Here is an exert from the FDA Clarification...
"2. How Intended Use Is Determined
In determining a product’s intended use, the Agency may look to “any . . . relevant
source,” including but not limited to the product’s labeling, promotional claims, and advertising
(see, e.g., Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); United
States v. Storage Spaces Designated Nos. “8” and “49,” 777 F.2d 1363, 1366 (9th Cir. 1985),
Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff’d, 540 F.2d 947 (8th Cir. 1976)).
For example, FDA may take into account any claim or statement made by or on behalf of a
manufacturer that explicitly or implicitly promotes a product for a particular use (see, e.g.,
§ 201.128 (drugs), § 801.4 (devices)).
To establish a product’s intended use, FDA is not bound by the manufacturer or
distributor’s subjective claims of intent, but rather can consider objective evidence, which may
include a variety of direct and circumstantial evidence. Thus, FDA may also take into account
any circumstances surrounding the distribution of the product or the context in which it is sold
(see id.; see also U.S. v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)). In the context of
medical products, generally, circumstantial evidence often ensures that FDA is able to hold
accountable firms that attempt to evade FDA medical product regulation by avoiding making
express claims about their products. As FDA has previously stated, however, the Agency would
not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by
doctors for such use (Ref. 5).
Thus, when a product made or derived from tobacco is marketed or distributed for an
intended use that falls within the drug/device definitions, it would be regulated as a medical
product, subject to the limitations discussed further in this document. Courts have recognized
that products made or derived from tobacco marketed with “disease” claims and certain
“structure/function” claims are drugs (see United States v. 46 Cartons . . . Containing Fairfax
Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953) (cigarettes marketed for the prevention of
respiratory diseases); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178
F.Supp. 847, 851 (D. N.J. 1959) (cigarettes marketed for weight reduction))."
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