In the Matter of the Complaint Against ATHENA PRODUCTS, LTD. at 780 Morosgo Dr., N.E. P. O Box 14152 Atlanta, GA 30324 and at 3545 Broad Street P.O. Box 81112 Chambles, GA 30366 and at 3104 Briarcliff Rd., N.E. P.O. Box 29501 Atlanta, GA 30359 and at 5999 New Peachtree Rd. P.O. Box 48392 Doraville, GA 30362 and at 520 W. Ponce de Leon Avenue P.O. Box 757 Decatur, GA 30030 and at 15 Franklin Street P.O. Box 311 Avondale Estates, GA 30002 and at 3104 Briarcliff Rd., N.E. P.O. Box 98377 Atlanta, GA 30329 and at 3328 E. Ponce de Leon Ave. P.O. Box 893 Scottsdale, GA 30079 and at 4 Executive Park Drive, N.E. P.O. Box 95294 Atlanta, GA 30347 and at 4 Executive Park Drive P.O. Box 95276 Atlanta, GA 30347 and at P.O. Box 8384 Coral Springs, FL 33065 and at 250 Corey Avenue P.O. Box 67112 St. Petersburg Beach, FL 33736 P.S. Docket No. 11/107; 10/22/81 Grant, Quentin E. APPEARANCE FOR COMPLAINANT: Dani el E. Lewis, Esq. Consumer Protection Division Law Department U.S. Postal Service Washington, DC 20260-1100 APPEARANCE FOR RESPONDENT: Thomas Benham, Esq. Benham & Cohen 6600 Powers Ferry Road Atlanta, GA 30339
The Complaint, filed June 8, 1981, in this proceeding alleges that Respondent is in violation of 39 U.S.C. § 3005 by engaging in a scheme or device to obtain money or property through the mails by means of false representations concerning its product, Super RNA Complex. The specific allegations of misrepresentation are set forth in the Findings of Fact, below.
Respondent's Answer denies all allegations of the Complaint and sets forth defenses based on the Constitution of the United States, specifically that 39 U.S.C. § 3005 and the Rules of Practice adopted pursuant thereto are unconstitutional under the first and fourteenth amendments.
A hearing was held in Atlanta, Georgia, on August 26, 1981.
The parties have submitted proposed findings of fact, conclusions of law, and written argument. To the extent indicated they have been adopted. Otherwise, they have been rejected as irrelevant, immaterial, or contrary to the evidence.
Witnesses testifying for Complainant were Michael Flynn, a Postal Inspector, and Nancy Jo Balter, an assistant research professor of biology at Georgetown University, Washington, D.C. William Saunders, M.D., and Richard Lord, a professor of chemistry at Life Chiropractic College, Marietta, Georgia, testified for Respondent.
11. Respondent, through advertisements appearing in SOMA Magazine and Athena Health and Beauty News, solicits remittances of money through the mails to the addresses appearing in the caption hereof for its product, Super RNA Complex (hereinafter sometimes called the product) (CX-1 through 10, 19, 20, 21; Tr. 7-30).
2. The product is furnished in capsule form in a container the label of which states that the ingredients of each capsule are:
RNA (ribonucleic Acid) 300 mg.
DNA (Deoxyribonucleic Acid) 50 mg.
Allantoin 7 mg.
Collagen 8 mg. in a base of Comfrey Root Powder (CX-15; Tr. 12).
Following are rules of interpretation of advertising applicable to proceedings under 39 U.S.C. § 3005 applied by the presiding Administrative Law Judge in this case to determine whether Respondent's advertisements for Super RNA Complex make the representations alleged in the Complaint:
"The meaning of advertising representations is to be judged from a consideration of an advertisement in its totality and the impression it would most probably create in ordinary minds. Donaldson v. Read Magazine, 333 U.S. 178 (1948); Vibra-Brush Corp. v. Schaffer, 152 F. Supp. 461 (S.D.N.Y., 1957); Borg-Johnson Electronics v. Christenberry, 169 F. Supp. 746 (S.D.N.Y., 1959). Express representations are not required. It is the net impression which the advertisement is likely to make upon purchasers to whom it is directed which is important, and even if an advertisement is so worded as not to make an express representation, if it is artfully designed to mislead those responding to it the mail fraud statutes are applicable. G. J. Howard v. Cassidy, 162 F. Supp. 568. See also Virginia State Board of Pharmacy v. Virginia Citizens Council, 425 U.S. 748 (1976)."
In Findings of Fact Nos. 3 through 8, below, the initial underscored sentence in each finding is a representation alleged in paragraph 3 of the Complaint to be made by Respondent.
3. Super RNA Complex retards the aging process.
Respondent's advertising matter is full of language making this representation. For instance, the following from CX-1:
"We took the world's best rejuvenator and made it even better."
"Super RNA Complex is most likely the world's most effective rejuvenator formulation."
"Super RNA Complex holds the most realistic promise of keeping you younger than anything developed before."
