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Cal. Health & Safety Code § 111375

Misbranded Drugs or Devices

Known as the Sherman Food, Drug, and Cosmetic Law

The act spans §§ 109875–111929 (490 sections).

Applied in 1 court decision — leading case Zeltiq Aesthetics, Inc. v. BTL Industries, Inc. (2014)

Most recently applied in Zeltiq Aesthetics, Inc. v. BTL Industries, Inc. (March 2014)

Added by Stats. 1995, Ch. 415, Sec. 6

Any drug or device is misbranded unless its labeling bears all of the following information:

(a) Adequate directions for use.

(b) Such adequate warnings against use in pathological conditions or by children where its use may be dangerous to health.

(c) Adequate warning against unsafe dosage or methods or duration of administration or application.

Warnings shall be in a manner and form as are necessary for the protection of users.

If the department determines that any requirement of subdivision (a), as applied to any drug or device, is not necessary for the protection of the public health, the department may adopt regulations exempting the drug or device from these requirements.

Any drug or device exempted under Section 502(f) of the federal act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this section. The department, however, may adopt any regulation including a drug or device within, or excluding a drug or device from the requirements of this section, whether or not the inclusion or exclusion of the drug or device is in accord with the federal act.

Official source: California Legislative Information. Reproduced from public-domain California statutes; confirm against the official source for the current text. Not legal advice.