391-O - Sale or Promotional Distribution of Dietary Supplements Containing Ephedra.

NY Gen Bus L § 391-O (2019) (N/A)
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(a) "dietary supplement" means (1) a product (other than tobacco) that is intended to supplement the diet and that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for the use by a person to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients; (2) intended for ingestion in pill, capsule, tablet, or liquid form; and (3) labeled as a "dietary supplement" pursuant to the federal Dietary Supplement Health and Education Act, 21 U.S.C. 321, as amended.

(b) "ephedra" means any natural or synthetic form of ephedrine and ephedrine alkaloids. 3. (a) Nothing in this section shall apply to nonprescription over-the-counter drugs approved or regulated by the Food and Drug Administration.

(b) This section shall not apply to ma huang (ephedra sinica) sold or dispensed by any practitioner of oriental medicine, whose qualification to use ma huang and other herbs is explicitly established via evidence of an active certification issued to such individual from an entity accredited by the National Commission of Certifying Agencies (NCCA) and who is not otherwise required to be licensed by the state of New York, or any physician or any practitioner of acupuncture licensed by the state of New York as long as it is not sold or dispensed as a dietary supplement for weight loss, for body building, or as an "energy food". 4. Any person, firm, corporation, partnership, association, limited liability company, or other entity that violates the provisions of this section by selling, offering to sell, or giving away as either a retail or wholesale promotion, a dietary supplement containing any quantity of ephedrine alkaloids shall be subject to a civil penalty of not more than five hundred dollars per violation, recoverable in an action by any enforcement authority designated by any municipality or political subdivision. 5. It shall be a defense that any person, firm, corporation, partnership, association, limited liability company, or other entity that sold, offered for sale, or gave away as either a retail or wholesale promotion a dietary supplement, did not have knowledge that the supplement contained any quantity of ephedrine alkaloids, if such knowledge was not reasonably discoverable.