§2.3 Act of 1938
| Jurisdiction | United States |
| Publication year | 2022 |
§2.3 Act of 1938
The '06 Act was monumental in creating a national food and drug law. However, the Act had many shortcomings, as shown by the court decisions and corresponding congressional amendments redressing the decisions, "Court decisions have revealed textual weaknesses in the measures that were not foreseen when it [1906 Act] was enacted. Very few substantial alterations of the law have been provided through amendments to meet its demonstrated deficiencies."124 Congress began to develop a new food and drug statute that would continue the beneficial aspects of the '06 Act while addressing its shortcomings.
Senate bill 1944 (S. 1944) was introduced in 1933.125 Significant provisions in S. 1944, in comparison to the '06 Act, include:
• expanding the definition of a drug;126
• defining "label";127
• defining "labeling";128
• expansion of adulteration for food;129
• expansion of adulteration for drugs;130
• expansion of misbranding for food and drugs;131
• advertising for food and drugs;132
• authorizing the Secretary of Agriculture to establish "definitions of identity" and "standards of quality" for food;133 and
• administrative provisions for the Secretary of Agriculture.134
Well intentioned, S. 1944 met with opposition from both industry forces and consumer groups.135 S. 1944 eventually died in committee.
Senate bill 2000 (S. 2000) was put forward in 1934 to address the concerns of S. 1944.136 Significant provisions of S. 2000, in comparison to the '06 Act, include:
• expansion of the definition for drug;137
• defining "label";138
• defining "labeling";139
• expansion of adulteration for food;140
• expansion of adulteration for drugs;141
• requiring drugs offered and sold as "homeopathic drugs" to be subject to the requirements of the Homeopathic Pharmacopoeia of the United States;142
• expansion of misbranding for food and drug; drugs supported by "substantial medical opinion" or "demonstrable scientific facts" would not be considered misbranded;143
• introducing misbranding for foods used "for special dietary uses";144
• authorizing the Secretary of Agriculture to establish "definitions" and "minimum standards of quality" for food;145
• administrative provisions for the Secretary of Agriculture;146 and
• vesting jurisdiction with the district courts of the United States to restrain the enforcement of Department of Agriculture's regulations if it is shown the regulation to be ". . . unreasonable, arbitrary, or capricious or not in accordance with the law, and that the petitioner will suffer substantial damage."147
While detailed, there was no full support of S. 2000, and it died in committee.
Senate bill 2800 was put forward in February of 1934.148 Significant provisions of S. 2800, in comparison to '06 Act, include:
• expansion of the definition for drug, with limiting provision that it was ". . . not to regulate the practice of medicine";149
• defining "label";150
• defining "labeling";151
• defining "medical opinion";152
• defining "official compendium";153
• expansion of adulteration for food;154
• expansion of adulteration for drugs, including requiring homeopathic drugs to be subject to the Homeopathic Pharmacopoeia of the United States;155
• expansion of misbranding for food and drug; claims or representations for drugs, if not supported by "substantial medical opinion" or by "demonstrable scientific facts," are determined false;156
• introducing misbranding for foods used "for special dietary uses";157
• authorizing the Secretary of Agriculture to establish "definitions" and "standards of quality" for food;158 and
• vesting jurisdiction with the district courts of the United States to restrain the enforcement of Department of Agriculture regulations if it is shown the regulations to be ". . . unreasonable, arbitrary, or capricious or not in accordance with the law, and that petitioner will suffer substantial damage."159
S. 2800 was amended in March, April, May, and June of 1934.160 Senate Report Number 493 embellished on the reasoning behind S. 2800 provisions.161 Whether an article would be classified a "food" or a "drug" would depend upon the intended use.162 For example, if the article contained nutritive ingredients, but it was sold as a drug only, as shown by the labeling and advertising, it would classify as a drug.163 The definition of "drug" was enlarged in order to include "slenderizers" that were deemed worthless and dangerous.164 The expansion of adulteration for "drug" was done to address articles that were dangerous but bore no false or misleading statements and thus could not be acted against.165 In comparison to the '06 Act, the requirement of "fraudulent" for misbranding was removed. The burden on the Government to show fraudulence was deemed a serious handicap and of no consequence to whether the representations were made in good faith or not.166 Drugs that were recognized in the Homeopathic Pharmacopoeia of the United States were brought under the provisions of S. 2800.
