United States v. ARTICLES OF FOOD & DRUG, COLI-TROL 80 MED.
| Decision Date | 22 February 1974 |
| Docket Number | Civ. A. No. 1413. |
| Citation | 372 F. Supp. 915 |
| Parties | UNITED STATES of America, Plaintiff, v. ARTICLES OF FOOD AND DRUG COLI-TROL 80 MEDICATED, Defendant. |
| Court | U.S. District Court — Northern District of Georgia |
John W. Stokes, Jr., U. S. Atty., Beverly B. Bates, Asst. U. S. Atty., Atlanta, Ga., Jay H. Geller, Atty., Dept. of HEW, Los Angeles, Cal., for plaintiff.
O. J. Taylor, Neale, Newman, Bradshaw & Freeman, Springfield, Mo., R. Wilson Smith, Jr., Gainesville, Ga., for defendant.
This is a seizure action brought under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 334, to condemn a quantity of each of several articles of new animal drugs and foods. The complaint filed on September 27, 1971, alleged that the five articles were adulterated within the meaning of 21 U.S.C. § 351(a)(5) and misbranded within the meaning of 21 U.S.C. § 352(a). Additionally, one article was alleged to be a food additive and adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C). Naremco, Inc. of Springfield, Missouri, intervened and filed claims as to all six articles.
At trial, the claim was waived by Naremco as to Coli-Trol 80 Medicated. It was stipulated that all the remaining articles were seized in interstate commerce and that the following constituted animal drugs within contemplation of the Act:1
Mycotrol P Entrol S Entrol P F4C-60.
The following was stipulated as a food:2
Myconox-LF.
It was likewise stipulated that there is not now and never has been an approved new animal drug application in effect for the four drugs under 21 U.S.C. § 360b(b); nor is there any exemption in effect for the article of food pursuant to 21 U.S.C. § 348.
Thus at issue were the adulteration, or "new animal drug" questions plus the misbranding questions as to the four drugs; and the adulteration or "food additive" question as to the article of food. Stated differently, and giving due consideration to the burden of proof placed on the government throughout the trial3 the questions for determination are:
This is another in a continuing series of contests between the Food and Drug Administration and Naremco over the suitability of the latter's divers veterinary products for public sale and consumption.7 The particular products, with the exception of F4C-60, all contain a composition of small quantities of "gentian violet" (Methylrosaniline chloride) together with sodium propionate, vitamins and minerals.8 F4C-60 contains a composition of chelated irons, copper and cobalt. All contain inert fillers. Generally, it is contended that the gentian violet-based products are effective in the control of the organisms of candida albicans, streptococci, and staphylococci as a cause of difficulties in the digestive tracts of poultry and swine. F4C-60 is represented as effective in the control of iron deficiency anemia in both poultry and livestock.
Virtually all of the ingredients, save gentian violet, are approved for unrestricted use or are within tolerances set for use by the Food and Drug Administration. 21 CFR 121.101. The contest here revolves primarily around gentian violet. It has been used for decades as a fungicide and bactericide by man, and in the lay sense is recognized as safe and effective for human oral and vaginal consumption, as well as for topical application. A number of patent medicines containing gentian violet are available over-the-counter as old-fashioned remedies for sores, pinworms, thrush and various fungi-aided parasites. The basis of acceptance of gentian violet for human use is that experience shows it "just works." There is no study or scientific data on which to base its safety or effectiveness for humans. Claimant's theory is that the passage of gentian violet to the digestive tract of swine and poultry inhibits the growth of harmful organisms as a form of topical application. It is not shown, however, that it can be absorbed by animals out of the mucous-membranes of the digestive tract and into the bloodstream. Myconox as a feed mixture seeks to control the growth of fungi which promotes growth of the organisms in question prior to consumption.
There is no evidence that gentian violet is not safe for animal consumption. There is no evidence that gentian violet in combination with the other ingredients in the four products is not safe for consumption. Accordingly, the court finds as a matter of fact that all five articles in dispute are safe.
