2023 Maryland Statutes › Health - General › Title 21 - Food, Drugs, and Cosmetics › Subtitle 2 - Maryland Food, Drug, and Cosmetic Act › Part VI - Enforcement of Subtitle; Prohibited Acts › Section 21-259.3 - Animal Testing Prohibited in Development of Cosmetic -- Inapplicable to Certain Animal Testing -- Local Law on Animal Testing Prohibited -- Civil Penalties -- Enforcement

(a)    (1)    In this section the following words have the meanings indicated.
(2)    “Animal testing” means the internal or external application or exposure of a cosmetic or any component of a cosmetic to the skin, eye, or any other body part of a live nonhuman vertebrate.
(3)    “Ingredient” has the meaning stated in 21 C.F.R. § 700.3(e).
(4)    “Manufacturer” means any person whose name appears on the label of a cosmetic in accordance with the requirements of 21 C.F.R. § 701.12.
(b)    (1)    Except as provided in subsection (c) of this section, a person may not conduct or contract for animal testing in the development of a cosmetic.
(2)    Except as provided in subsection (c) of this section, beginning July 1, 2022, a manufacturer may not sell or offer for sale in the State a cosmetic if the manufacturer knows or reasonably should have known that the final product or any individual component of the final product was developed or manufactured using animal testing that was conducted or contracted by or for the manufacturer or any entity that supplies, directly or through a third party, any ingredient used by a manufacturer in the formulation of a cosmetic on or after January 1, 2022.
(c)    The provisions of subsection (b) of this section do not apply to animal testing that is:
(1)    Conducted or contracted to comply with a requirement of a federal or state regulatory agency if:
(i)    The cosmetic or ingredient in the cosmetic that is tested is in wide use and cannot be replaced by another ingredient that is capable of performing a similar function in the product;
(ii)    A specific human health problem relating to the cosmetic or an ingredient in the cosmetic is substantiated and the need to conduct animal testing is justified and supported by a detailed protocol for research that is proposed as the basis for the evaluation of the cosmetic or ingredient in the cosmetic; and
(iii)    Animal testing is the only method of testing that is accepted for the relevant purpose by the federal or state regulatory agency;
(2)    Conducted or contracted to comply with the requirement of a regulatory agency of a foreign jurisdiction if:
(i)    No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; and
(ii)    The testing was not conducted in the State;
(3)    Performed on a cosmetic or an ingredient in a cosmetic subject to the requirements of Subchapter V of the Federal Food, Drug, and Cosmetic Act;
(4)    Conducted or contracted to comply with a requirement of a federal, state, or foreign regulatory agency for purposes unrelated to cosmetics testing if:
(i)    No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; or
(ii)    1.    Documentary evidence demonstrates that the intent of the test that was performed was unrelated to cosmetics testing; and
2.    The ingredient that was the subject of the testing has been used for purposes unrelated to cosmetics for at least 12 months; or
(5)    Performed on:
(i)    A cosmetic that, in its final form, was tested on animals before January 1, 2022, whether or not the cosmetic is manufactured on or after January 1, 2022; or
(ii)    A cosmetic ingredient that was sold in the State and tested on animals before January 1, 2022, whether or not the ingredient is manufactured on or after January 1, 2022, if any animal testing of the cosmetic ingredient after January 1, 2022, is conducted or relied on in accordance with this section.
(d)    This section may not be construed to prevent a cosmetics manufacturer from reviewing, assessing, or retaining data resulting from animal testing.
(e)    A political subdivision of the State may not adopt or enforce a provision of a local law relating to animal testing on cosmetics or animal testing on ingredients used in cosmetics.
(f)    (1)    A person who violates this section is subject to a civil penalty:
(i)    Not exceeding $5,000 for the first offense; and
(ii)    Not exceeding $1,000 for each subsequent offense.
(2)    Each violation of this section with respect to a separate animal and each day on which a violation occurs is a separate violation under this section.
(3)    If a person who is alleged to have violated this section claims the prohibition in subsection (b) of this section does not apply because the testing falls under subsection (c)(1)(ii) of this section, the person shall provide clear, documented evidence of the date on which the data were generated.
(g)    (1)    A local law enforcement agency may enforce the provisions of this section.
(2)    (i)    The State’s Attorney for each county may seek appropriate relief for violations of this section.
(ii)    A State’s Attorney, in determining whether a violation of this section occurred, may review any testing data on which a manufacturer has relied in determining the safety of a cosmetic or an ingredient in a cosmetic sold in the State.
(iii)    Any testing data reviewed under subparagraph (ii) of this paragraph is entitled to protection as a trade secret.