In the Matter of the Complaint Againt

STANDARD RESEARCH LABS
Post Office Box 9547 at
Fort Lauderdale, FL 33310

P.S. Docket No. 7/76

Grant, Quentin E.

APPEARANCE FOR COMPLAINANT:
Thomas A. Ziebarth, Esq.
Consumer Protection Division,
Law Department
United States Postal Service
Washington, DC 20260

APPEARANCE FOR RESPONDENT:
Jack Paller, Esq.
Katz, Paller & Land,
470 East Paces Ferry Road, N.E.,
Atlanta, GA 30305

INITIAL DECISION

Complaiant filed a complaint on August 13, 1979, alleging that Respondent is in violation of 39 U.S.C. § 3005 by engaging in conducting a scheme or device for obtaining money or property through the mails by means of false representations made in articles, circulars and advertisements concerning its product, CALCIUM PANGAMATE (B[15]).

The specific allegations of false representations made by Respondent concerning the product appear in paragraph (3) of the Complaint as follows:

(a) CALCIUM PANGAMATE (B<15>) is a "universal remedy" effective in the prevention, alleviation, treatment or cure of such diseases or conditions as: $M02,19,20$D$Qheart disease$Bdrug addiction$Qsenility$Bschizophrenia$Qautism$Bhepatitis$Qangina pectoris$Bjaundice$Qsexual debilities$Ballergies$Qbreast cancer$Bdermatitis$Qalcoholism$Bmild poisoning$Qcirrhosis$Bneuralgia$Qdiabetes$Bsciatica$Qgangrene$Bneuritis$Qhypertension$Bminimum damage$Qglaucoma$Bbrain dysfunction.$X

(b) CALCIUM PANGAMATE (B<15>) will retard the aging process;

(c) CALCIUM PANGAMATE (B<15>) will neutralize and clear the blood of pollutants thereby increasing oxygen levels in the blood;

(d) CALCIUM PANGAMATE (B<15>) will maintain cellular health by increasing the efficiency of cellular respiration;

(e) CALCIUM PANGAMATE (B<15>) is a source of energy;

(f) CALCIUM PANGAMATE (B<15>) is effective in reducing the pain and discomfort caused by heart problems;

(g) CALCIUM PANGAMATE (B<15>) will normalize cholesterol levels and keep the arteries free from fatty deposits;

(h) CALCIUM PANGAMATE (B<15>) will fight fatigue by decreasing the build-up of lactic acid;

(i) CALCIUM PANGAMATE (B<15>) can prevent and cure heart disease; and

(j) The product furnished in response to its advertisements is CALCIUM PANGAMATE.

Respondent filed an answer denying the allegations of falsity and denying that certain of the printed matter attached as exhibits to the complaint are advertisements for Respondent's product, CALCIUM PANGAMATE (B<15>).

A hearing in the matter, originally scheduled for September 11, 1979, was held in Miami, Florida, on October 12, 1979. Following numerous continuances and extensions of time requested by one or the other, or both of the parties, the case stands ready for decision as of January 5, 1980 with the filing of Complainant's proposed findings of fact and conclusions of law.

All of the proposed findings of fact, conclusions of law and arguments of the parties having been considered, they are adopted to the extent indicated and are otherwise rejected as unsupported by or contrary to the evidence or because they are irrelevant or immaterial.

FINDINGS OF FACT

1. Respondent's advertisements and promotional materials solicit the remittance of money through the mails for CALCIUM PANGAMATE (B<15>) the product involved in this proceeding (CX-1 through CX-5; Answer, parag. 2; Stipulation, Tr. 304, 305).

