I wonder what this will Entail?
Some of this is 'older' stuff. The "intended use" is the same as I referred to in the nitrous oxide case with balloons, where the balloon vendor was charged even though he sold no nitrous oxide...from my earlier posts. The one doc:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-25/pdf/2015-24313.pdf#page=1
.... spells out the definition (and refers to some of the cases formerly mentioned). (my emphasis)
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)).
3. Intended Use As noted in section I.B.2 of this document,
intended use may be determined from any relevant source and is not based solely on claims made in a product’s labeling or advertising materials. For purposes of illustration, however, claims such as ‘‘treatment of tobacco dependence,’’ ‘‘wean yourself off of nicotine,’’ ‘‘for people who wish to quit smoking,’’ ‘‘stop smoking aid,’’ ‘‘prevent relapse,’’ or ‘‘stay quit’’ generally would fall within the intended uses described in proposed §1100.5(a).10 Claims such as ‘‘to reduce withdrawal symptoms,’’ ‘‘helps reduce symptoms including things like [list of withdrawal symptoms]’’ and ‘‘relieve withdrawal symptoms while you are on the plane’’ would be associated with an intended use for relief of nicotine withdrawal symptoms, and would also fall within the intended uses described in proposed §1100.5(a).
Basically any claim by a vendor that says "you can reduce your nicotine level" would be suspect. Saying that the eliquid comes in 24, 18, 12, 6, 3 and 0. would not likely be suspect, unless the customer then says "So... I can reduce the level of nicotine myself?" and the vendor says "Yes" rather than repeating what is available.
