seeking FDA’s authorization of a qualified health claim for Caprylic and Capric Acid in connection with their use in the management of migraine headaches.

The claims pursued by UBN’s Petition, if approved, would apply only to products containing a minimum of 5 grams of Caprylic Acid at the “Effective Level” of 80% concentration. The active ingredient is identified as Caprylic Acid (with Capric Acid present at a “less ketogenic” level), in medium chain triglycerides (MCTs) that are fatty acid molecules with 6-12 carbon atom aliphatic chains. The Petition also indicates that foods and beverages that are eligible for the proposed claims would comply with FDA’s regulations regarding health claims at 21 C.F.R. § 101.14, with the exception (via FDA waiver) of the total fat and saturated fat disqualifying levels set forth in 21 C.F.R. § 101.14(a)(4).

UBN requests FDA’s approval of the following proposed qualified health claims: (1) “Supportive, but inconclusive, scientific evidence suggests that consuming at least 1 serving of 5 grams of [Caprylic Acid] daily in a food or beverage containing an Effective Level [80% concentration] creates the ketogenic effect that may reduce the risk of a migraine headache”; and (2) “Daily consumption of a serving of a beverage as a source of [Caprylic Acid], containing at least 5 grams of [Caprylic Acid] at an 80% concentration may reduce the risk of migraines. Fuel for Thought® provides 5 grams of [Caprylic Acid] per serving that, when consumed, has a ketogenic effect per serving of the beverage.”

UBN’s Petition asserts that “ketones are the brain’s preferred alternative fuel source, if supplied in sufficient quantities. As people age or suffer from neurological decline, the brain becomes less able to utilize glucose, its usual source of fuel and brain cells will then begin to decline and die.” The Petition further states that UBN’s coconut oil-based product comprises a “unique formulation [that] provides [MCTs] to quickly increase ketone production to sufficient levels to help in keeping the brain supported in performing its many functions.”

FDA is accepting comments on the Petition until June 29, 2020 (Docket FDA-2020-Q-1295). We will continue to monitor the status of this Petition.

 

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