(b) When any substance which does not reduce, lower, or injuriously affect its quality or strength, is added to a food or drug product, other than that necessary to its manufacture or refining, the label shall bear a statement to that effect.
Regulation 26. Waste Materials.
(Section 8.)
When an article is made up of refuse materials, fragments, or trimmings, the use of the name of the substance from which they are derived, unless accompanied by a statement to that effect, shall be deemed a misbranding. Packages of such materials may be labeled "pieces," "stems," "trimmings," or with some similar appellation.
Regulation 27. Mixtures or Compounds with Distinctive Names.
(Section 8. First proviso under "Foods," paragraph 1.)
(a) The terms "mixtures" and "compounds" are interchangeable and indicate the results of putting together two or more food products.
(b) These mixtures or compounds shall not be imitations of other articles, whether simple, mixed, or compound, or offered for sale under the name of other articles. They shall bear a distinctive name and the name of the place where the mixture or compound has been manufactured or produced.
(c) If the name of the place be one which is found in different States, Territories, or countries, the name of the State, Territory, or country, as well as the name of the place, must be stated.
Regulation 28. Substances Named in Drugs or Foods.
(Section 8. Second under "Drugs"; second under "Foods.")
(a) The term "alcohol" is defined to mean common or ethyl alcohol. No other kind of alcohol is permissible in the manufacture of drugs except as specified in the United States Pharmacopœia or National Formulary.
(b) The words alcohol, morphin, opium, etc., and the quantities and proportions thereof, shall be printed in letters corresponding in size with those prescribed in Regulation 17, paragraph (c).
(c) A drug, or food product except in respect of alcohol, is misbranded in case it fails to bear a statement on the label of the quantity or proportion of any alcohol, morphin, opium, heroin, cocain, alpha or beta eucain, chloroform, cannabis indica, chloral hydrate, or acetanilid, or any derivative or preparation of any such substances contained therein.
(d) A statement of the maximum quantity or proportion of any such substances present will meet the requirements, provided the maximum stated does not vary materially from the average quantity or proportion.
(e) In case the actual quantity or proportion is stated it shall be the average quantity or proportion with the variations noted in Regulation 29.
(f) The following are the principal derivatives and preparations made from the articles which are required to be named upon the label:
Alcohol, Ethyl (Cologne spirits, Grain alcohol, Rectified spirits, Spirits, and Spirits of wine):
Derivatives—
Aldehyd, Ether, Ethyl acetate, Ethyl nitrite, and Paraldehyd.
Preparations containing alcohol—
Bitters, Brandies, Cordials, Elixirs, Essences, Fluidextracts, Spirits, Sirups,
Tinctures, Tonics, Whiskies, and Wines.