As to effectiveness, it appears that the gentian violet based products do, in fact, inhibit the growth of the offending organisms in vitro, and there is no evidence they do not do so in vivo. The problem lies in the need to do so. Increased use of antibiotics sometimes increases the growth in animals of the organisms which are present in all, but normally controlled by nature's balance, through flora. The incidence of the likelihood of any problem therefrom is minuscule. However, there is no evidence that they are not effective if there were such a problem. As in humans, the evidence preponderates to a finding that the drugs "just work." In the case of F4C-60, the problem is even more difficult to isolate. Iron deficiency is simply not an animal problem to any measureable degree. The chelated minerals are more readily absorbed, however; and if there exists a problem of iron deficiency it seems obvious that the addition of iron in any quantity would be effective in reducing the deficiency. Accordingly, the court finds that all of the articles are, in fact, effective.
To this extent, there is likewise no misbranding. However F4C-60 is also represented to be effective against "stress" in a flock or herd. As the court understands, stress in the veterinary concept means nervousness, excitement, strain, exhibited by impulsive physical activity such as "packing", cannibalism and the like. In the vernacular, the flock is "off their feed." There is no known way that minerals can affect stress inasmuch as they are not tranquilizers. Accordingly, as to F4C-60, there is misbranding in that the label is false and misleading in its representation as to effectiveness against stress.
As to all five articles, there are no controlled published studies and no scientific data of in vivos tests of their safety and effectiveness. Contemporaneous or subsequent to this seizure, some tests have been undertaken seeking to demonstrate both safety and effectiveness of these or similar products. However, the results as yet are inconclusive, undistributed, and unknown except to the researchers and Naremco themselves. The completeness and validity of such tests are also open to question. A representative group of qualified research veterinarians, nutritionists, clinicians, pathologists, and microbiologists have never heard of the products by name and have never read or heard of the safety or effectiveness of the ingredients in the combinations formulated in these products. A number of poultry and swine servicemen and salesmen believe from field experience that the products are safe and effective for the uses intended. The current researchers also share this belief from in vitro tests and the limited in vivo tests underway.
The factual findings in relation to these articles may be summarized as follows:
-----------||--------------------------------------------------------------
ARTICLE || COMPONENTS | COMBINATION | RECOGNIZED | MISLEADING |
|| SHOWN TO BE | SHOWN TO BE | BODY OF | LABEL |
|| SAFE | SAFE AND | RESEARCH DATA | |
|| | EFFECTIVE | ON SAFETY AND | |
|| | | EFFECTIVENESS | |
-----------||-------------|-------------|---------------|-----------------|
MYCOTROL P || YES | YES | NO | NO |
-----------||-------------|-------------|---------------|-----------------|
ENTROL S || YES | YES | NO | NO |
-----------||-------------|-------------|---------------|-----------------|
ENTROL P || YES | YES | NO | NO |
-----------||-------------|-------------|---------------|-----------------|
F4C-60 || YES | YES | NO | YES |
-----------||-------------|-------------|---------------|-----------------|
MYCONOX-LF || YES | YES | NO | |
(Safety || | | | |
only) || | | | |
-----------||-------------|-------------|---------------|-----------------|
CONCLUSIONS OF LAW
Were it not for a series of recent Supreme Court decisions construing the 1962 amendments to the Food and Drug Laws,9 this case would be most difficult to resolve. As seen, the court has determined that claimant's products are safe and effective. More properly stated, it has not been shown by a preponderance of the evidence that they are unsafe and ineffective. While it is apparent that the advertised need for the products is largely illusory, the court is persuaded that their use will not result in any harm and could help in isolated instances. While their need might be compared to the proverbial utility of a "wart on a toad-frog," such considerations are not the purpose of the present inquiry and no greater harm is seen to the public from their use than from several celebrated tonics and remedies now legitimately pushed on the market for humans.
However, in view of the important purposes behind the Food and Drug Laws, the statutory scheme, as approved by the courts, does not admit approval of such products...
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