Regulation of Functional Food
Functional
foods are generally considered to offer additional benefits beyond basic
nutrition that may reduce the risk of disease or promote optimal health[1] The FLAVR SAVR tomato, a tomato which
took longer to ripen and thus extended its life, was the first genetically
engineered crop product to be granted a license for human consumption.[2] Increasing vitamins, reduce fat, adding
omega-3 are all different ways to convert conventional foods into functional
foods. As biotechnology advances,
so do the ways in which humans can continue to enhance the food produced today.
Since this is inherently a
new way of growing food, how do we make sure that it meets the minimum
standards for health and safety for general public consumption? From a legal perspective, there is no
separate regulatory category for functional food. It is subject to the same regulatory requirements
as any other food, which is governed by the Federal Food Drug and Cosmetic Act
(FFDCA).[3] This means that a functional food may be
regulated as drug or food. If it is
regulated as a food it can fall under one of the following categories: conventional food, dietary supplement, special
dietary use, or medical food.[4]
Drug
A drug is defined by the FFDA as Òa product intended
to diagnose, prevent, treat, or mitigate disease.Ó If functional food is
classified as a drug, it must go under greater regulatory scrutiny than food. The food must be demonstrated to be safe
and effective for their intended use (e.g. clinical trials), and may bear only
FDA-approved labeling.
Today, since functional food is still in essence
ÒfoodÓ, it does not make sense to hold it to this level of regulation. However if food does go on to boast that
it can prevent or cure disease, it may make sense to put it through this level
of scrutiny.
Conventional Food
Conventional food is
described by the FFDCA as a product used primarily for taste, aroma, or
nutritive value, and in a conventional food form. In this category, the ingredients in the
food must be generally recognized as safe for their intended use. If a substance is a food additive, it
requires pre-market clearances from FDA.
A conventional food may be freely marketed on the
basis of taste, and enjoys some flexibility by not needing to be pre-approved
by the FDA before releasing to market nor accompanied by a disclaimer.
Dietary Supplement
A dietary supplement is a product intended to supplement
the diet which must contain one or more Òdietary ingredientsÓ (e.g., vitamins),
be intended for ingestion, labeled as a dietary supplement. Safety requirements for dietary
supplements are less stringent than those for conventional food. The safety
standard for dietary supplements provides that dietary supplements must not
present Òa significant or unreasonable risk of illness or injuryÓ under the
conditions of use.[5]
Food for Special Dietary Use
This category of food is food intended for supplying dietary
needs, such as weight loss medication.
While the definition seems a bit broad, the FDA has some restrictions on
the level of nutrients that differentiate food for special dietary use from
other food.
Medical Food
Medical food is food intended for use under the
supervision of a physician for the dietary management of disease with distinct
nutritional requirements.[6] The ingredients of medical food must be generally
regarded as safe for their intended use. Medical food is entitled to the most
flexibility of all when dealing with regulation, but is permitted in extremely
defined circumstances.
As biotechnology becomes more and more relevant in the
food humans grow and it, it will most likely, if it has not already, challenge
the boundaries of the current existing categories and may warrant its own
category in the near future so that the safety and quality of the new products
can be properly managed.
[1]What are functional foods? http://www.mayoclinic.com/health/functional-foods/AN02088
[2]http://ucanr.org/repository/cao/landingpage.cfm?article=ca.v054n04p6&fulltext=yes
[3]US Food and Drug Administration, http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm
[4]http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/PIFB_Functional_Foods.pdf, 37
[5] FFDCA ¤ 402(f)(1)
[6]http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/ucm054048.htm