2. The advertisements and articles on which the Complaint is based appeared in a magazine called Body Forum, a publication separate and distinct from Respondent (Stipulation, Tr 305). The article included in each of Complainant's exhibits 1 through 4 appeared in the same issue of Body Forum as the advertisements and order form contained in the particular exhibit (Stipulation, Tr. 304). One of Complainant's exhibits (CX-5b) is a reprint of an article from New York Magazine entitled "Will Vitamin B<15> Cure What Ails You". This repringt, along with an order form for B<15> (CX-5a) was included as an insert to a package containing another of Respondent's products, Formula - 12. Respondent admits that it mails the reprint directly to consumers (Resp. Proposed F of F no. 2).

3. Except for the allegation that Respondent's advertising represents that CALCIUM PANGAMATE (B[15]) is effective in preventing, alleviating, treating or curing breast cancer, sexual debilities and angina pectoris which Complainant has not established in proof and argume, I find that Respondent's advertising materials (without resort to accompanying articles or editorial comment in the Body Forum magazine) make the representations alleged in paragraph (3) of the Complaint in the wording quoted below following each quoted alleged representation:

(a) CALCIUM PANGAMATE (B<15>) is a "universal remedy" effective in the prevention, alleviation, treatment or cure of such diseases or conditions as: heart disease * * * alcoholism, cirrhosis, diabetes, gangrene, hypertension, glaucoma, * * * senility, autism, drug addiction, schizophrenia, jaundice, hepatitis, allergies, dermatitis, mild poisoning, neuralgia, sciatica, neuritis, [and] minimum damage brain dysfunction.

B<15>, a famous Soviet doctor and medical researcher has referred to it as a "universal remedy."

Miraculous results follow]

(CX-1)

B<15>, A Universal Remedy.

(CX-2, p. 3)

Long touted as a universal remedy by medical researchers throughout the world.

(CX-3, p. 4)

The Russians are experimenting with B<15> as an agent in the prevention of breast cancer.

(CX-1)

B<15> AS THE RUSSIANS SEE IT

This is a list of the areas in which B<15> is effective, according to Russian research. $M02,30,25$D$G*2*FUNCTIONS OF B<15>$Q$QExtends cell life span$BDetoxifies pollutants$Q$QImproves blood oxygenation$BInvolved in protein$Q$Bsynthesis$Q$QStimulates immune response$BLiver protecting$Q$QInvolved in energy transport$BSpeeds recovery from$Q$Bfatigue$Q$Q$BRegulates blood levels$Q$Bof steroids$X $M03,16,16,16$D$G*3*DISEASES TREATED BY B<15>$QHeart diseases$BAlcoholism$BAllergies$QAging$BDrug addiction$BDermatitis$QSenility$BAutism$BMild poisoning$QDiabetes$BSchizophrenia$BNeuralgia$QGangrene$BCirrhosis$BSciatica$QHypertension$BHepatitis$BNeuritis$QGlaucoma$BJaundice$X

Minimum damage brain dysfunction.

(CX-5b)

(b) CALCIUM PANGAMATE (B<15>) will retard the aging process.

The Fountain of Youth that Comes in a Bottle] (headline)

The result: older men and women feel young again.

And speaking of old age. B<15> is a nutritional fountain of youth ... B<15> slows down the aging process.

(CX-1)

The Fountain of Youth that Comes in a Bottle] (headline)

How B<15> Reverses Aging.

(CX-2, p. 3)

B<15> Because you deserve to stay young as long as possible. (headline)

. . . may be the key to staying young.

. . . can help reverse aging . . .

If the look and vitality of youth are important to you, order a supply of B<15> now.

(CX-4, p. 2)

(c) CALCIUM PANGAMATE (B<15> will neutralize and clear the blood of pollutants thereby increasing oxygen levels in the blood.

B<15> increases the oxygen level in the blood and tissues. . . . For example, bodily pollutants in the blood which destroy oxygen in the cells and thereby produce fatigue and disease are rendered harmless.

(CX-1)

. . . helps the body to maintain high levels of oxygen for the cells' use.

(CX-2, p. 3)

B<15> cleans the blood of pollutants. . . . It neutralizes these pollutants, thus the circulating blood has more oxygen for the cells to use in creating energy.

