Provisions as to labels

(1) A label shall afford no defence under section 7 (a)(iii)(A) or (b)(ii)(B), unless the following requirements are satisfied– (a) the label must state explicitly what substance has been added to, or what constituent has been abstracted from, the food or drug; and (b) it must be of adequate size, and have the notice of addition or abstraction distinctly and legibly printed and conspicuously visible. (2) Notwithstanding anything in sub-section (1), the requirements thereof shall, as respects a mixture, be deemed to be satisfied by a label which has been continuously in use without any material variation for a period not less than fifty years and bears a statement to the effect that the article in question is mixed, or by a label which has been continuously in use without any material variation for a period of not less than twenty-five years and bears such a statement distinctly and legibly printed and un-obscured by other matter on the label. (3) A person who sells or otherwise has in his possession for sale any drug shall, notwithstanding any other provision of this Act, ensure that the drug bears a label whether attached to or printed on the wrapper or container or not, for the drug, that sets out the information otherwise under this Act required to be stated thereon,– (a) in English; (b) in English and Spanish; or (c) in Spanish, 18 and, in addition to those language requirements, in any other language that the Minister may prescribe by Order, for the purposes of this sub-section; and in every case the sale or possession shall be in accordance with such other requirements as may be prescribed. (4) A person who contravenes sub-section (3) commits an (5) No persons who sells or otherwise has in his possession for sale any food or drug shall tamper with or remove any label that satisfies the requirements of this Act, whether attached to or printed on the wrapper or container or not, for the food or drug, that sets out the information otherwise under this Act required to be stated thereon.