The Food and Drug Administration has overstepped its bounds by ruling that a study’s endpoints, rather than the intended use of the product or ingredient being studies, determines whether an Investigational New Drug application must be filed in the opinion of VDF Futureceuticals, a dietary supplement ingredient supplier.
FDA recently reopened its comment period on its final guidance on the IND question. VDF Futureceuticals submitted a commentary, making the case that the above position, which is part of the final guidance, serves to squelch new science into the effects and potential benefits of dietary supplement ingredients.
“Our position is that FDA is overstepping the boundaries clearly established in DSHEA and the regulations as defined by Congress,” John Hunter, executive vice president of VDF FutureCeuticals told NutraIngredients-USA. “We don’t think it’s fair when FDA tries to interpret the laws to add new restrictions on the research and development of dietary supplements.”
“FDA’s position to say that if you have a dietary supplement and you intend apply that dietary supplement to a study population that is diseased then it automatically is a drug. We don’t think that is true.
“We believe the intent is to restrict dietary supplements with respect to the claims you can make. We don’t believe that restriction applies to what you can study. It would restrain those of us in the dietary supplement industry who are truly desirous of developing products that have an benefit,” Hunter said.
“I think there are people in government who are uncomfortable with the idea that a dietary supplement could have an actual benefit,” he added.
Confounding language in guidance
In 2010, the FDA issued a draft version of the guidance (see 75 Reg. 63891) with the stated purpose of assisting clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an IND. The draft recognized that an IND is required only for research that involves a "drug," defined in the Federal Food, Drug, and Cosmetic Act to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body," and that "a dietary supplement is not considered a drug....if the intended use for which it is marketed is only to affect the structure or any function of the body."
However, the Draft Guidance also included the contradictory position that "whether an IND is needed for a clinical investigation evaluating a dietary supplement is determined by the intent of the clinical investigation" rather than the "intended use"of the product itself. This language was maintained in the final guidance which was issued by FDA in September 2013. The final guidance can be found here .
Single molecule entities
Hunter said that under FDA’s current stance, its conceivable that a university researcher might be required to file an IND application on blueberries, depending on what the end points of the prospective study might be.
“The IND process was very clearly meant for drugs, for single molecule entities, something brand new created by a pharmaceutical company,” Hunter said. “It was never intended for dietary supplements. It boils down to a fundamental concern about safety and purity and I think in an overabundance of zeal certain decisions were made that clearly overstepped the regulations.”
FutureCeuticals, Inc. is a vertically integrated functional food ingredient, product development, and bioanalytical research and discovery company with farms and facilities in Illinois, Indiana, Wisconsin, California, and Europe.