(CX-3, p. 4)

. . . can help reverse aging by promoting normal oxygenation of the cells.

(CX-4, p. 2)

(d) CALCIUM PANGAMATE (B<15>) will maintain cellular health by increasing the efficiency of cellular respiration.

. . . Simply by consistently prompting [sic] normal oxygenation in the cells.

. . . to maintain high levels of oxygen for the cells' use.

(CX-2, p. 3)

B[15] can keep you younger because of its amazing ability to increase the efficiency of cellular respiration.

(CX-3, p. 4)

(e) CALCIUM PANGAMATE (B<15>) is a source of energy

B<15> Gives You the Energy of Youth . . . upsurge is energy and stamina.

(CX-2, p. 3)

B<15> gives you the stamina to keep going strong all day.

(CX-3, p. 4)

Many B<15> users report increased energy and stamina.

(CX-4, p. 2)

(f) CALCIUM PANGAMATE (B<15>) is effective in reducing the pain and discomfort caused by heart problems.

Heavy breathing and pain tend to disappear; the discomfort for angina is also remedied.

(CX-3, p. 1)

Others use B<15> under a doctor's supervision, as a part of therapy to relieve the pain and discomfort of heart problems.

(CX-3, p. 4)

(g) CALCIUM PANGAMATE (B<15>) will normalize cholesterol levels and keep the arteries free from fatty deposits.

B<15> has been shown to normalize cholesterol levels and keep the arteries free from fatty deposits

(CX-1)

. . . and has been shown to help normalize blood cholesterol levels and to help keep the arteries free from fatty deposits.

(CX-2, p. 3)

(h) CALCIUM PANGAMATE (B<15>) will fight fatigue by decreasing the build-up of lactic acid.

. . . they showed a decrease in the build-up of lactic acid, the cause of muscle fatigue . . . We all take B<15>.

(CX-1)

(i) CALCIUM PANGAMATE (B<15>) can prevent and cure heart disease.

(j) The product furnished in response to its advertisements is CALCIUM PANGAMATE.

Each of Respondent's advertisements (CX-1; CX-2, p. 3; CX-3, p. 4; and CX-4, p. 2) show a picture of the product which is labeled, "B15 Calcium Pangamate."

4. The product, marketed as "B<15>" and "CALCIUM PANGAMATE," is a mixture of two active ingredients: calcium gluconate and dimethyl glycine. Many of the products purporting to be calcium pangamate or pangamic acid sold commercially in the United States contain or consist of that mixture (Tr. 308).

5. George Christakis, a doctor of medicine with special qualifications in pharmacology, nutrition, internal medicine, epidemiology, and public health testified for Complainant (CX-6; Tr. 311, 312). According to Dr. Christakis, calcium pangamate and pangamic acid are distinct entities but often used synonymously in the literature. He expected that the pharmacologic action of each could generally be the same (Tr. 313, 314). In Dr. Christakis' search of the literature for materials describing or identifying the substance called calcium pangamate, he encountered the problem that it does not have a standard of identity; it was, in fact, many things in different articles. Besides the mixture of calcium gluconate and dimethyl glycine, making up Respondent's product, compounds called dichloroacetate and di-isopropylamine have been sold or marketed as calcium pangamate. In one reference found by Dr. Christakis (Stacpoole article in World Review of Nutrition Dietetics, 1977) pangamic acid is referred to chemically as dimethylaminoacetal gluconate acid (Tr. 314). There is no consensus as to the chemical composition of calcium pangamate or pangamic acid (Tr. 314, 315).

6. References to pangamic acid and calcium pangamate as B[15], giving it the semblance or connotation of a legitimate vitamin, is misleading because there is no vitamin officially designated as B[15] (Tr. 316).