4. Super RNA Complex effectively replaces worn out and deteriorated human RNA.
This representation is found in the following language:
". . . the problem for RNA users and advocates alike has been how to get more working RNA as a replacement for worn out and deteriorated RNA into the cells to have a more dramatic anti-aging impact. But, now we have finally developed Super RNA Complex (etc.) . . ." (CX-1.)
5. Super RNA Complex is capable of altering the cell's genetic makeup.
Although Respondent's advertising makes dramatic claims concerning the effect of the product on human cells, I do not find that it goes so far as to represent to the ordinary mind that it will alter the cell's genetic makeup.
6. Exogenously administered RNA will effectively curb senility, restore vitality and sexual vigor, improve eyesight and hearing, and bring back a more youthful look to lined and wrinkled faces.
This representation is found in the following language:
"Doctors and scientists have reported using RNA supple-
ment to effectively curb senility, restore vitality and sexual vigor, improve eyesight and hearing, and bring back a more youthful look to lined and wrinkled faces. * * * now we have finally developed Super RNA Complex, a compound that utilizes the latest research and technology to attempt to provide the means to greatly increase the effectiveness, absorption, and anti-aging benefits of supplemental RNA." (CX-1.)
7. Large doses of supplemental RNA and DNA will increase the chances for absorption.
This representation is found in the following language as well as other places in Respondent's advertising:
"Super RNA . . . contains a bigger RNA dosage and adds DNA to increase the chance of entering the cells. .." (CX-3.)
8. Super RNA Complex contains ingredients that heighten the anti-aging effects of ribonucleic acid.
This representation is found in the following language as well as other places in Respondent's advertising:
"Super RNA Complex also contains a unique synergistic blend of collagen, allantoin and comfrey, to trigger and speed up the youthful rejuvenation process throughout the body." (CX-3.)
9. Complainant's witness Nancy J. Balter has a B.A. degree in Biology from Washington University, St. Louis, Missouri, and a Ph.D. in Pharmacology from Georgetown University (CX-17).
Pharmacology is the study of drugs, their interactions, and their effects on biological systems (Tr. 32). A therapeutic claim is a claim that a particular product will correct a situation where a deficit or an inability to correctly perform a function exists (Tr. 33).
Dr. Balter's education, training, and experience in the field of pharmacology qualifies her to evaluate the efficacy of products such as Super RNA Complex being offered for therapeutic benefits (Tr. 32).
In preparation for testifying in this matter, Dr. Balter conducted a research of the relevant literature using, among other sources, the Index Medicus (Tr. 35. Her research did not disclose reports of any scientifically valid studies that supplements of RNA and DNA produce any of the results claimed by Respondent in the representations alleged in the Complaint (Tr. 51).
Doctor Balter was qualified by education, experience and research to testify with respect to the claims made by Respondent for Super RNA Complex.
Doctor Balter's opinions on the matters in issue were based on a scientific viewpoint (Tr. 51) and are consistent with the informed scientific consensus (Tr. 44).
10. William Henry Saunders, M.D., a witness for Respondent, is licensed to practice medicine in the State of Georgia. He is in private practice, specializing in nutrition, exercise, and promotion of good health habits (Tr. 65, 66). There is no indication in the record that Dr. Saunders had done any research concerning RNA preparatory to testifying or that he has any special knowledge concerning RNA. He does not use supplemental RNA in his practice (Tr. 78). He does not in his practice specifically diagnose deficiencies in RNA (Tr. 77). He expressed guarded opinions as to the efficacy of RNA to provide some of the benefits promised in Respondent's advertising. His testimony reflects no special qualification by way of education, research, or experience to state such opinions.
11. Respondent's other witness, Richard Lord, has a B.S. degree (chemistry) from Georgia State University and a Ph.D. in bio-chemistry from the University of Texas at Austin. His experience includes one year as an NIH staff fellow at the National Institute of Arthritis and metabolic Diseases in Bethesda, Maryland.
He spent three years as president of Doctor's Data in Chicago working with a group of physicians in various specialized testing to determine nutritional status. He then established and operated for five years a laboratory in Atlanta doing clinical testing. He is presently a professor of chemistry at Life Chiropractic College in Marietta, Georgia. Doctor Lord's major field is nutritional biochemistry (Tr. 80-82).
12. Doctor Lord made no special research relative to RNA preparatory to testifying (Tr. 92) but he has studied as a matter of course the biochemistry of RNA and has tried to stay abreast of the literature relating to the effects of RNA on aging (Tr. 83). He stated that there is much evidence that RNA supplementation, such as Super RNA Complex, can have a beneficial effect on degenerative conditions such as aging, senility, eyesight and hearing problems, and wrinkling of the skin (Tr. 84-86).
Doctor Lord's only specific references to such evidence were the observations of Dr. Benjamin Frank, referred to in a review article in Geriatrics (October 1977) by Saul Kent, entitled "Can Nucleic Acid Therapy Reverse the Degenerative Process of Aging?" (RX-2; CX-18) and a 1961 article in Geriatrics entitled "Effects of Ribonucleic Acid on Memory."
13. Doctor Lord stated that RNA supplement would be most effective with old people who are on diets low in RNA and protein but that he really doesn't know who, and what proportion of the population, would benefit from RNA supplementation (Tr. 113, 114).
