IT A FOOD, A SUPPLEMENT OR A DRUG?
the Marketing That Counts!
recent article in The Wall Street Journal discussed how producers of
some food products such as cranberry juice, oat meal, walnuts and
grass fed beef are taking a page from the pharmaceutical industry
and marketing their products directly to doctors to “prescribe” to
combination of food and medicine brings to mind the fact that the FDA
has divided products that can be consumed by the body (orally or
intravenously) into three categories: food, dietary supplement and
drug. So in 11,708 regulations or less, what’s the difference? What the product contains?
How the product is made? How it affects the body? Well, the simplified
answer is that in many instances a product’s FDA classification
is based on how you advertise it.
a product is advertised as having a medicinal effect on the body, then
it will likely be classified an OTC or a prescription drug. If a
product is advertised as affecting the body’s “structure/function,”
then it’s likely to be a dietary supplement. If a product is advertised
as “good tasting,” “refreshing,” or with other
adjectives expressing sensory delight, then it’s likely to be
a food. Of course, as far as Mother Nature is concerned, FDA classifications
are meaningless. Whether my product XXXX is classified as a food, dietary
supplement or as a drug, its physiological effect on the body will
be the same.
simplified analysis leaves out some very significant regulatory distinctions
between these classifications such as the fact that (a) the ingredients
in food must be GRAS (but not dietary supplements), (b) any products
that contain a substance that FDA has classified as a drug must be sold
as a drug (c) drugs (but not food or most dietary supplements) need
FDA pre-approval before they go to market and (d) both food and dietary
supplements can make certain types of FDA approved health claims. Nevertheless,
the question of how you will market your product is often as important
as what it is.
often encounter products that are unwittingly being marketed in a manner
that is not consistent with FDA restrictions. Zackler & Associates
knows all (well almost all) the FDA’s 11,798 regulations and
can advise you not only about marketing, but also about product formulation,
labeling, nutritional claims, and other issues pertaining to the regulation
of your product.
Adopts New Trans Fat Labeling
the most significant change in the nutritional labeling rules since
the NLEA rules became effective in 1993, the FDA has mandated that “Nutrition
Facts” and “Supplement Facts” panels will have to
disclose the amount of trans fatty acids in the product. This declaration
is to appear immediately below the declaration for saturated fat. For
products having less than 5 grams of trans fat per serving, the amount
of trans fat should be rounded off to the nearest 0.5 gram and for products
with 5 grams or more of trans fat, the rounding should be to the nearest
whole gram. Products that contain less than 0.5 grams of trans fat will
not be required to declare trans fat if there are no label claims about
fat, fatty acid or cholesterol content. However, the products must state
in a footnote that they are not “a significant source” of
trans fat. Because trans fat is assumed to have no nutritional value,
there will no DRV or DV for it. The new rule will become effective
on January 1, 2006.
new rule also contains a series of conforming amendments that integrate
the trans fat declaration into the currently permitted variations of
the general nutrient labeling requirements such as the qualifications
permitting the use of the simplified labeling format. Also, in order
to correct an inadvertent omission in the original FDA regulations,
saturated fat will have to be declared whenever any nutrient content
claim is made about fatty acids.
further review, the FDA has not approved any on-label nutrient content
claims about trans fat such as “trans fat free” nor has
the FDA specified any benchmark limits that might be imposed on trans
fat containing foods making health claims.
Agrees to Change Fresh Claim in “Pure Premium Orange Juice” Ad
Products, Inc. has agreed to change a television commercial that implied
its Pure Premium Orange Juice was the same as fresh squeezed orange
juice. Tropicana’s change was prompted by a ruling from the National
Advertising Division (“NAD”) criticizing the ad.
subject ad opened with a woman saying, “I love everything about
fresh squeezed orange juice, except the squeezing part - so I pour myself
some Tropicana instead.” Tropicana contended that message of the
ad was only that Tropicana was a great tasting product and good alternative
to squeezing fresh oranges. The competitor challenging the ad before
the NAD contended that the commercial implied that Tropicana was identical
to fresh squeezed juice. The NAD ruled that text and the images from
the commercial would likely confuse consumers into thinking that the
Tropicana product was “fresh.” This impression would be
false because the pasteurized juice did not meet the FDA’s definition
of “fresh” outlined in 21 CFR Section 195.
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