7. Calcium gluconate is used in medicine primarily for treating rare cases of hypocalcemia, a condition involving low level of calcium in the blood. For that purpose it is used in large doses, usually up to 1000 mg. This is the only bona fide medical use of calcium gluconate (Tr. 317). Dimethyl glycine is one of thousands of compounds, consumed daily, having two methyl groups which act as methyl donors. There is nothing unique about it. It has no special physiological or pharmacological properties (Tr. 317, 318).

8. According to Dr. Christakis, there is no evidence that the ingredients of Respondent's product, individually or in combination, are or would be efficacious in preventing, alleviating, treating, or curing any of the diseases or conditions enumerated in the complaint (Tr. 330, 331, 333). Dr. Christakis' opinion conforms to the informed medical consensus.

9. Respondent did not present a medical or other expert at the hearing. But with Complainant's agreement Respondent was allowed to file in this proceeding the affidavit of one Allan Cott, a medical doctor who has practiced psychiatry for 40 years but presently considers himself a clinical nutritionist using nutrition "as part of my armamentarium in the study and treatment of psychophysiological conditions". Based on his educational background, extensive current reading in American and Russian medical literature and his medical practice, Dr. Cott expresses the belief that "B.15 (Pangamic Acid) does in fact produce positive psychological and physical effects." Dr. Cott refers to a number of Russian studies and experiments which he says establish (1) the nontoxicity of B15; (2) that it contributes to a high level of energy for muscle contraction, nerve conductivity, and membrane permeability; (3) that it had a "positive effect" on 80-90 percent of 1000 patients suffering from cardiovascular diseases; (4) that the physiological role of pangamic acid in the organism is based on its lipotropic activity, its stimulation of oxidative metabolism in cell tissues, and on its detoxifying activity; that it can cause a decrease in the content of ascorbic acid and cholesterol in the blood; that B15 is effective in improving the speech of retarded children. Based on the Russian literature and on his personal experience in use of B15 on patients, Dr. Cott expresses the belief that it is a "benefit for the treatment of asthma and other allergic conditions".

10. Dr. Allan Cott's affidavit states that the B15 which he uses, consisting of calcium gluconate and N-dimethylglycine as calcium pangamate, is the pharmacological equivalent of the substance referred to in the Russian literature and that Respondent's product contains the same ingredients.

11. Based on the Russian experimental literature and his own practical clinical experience, Dr. Cott states the following conclusions:

"a) B-15 increases the supply of oxygen in the blood and its uptake into the body's tissues through transmethylation, such that it corrects or reverses hypaxia, as B-15 stimulates the hypothysis of the supra-renal glands.

b) That B-15 along with enhanced oxygenation at the cellular level is lipotropic in character and hence produces protection of the liver and with detoxification of the blood from the effects of alcohol and drugs.

c) That B-15 lowers blood lactic acid and cholesterol levels, normalizing blood sugar metabolism and reducing the effect of fatigue."

Dr. Cott states that pangamic acid is a vitamin "because it is almost impossible to escape the self-limiting mechanisms that prevent any toxic manifestations."

12. In an affidavit filed by Complainant in response to that of Dr. Cott, Dr. Christakis states:

"a) that nutrition journals recognized by professional nutrition associations have not recognized the existence of a vitamin called B15;

b) that the current Merck Index will not recognize the existence of B15;

c) that Dr. Cott's anecdotal comments on the Russian research and clinical experience regarding pangamic acid does not provide a valid basis for assessing the scientific authenticity of such research and experience;

d) that the following classical criteria of a vitamin have not been exhibited in connection with pangamic acid:

1. a deficiency disease has not been identified as caused by the absence of the substance

2. the substance has not been proved essential for the maintenance of normal metabolic functions

3. it is not known whether the body is incapable of synthesizing it.

13. Dr. Christakis concludes in his affidavit that the evidence cited by Dr. Cott to support the physiological effects attributed to pangamic acid is unsubstantiated, has not met the standards of critical peer review and, therefore, does not meet the criteria for scientifically-based truth.

