CHAPTER IV.

ADULTERATION.

25. ADULTERATION.

To the manufacturer of or dealer in food or drug products it is of the utmost importance to clearly understand what is meant by "adulteration" and "misbranding" as used in the Act. Adulteration in its ordinary definition of making impure by admixture of cheaper or inferior ingredients is obviously included, but it is also evident that the term as used in the Act has a broader meaning and includes the use in food or drug products of substances not ordinarily considered adulterants. Broadly speaking, the Act prohibits as adulterated any food or drug product that is below an established or recognized standard of strength, quality, or purity, or that contains any added ingredient which is deleterious or detrimental to health, or which contains any substance specifically prohibited by the Act. To this broad statement there are many exceptions provided for in the Act, and in fact the Act is not to be understood as absolutely prohibiting adulterated foods or drugs even in the ordinary sense of adulteration provided they are plainly and correctly labeled or branded. It does, however, prohibit all adulterated foods or drugs which are not plainly and correctly labeled or branded in accordance with the requirements of the Act, and absolutely prohibits the use of certain substances in foods or drugs, whether specified on the label or not.

26. ADULTERATION-DRUGS-DRUG STANDARDS.

In order to determine whether or not an article of food or drug shall be considered to be adulterated within the

meaning of the Act, it is necessary to compare it with some standard definition or description of the article in question, either a generally accepted definition or a definition or description arbitrarily adopted as a standard.

The United States Pharmacopoeia or National Formulary is accepted by the Act as correctly defining or describing the strength, quality, and purity of each drug named in it. Unless otherwise plainly stated on its label, any drug sold or offered for sale under or by the name of a drug which is defined or described in the Pharmacopoeia or National Formulary must conform to the standard of strength, quality, and purity as determined by the test for such drug therein laid down.

If plainly stated to differ in strength, quality, or purity from the definition or description stated in the Pharmacopoeia or National Formulary a drug will not. be deemed adulterated provided it is plainly stated on the label what its standard of strength, quality, or purity is, and if in fact it conforms to the statement on the label. With regard to mixtures of substances put up according to a recognized formula, but of half strength, it will be sufficient if the package or bottle is marked "1⁄2 Strength."

The first paragraph of Section 733 under "drugs" appears to relate to substances and mixtures of substances sold under or by a name recognized in the Pharmacopoeia or National Formulary.

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The second paragraph relates to drugs generally, whether named in the Pharmacopoeia or National Formulary or not, and is clearly intended to include the so-called "Patent" or proprietary medicines. It requires that these as well as all drugs must be in strength and purity up to the professed standard or quality under which they are sold.

In the States the requirements of this Section apply only to drugs in original unbroken packages and not to physicians' prescriptions compounded within the State in which

Foods-Food Standards.

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they are sold, but does apply to prescriptions which are shipped out of the State.35

In the District of Columbia and the Territories the requirements of this Section apply to drugs in original unbroken packages, and also apply to prescriptions compounded in the District or the Territory.

The United States Pharmacopoeia or National Formulary to be taken as determining the standard is prescribed by this section to be that official at the time of investigation. It is understood that the Pharmacopoeia is now being or is about to be revised.

27. ADULTERATION-FOODS-FOOD STANDARDS.

The present Act does not expressly adopt or authorize the establishment of any standards for food products. Under the Agricultural Appropriation Act of March 3, 1903, provision is made for the investigation of the adulteration of foods, condiments, beverages and drugs and also "to enable the Secretary of Agriculture in collaboration with the Association of Official Agricultural Chemists, and such other experts as he may deem necessary, to establish standards of purity for food products and to determine what are regarded as adulteration therein," and in accordance with the provisions of that Act the Department of Agriculture has published as Circular No. 1936 standards of purity for a large number of food products, and standards for other food products are in preparation.

The standards as published in this circular No. 19,36 with a few exceptions, such as ice cream in which the percentage of butter fat required (14%), is considered by many manufacturers to be too high, appear to have been generally regarded as correctly describing the various articles of food mentioned in it as manufactured and sold by those who aim to manufacture or to deal in pure food products. While it is doubtful whether the standards established under the authority of the Act of March 3, 1903, are controlling as

determining what shall be deemed adulterations of food products under the present Act, such standards are entitled to great weight and will be regarded by the Courts in any proceedings brought under this Act, as persuasive if not authoritative. In so far as these standards conform in their definition of various articles of food to the standard recognized in the trade, the "Trade Description" as it is termed in the British Merchandise Marks Act, they will be regarded as the standards by comparisons with which adulterations are to be determined.

28. ADULTERATION-FOODS-ADMIXTURE OF INFERIOR IN

GREDIENTS.

Under the first and second paragraphs under "food" in Section 7,37 an article of food is to be deemed adulterated if any substance has been mixed or packed with it so as to reduce, or lower, or injuriously affect its quality or strength, or if any substance has been substituted wholly or in part for it.

The adulteration prohibited by these paragraphs is the common form of adulteration consisting in the admixture or substitution in food products of a cheaper or inferior, though not necessarily or usually harmful, substance, a species of commercial fraud by which the food value of the product is lessened, the object of such adulteration being to reduce the cost to the producer and to enable him by passing it off upon the consumer as of full value, to secure a larger profit than could be made by furnishing an article of standard quality and strength.

Among the food products which have heretofore been found to be particularly liable to this form of adulteration are milk, vinegar, flavoring extracts, confectionery, jellies, jams, preserves, cocoa, honey, butter, molasses, spices, coffee, olive oil, and baking powder.

If the adulteration is carried to the extent of wholly sub

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stituting another substance for the pure article it clearly comes under the prohibition of the first paragraph. If not carried to the extent of complete substitution, it would seem to be covered by either paragraph, the second paragraph appearing to cover such substitution whether or not the quality or strength is reduced, or lowered, or injuriously affected. A claim that the product resulting from the admixture of another substance is better or more wholesome than the pure article is clearly no defense to a charge of violation of these or any other provisions of the Act.

These paragraphs of this Section of the Act are to be read with Section 888 relating to misbranding under which mixtures, compounds, imitations or blends are permitted if plainly so labeled.

Construing these paragraphs of Section 77 with Section 8,38 they appear to prohibit the admixture with or substitution in an article of food of any mineral substance, or any inert substance, and to prohibit the admixture of any substance unless the resulting product is plainly stated to be a mixture, compound or blend and the name of the added substance is also stated.

Proprietary foods seem to be excepted from the provisions of these two paragraphs of Section 7 if known under their own distinctive names and not an imitation of or offered for sale under the distinctive name of another article, provided the name be accompanied with a statement of the place of manufacture.

Imitation foods10 seem to be also excepted from the provisions of these paragraphs of Section 7 if plainly stated to be imitations.

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Under Regulation 11,"1 these paragraphs of Section 7 are construed not to prohibit substances properly used in the preparation of food products for clarification or refining and eliminated in the further process of manufacture. This regulation clearly indicates, as has been above pointed out,

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