§2.5 Foods for Special Dietary Uses and Food Additives: 1970-1990
| Jurisdiction | United States |
| Publication year | 2022 |
§2.5 Foods for Special Dietary Uses and Food Additives: 1970-1990
During this time, the '38 Act, foods for special dietary uses, and food additives were better defined through regulations and extensive litigation.
In United States v. An Article of Drug . . . Bacto-Unidisk . . ., determining whether an article is a "drug" was once again questioned by the Supreme Court.375 Utilizing the statute, legislative history, and liberal construction of the '38 Act, the court held the articles, an antibiotic sensitivity disc, to be a drug because "drug" as used in the statute has a meaning beyond that of the medical community,
". . . we think it plain that Congress intended to define 'drug' far more broadly than does the medical profession."376
For dietary supplement, herbal remedy, or traditional medicine manufacturers, the specter of having their product classified a "new drug" or a "food additive" was foreboding because of the requirement for pre-market approval for new drugs and food additives.377 In one case, homeopathic remedies were considered drugs based on the owner's own statements that ". . . these remedies . . . treat the patient . . . not just the disease."378 Certain products developed from the proteins of beans, termed "starch blockers," were deemed drugs because of the intended use to address overweight conditions.379 Under FDA regulations, products addressing weight could be classified as "foods for special dietary uses"; however, apparently the sole purpose of "starch blockers" was for their use in treating weight and therefore the FDA classified them as drugs. The lower court held the starch blockers to be "drugs" because food was used ". . . for taste, aroma, or nutritive value"380 and clearly starch blockers were not used for these purposes. On appeal, the Circuit Court concurred that the starch blockers were drugs; however, it deemed the lower courts' use of "food" too restrictive and expanded it to articles ". . . primarily for taste, aroma, or nutritive value."381 Central to the manufacturer's argument was that because the product was "natural," it was a food. This argument was rejected at both levels;
". . . 'food' is to be defined in terms of its function . . . rather than its source, biochemical composition, or ingestibility."
In another case, the uselessness of the "starch blockers" as foods was emphasized by the court when holding they could not be classified as foods.382
As previously examined, labeling can be used to show intent. Labeling that had previously been distributed was used to show the intent of dietary supplement manufacturers, even though the labeling was later revised.383 In that case, the dietary supplement, Exachol, was determined to be both a food and a drug.384
Amendments in 1962 to the Federal Food, Drug, and Cosmetic Act required drugs that were sold after the enactment date to be "effective," as well as safe (previously the only requirement under the '38 Act).385 Pre-market approval of a drug now required substantial research and additional resources. In addition to dietary supplement and herbal remedy manufacturers, pharmaceutical companies often attempted to fall under the grandfather clause to avoid the "effective" requirement.386
For an article to be classified as a "new drug," or a "food additive" under the '58 Amendment, the article should not be GRAS ("generally recognized as safe").387 Individual ingredients that were GRAS did not establish that a product composed of the individual ingredients was GRAS.
In United States v. 7 Cartons, More or Less, Etc., the product, Ferro-Lac, was composed of sodium propionate, sodium phthalysulfacetamide, and methylrosaniline chloride.388 In an affidavit in support of the safety of Ferro-Lac, several different commercial drugs were shown to contain one of the ingredients of Ferro-Lac, but no one drug contained all the ingredients in combination. In three separate affidavits submitted by the Government, three scientists asserted that they had not heard of the three ingredients in combination together and hence were unable to verify that Ferro-Lac had been generally recognized as safe. Whereas an affidavit submitted for Ferro-Lac asserted that theoretically, consuming Ferro-Lac would be the same as consuming the ingredients individually, the court held Ferro-Lac to not be GRAS, and hence it was a "new drug."
"The affidavit contains . . . and inference that safety might be shown by the scientific testing. . . . It is not addressed to the critical test of general recognition in the scientific community . . . to be safe."389
In a later, separate Court of Appeals case adjudicating whether Ferro-Lac was a food additive, the safety (GRAS) assertion of the individual ingredients was again rejected:
"It does not matter . . . if Ferro-Lac is in fact safe or whether the residues would be different if the individual ingredients were tested. The sole criterion for . . . a food additive is whether a substance which may become a component of or affect the characteristics of any food be not generally recognized among qualified experts as . . . safe."390
The safety of individual ingredients being insufficient to show the safety of their combination was reiterated by the courts in other cases.391 However, in a Circuit Court case, the court did not conclusively state that such was the law. An inference was provided where individual ingredient safety showing combination safety was a question to be determined in each case, based on the testimony of experts, i.e., a question of fact.392
Manufacturers were equally reluctant to have their products classified as "food additives" because of the requirement that food additives be pre-approved by the FDA, based on scientific procedures.393 However, in the event a product was classified a "food additive, it could be viewed as GRAS based on its common usage in food before January 1, 1958. The courts determined "common use in food" referred to the usage of the food additive under conditions producing long-term ingestion.394 In an early case that specifically referred to an article being a "dietary supplement," a court found Orotic Acid to be a food for humans, a food additive being manufactured by a fermentation process, and an unsafe food additive because it was not generally recognized as safe among experts based on scientific procedures or common use prior to January 1, 1958, and hence "adulterated" under the statute.395 While this early dietary supplement case set forth the modus operandi for a dietary supplement being deemed adulterated, it did not fully discuss the method of determining a food to a "food additive."
In Monsanto Company v. Kennedy, the Court of Appeals for the District of Columbia set forth that the Commissioner of the FDA has the discretion to determine whether a substance will result in its becoming a component or affecting food, and thus becoming a "food additive,"396
"Congress has granted to the Commissioner a limited but important area of discretion . . . The Commissioner has latitude . . . to find migration 'insignificant' even giving full weight to the public health and welfare concerns that must inform his discretion."397
Most likely, because of the word "additive" in the phrase "food additive, manufacturers attempted to argue that important or principal ingredients" in a food should not be considered "food additives," and thus not subject to evidence of safety.398 The court rejected this argument, holding the term "component" as used in the definition of "food additive meant both large and small quantities of substances.399
The "common use in food" exemption in the '58 Amendment permitted manufacturers to establish an additive was GRAS, provided the additive was used prior to January 1, 1958. This exemption was explicit as to whether the exemption also applied to foreign products used in other countries for years but had not yet been sold in the United States.
Fmali Herb v. Heckler was a case involving an importer of Chinese food products.400 The importer desired to import foods that contained herbs traditionally used in China but not yet used in the United States. One such food product, Ginseng Royal Jelly (renshen fengwangjiang), was not allowed by the FDA to be sold in the United States because it contained schizandra seed (wu wei zi), a substance not scientifically tested and lacking common usage in the United States before 1958. Evidence showing long and widespread use of schizandra seed in China before 1958 was deemed insufficient to the FDA.401 The court, relying upon the legislative record for the '58 Amendment, determined that Congress did not intend for there to be geographical limitation on common usage.402 In holding that a "blanket exclusion of evidence of safety based on use of food outside the United States" failed to comport with the legislative intent for "common use," dicta the court inferred that evidence of foreign use, alone, may not be sufficient to establish safety for an additive.403
To establish common usage in food, an additive must have been used previously under conditions that would be similar to its future or intended use. For example, it was held that common use was not established for a nitrate where its previous use was for foodstuffs but its future or intended use was for beverages.404
The length of time necessary to satisfy "common use" was discussed by the courts.405 Apparently, based on legislative history, focus on the length of time was diminished in favor of the nature of its usage.406
The Fmali Herb case also made reference to the difference between FDA regulations that were legislative or interpretative. As the FDA was not instructed by statute to define "common use in...
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