Time to expand the definition of “ingestion” under DSHEA

logo1cIn recent years more and more drugs, both OTC and prescription, have been made available with nasal inhalation delivery systems. Most recently, the FDA announced approval of inhaled insulin. More and more drugs are being delivered intranasally. However, nasal delivery systems remain off-limits to supplement makers.

Under the Dietary Supplement Health and Education Act (DSHEA), for a product to be considered a dietary supplement it must be “ingested.” See 21 U.S.C. § 321 (ff)(2)(A)(I). While it could be argued that ingestion could occur intranasally, one court that addressed the issue determined that the method of intake of a nasal gel product precluded it from being considered a dietary supplement. See U.S. v. Ten Cartons, Ener-B Nasal Gel, 888 F. Supp. 381 (E.D.N.Y. 1995). On appeal, the Second Circuit Court of Appeals did not reach the issue and affirmed on other grounds. See U.S. v. Ten Cartons, Ener-B Nasal Gel, 72 F.3d 285 (2nd Cir. 1995).

As a result of the Ten Cartons decision, supplement makers need to exercize caution when marketing products in nasal spray form. Why should nasal administration, a viable form of drug delivery, remain out of reach of supplement makers? Perhaps it’s time to reexamine the definition of “ingestion” under DSHEA and allow supplements to be sold in nasal spray form.

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Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

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Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

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