14. Doctor Lord agreed that the Kent article (RX-2, CX-18) cast doubt on the validity of Dr. Frank's findings. He agreed generally with the conclusion of the Kent article that "nucleic acid therapy is a clearly promising approach to treatment of aging and degenerative disease, but its value is as yet undetermined." (Tr. 90.)
15. Doctor Lord is a member of the advisory board of Respondent's magazine SOMA and has received a $200 fee therefor. He has consulted with Respondent on the bio-chemical rationale for formulating products (Tr. 111, 112).
16. RNA is ribonucleic acid. It is a micromolecule which transmits genetic information from DNA in the synthesis of proteins which carry on bodily cellular functions. RNA is synthesized by each cell of the body under the direction of DNA. There is no established need in human nutrition for supplemental RNA. There is no established pharmacological effect from oral ingestion of RNA supplement in capsule form (Tr. 37, 38).
17. Almost all food sources contain RNA and DNA which are broken down in the digestive process into nucleotides and nucleosides which are absorbed into the bloodstream and taken into the cells and used as building blocks in the synthesis of new DNA-directed RNA. There is no established need in human nutrition for supplemental nucleosides and nucleotides (Tr. 37, 38).
18. The source of the RNA in Respondent's product is probably yeast. Yeast RNA will code for protein of yeast and presumably has little, if any, effect on the human cell and cannot enter the human cell as RNA (Tr. 39, 40).
19. DNA is deoxyribonucleic acid, the material of which the genes are made and which codes for, or causes the synthesis of, RNA. It directs RNA to make the protein in which each cell needs. The body synthesizes its own DNA. There is no established need in human nutrition for supplemental DNA. There is no known pharmacologic effect of ingesting DNA supplement in capsule form. The digestive process works the same on DNA as on RNA. There is no evidence that supplemental DNA contributes to increased absorption of supplemental RNA (Tr. 40, 41).
20. There is no known beneficial effect on humans of exogenously administered allantoin or collagen (Tr. 41).
21. There are no reported valid, controlled clinical studies supporting Respondent's advertised claims for Super RNA Complex (Tr. 44).
22. The ingestion of Super RNA Complex will not provide any of the benefits promised in the representations made by Respondent for the product as alleged in the Complaint and found in Findings of Fact Nos. 3, 4, and 6 through 8, supra (Tr. 41-44).
1. 39 U.S.C. § 3005 has been held, repeatedly, by the courts to be constitutional under first and fourteenth amendment attack. Original Cosmetics Products, Inc. v. Strachan, 459 F. Supp. 496 (S.D. N.Y. 1979) aff'd Unpub. Op. (2d Cir. 1979); cert. denied 444 U.S. 915 (1979); Hollywood House International, Inc. v. Klassen, 508 F.2d 1276 (1974). The court in Original Cosmetics, supra, held that the recent U. S. Supreme Court decision in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976) does not require a contrary result.
2. Respondent argues that the postal false representation statutes violate one of the rights of privacy of the members of the public, specifically the right to pick and choose medical remedies not proven injurious to health. In support of this argument Respondent cites Doe v. Bolton, 410 U.S. 179 (1973). The instant case bears no resemblance to Doe, which involved the constitutionality of certain Georgia abortion statutes which imposed, so the Court held, certain conditions violative of the fourteenth amendment on the right of patients to receive medical care and the right of physicians to practice medicine. In a concurring opinion Justice Douglas said that the patient's right of privacy was violated by the conditions that a staff committee of the hospital approve the abortion procedures and that the judgment of the patient's physician be confirmed by two other physicians.
The postal statute does not interfere with the right of an individual to pick and choose medical remedies. He may purchase RNA-DNA supplements over-the-counter if he wishes. He may buy them through the mails if he wishes. The statute simply helps to protect the public from being duped by means of false representations concerning this product or any other sold through the mails. It is only Respondent's fault, the making of false representations, which should lead to inability of the public to purchase the product from Respondent. The statute does not interfere with the public's right to purchase this product or any other properly and honestly represented as to its efficacy.
3. I am deciding the falsity issues in this matter based on the testimony of Dr. Balter. The conformity of her opinions with the informed scientific consensus stands unrefuted by Respondent's evidence which, at best, might lead to the conclusion that future scientific investigations may disclose that this, or a similar, product is efficacious to produce one or more of the results represented by Respondent. The opinions of Respondent's experts and the reports of studies received in evidence fall far short of establishing such efficacy. Doctor Balter's testimony made a prima facie case for Complainant on the falsity issues not overcome by a preponderance of reliable and probative evidence on Respondent's part.
4. Respondent is engaged in a scheme or device to obtain money or property through the mails for its product, Super RNA Complex, by means of false representations substantially as characterized in the Complaint with the exception that no representation is made that the product is capable of altering the cell's genetic makeup. Such representations are material in that their natural tendency is to induce readers to purchase the product.
5. Respondent's scheme or device is in violation of 39 U.S.C. § 3005. Consequently, an order pursuant to that statute should be issued against Respondent.