Adulteration of food was expanded because whether a "poison" is added or occurred naturally is irrelevant to the health of the consumer.167 The phrase "may render" in the adulteration provision possessed the same reason it had under the '06 Act.168
"Label" and "labeling" were distinguished because the necessary, required information to inform consumers about the constituents of an article should be placed on the "label" as opposed to the "labeling."169
Under S. 2800, misbranding of drugs was deemed to occur if statements as to the efficacy of a drug were not supported by substantial medical opinion or by demonstrable facts.170 "Substantial medical opinion" was defined as the "contemporary opinion shared by some numerically significant group, including recognized experts in the field in question."171 The requirement for "substantial medical opinion" was done to remove mere speculative theories for supporting claims about the efficacy of a drug. It was not intended to discourage research for new remedies or new uses of old remedies.172 Drugs that were not a specific cure for a disease but which were a "palliative" of a stated disease were deemed misbranded if they did not indicate they were a palliative and how the palliation was affected.173 In the case of self-medicating drugs, the bill was stated as ". . . contribut[ing] to the safety of self-medication by preventing medicines from being sold as 'cures' unless they really were cures."174
Regarding setting definitions and standards of identity for food, it was stated that the absence of such was a serious handicap under the '06 Act.175 In the case of dietary foods, the bill required proper, informative labeling.176
A provision for review of Department of Agriculture regulations by the federal courts was done to insure a safe and prompt review. Any party that would suffer substantial damage of a regulation would be allowed to file a petition for review.177
Well intentioned, S. 2800 died after debate.
Senate bill number S. 5 was introduced in 1935.178 Significant provisions in comparison to the '06 Act included:
• citing the act as the "Federal Food, Drugs, and Cosmetic Act";179
• expanding the definition of "drug";180
• defining "label";181
• defining "labeling";182
• expanding adulteration for food;183
• expanding misbranding of foods;184
• misbranding foods "for special dietary uses" if required by regulations, to provide statements concerning vitamin, mineral, and other dietary properties that fully inform of nutritional value;185
• fixing and establishing for any food a "definition" and "standard of identity";186
• expanding adulteration for drugs;187
• subjecting a drug labeled and offered for sale as a homeopathic drug to the provisions of the Homeopathic Pharmacopoeia of the United States;188
• requiring drugs fabricated from two or more ingredients to place on its label the names and quantity or proportion of each active ingredient;189
• requiring advertised representations for food or drugs to be sustained by "demonstrable scientific facts or substantial medical opinion";190
• making it unlawful to advertise for sale a drug represented to have any therapeutic effect in the treatment of cancer;191
• vesting authority in the Secretary of the Agriculture to make regulations for enforcement of the act;192 and
• vesting authority in the federal district courts to restrain by injunction enforcement of regulations if it is shown the regulations are "unreasonable, arbitrary, or capricious, or not in accordance with law, and that the petitioner will suffer substantial damage by reason of its enforcement." Complaints may be filed by interested persons.193
S. 5 was amended in February, March, and May of 1935. The congressional reports accompanying the bill and corresponding amendments detailed the reasoning behind the provisions and changes thereto. The adulteration of food in Section 301(a)(1) was changed to occur when food bears a substance that may be "dangerous" to health as opposed to "injurious." This modification was done to avoid interferences with natural products like "rhubarb, which contains oxalic acid."194 It was noted that the science of nutrition was expanding with a provision directed to "special dietary foods."195
Explanations in Senate Report 646 (S. Rept. 646) for amendments to S. 5 were similar to those provided for S. 2800 in S. Rept. No. 493.196 Further, S. Rept. 646 indicated that one reason for expanding the definition of "drug" was to include articles that were intended to affect the structure and function of the body.197 It noted Section 402(f) was useful in allowing self-medicating consumers to know the drugs he was taking based on its identity. To that end, drugs sold as other than pharmacopoeial or formulary preparations should be labeled with their common or usual name.198 Section 601(b) regarding false advertising for self-medicating drugs was added to stop the advertising of...
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