14. Dr. Christakis states that his opinion on the matters in issue conform to the informed medical consensus. Dr. Cott's affidavit does not make that assertion.

15. Based on the opinion expressed by Dr. Christakis I find that Respondent's product, CALCIUM PANGAMATE (B15), is not effective as a means of producing the results claimed by the representations found above. Such representations are false in fact, and materially so in that they are obvious inducements to purchase the product.

16. Respondent has not proved that the product is not one of the forms of calcium pangamate.

CONCLUSIONS OF LAW

1. "Body Forum" magazine is an entity distinct from Respondent. Complainant has not shown that Respondent's advertisements in that publication appeared in close proximity to the editorial or article content relating to B15, or, it they did, that Respondent had any responsibility for such location. Therefore, I do not find sufficient basis to hold that statements in such editorial or article matter concerning the efficacy of B15 constitute representations made by Respondent. The cases cited by Complainant in this connection are factually distinguishable and, therefore, not precedent for holding to the contrary (Farley v. Simmons, 99 F.2d 343 (D.C. Cir., 1938; P.O. Box 239, P.S. Docket No. 1/49 (1972); Good Drugs, P.S. Docket No. 1/93 (1974)).

2. The article reprint (CX-5b) was obviously sent directly to customers by Respondent for the purpose of inducing readers thereof to order B15. It would not be reasonable to believe it was distributed by Respondent for any other purpose. Although careful reading of the article discloses some doubts expressed as to the "cure-all" claims made bor B15 by the Russians, the over-all tenor of the article touts B-15 as effective in the areas listed at the end of the article. It is reasonable to think that Respondent would not have distributed the article had it not believed the article would promote sales of the product.

3. 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, it if it 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 Consumer Council, 425 U.S. 748 (1976).

"Advertisements as a whole may be completely misleading although every sentence separately considered is literally true. This may be because things are omitted that should be said, or because advertisements are composed or purposefully printed in such way as to mislead." Donaldson v. Read Magazine, supra, p. 188.

4. Applying the foregoing tests to the Respondent's advertisements and the article reprint (CX-5b) I concluded that they make representations as alleged in the complaint with the exceptions noted in Finding of Fact No. 3, supra.

5. Complainant has established the falsity of these representations except as to subparagraph j of paragraph 3 of the complaint, by a preponderance of the reliable, probative and persuasive evidence of record. Dr. Christakis' opinions stand unrefuted as being in conformity with the informed medical consensus. Dr. Cott did not purport to express a contrary consensus, although he was obviously enthusiastic about the long range potential for the general acceptance of B15 by the medical community. Dr. Cott's anecdotal references to Russian literature and experience, much of it many years old and apparently not validated by reported recent studies, do not furnish persuasive support for the broad and numerous claims made in Respondent's representations. Neither do Dr. Cott's vague descriptions of results obtained by him using B15 in his private practice and the conclusions he expressed as to the physiological activities of B15. Dr. Christakis' statements in testimony that knowledge of pangamic acid is incomplete at this time and that "we are at the stage of not even agreeing on what it does' do not attenuate his own opinions as expressing the informed medical concensus. Lack of complete knowledge and existence of disagreement do not prevent a consensus.

6. It has been held repeatedly that expert opinion testimony need not be based on tests of the particular product to constitute sufficient evidence of false advertising representations. Pinkus v. Reilly, 338 U.S. 269; Original Cosmetics Products Inc. v. Strachan, 459 F. Supp. 496 (1978), aff'd 2d Cir. No. 78-6165, 4/30/79; Skinny Suit, P.S. Docket No. 3/44 (P.S. Decision, 2/19/76).

7. The representations made by Respondent concerning the product are materially false as a matter of fact.

8. Respondent is engaged in the conduct of a scheme for obtaining remittances of money through the mails by means of materially false representations in violation of 39 U.S.C. § 3005.

9. An order pursuant to 39 U.S.C. § 3005 in the form attached should be issued against Respondent.