In the Matter of the Complaints Against

 HOUSE OF QUALITY HERBS, INC.,
 Woodland Hills, California 91365
 Post Office Box 14 at

 P.S. Docket No. 6/132; P.S. Docket No. 6/133;
 P.S. Docket No. 6/134; P.S. Docket No. 6/135;
 P.S. Docket No. 6/136; P.S. Docket No. 6/137;
 P.S. Docket No. 6/138; P.S. Docket No. 6/139. 
 
 December 22, 1978

 Quentin E. Grant Administrative Law Judge
 
 Appearance for Complainant:
 Thomas A. Ziebarth, Esq.
 Consumer Protection Office
 Law Department U. S. Postal Service
 Washington, D.C.  20260 

 Appearance for Respondent:
 Paul J. Hedlund, Esq.
 6535 Wilshire Boulevard
 Los Angeles, California 90048

In complaints filed on August 11, 1978, complainant charged respondent with engaging in the conduct of schemes or devices to obtain money or property through the mails by means of false representations in violation of 39 U.S.C. 3005.

Nine different products are involved in these proceedings. In the numerical order of the docket numbers the products are called BIO-THERAPIN V (6/132), BIO-THERAPIN VII (6/133), BIO-THERAPIN III (6/134), BIO-THERAPIN II (6/135), BIO-THERAPIN I (6/136), SOLUTION II (6/137), GINSENG HERBAL REJUVENATING CREME (6/138), and CAPSICUM (6/139).

Following are the misrepresentations alleged in the complaints to be made in respondent's advertisements concerning each of the products:

(a) BIO-THERAPIN V is effective in the prevention, treatment, alleviation or cure of hair loss; and

(b) BIO-THERAPIN V will reverse the balding process by "awaken[ing] dormant hair follicles to an active growing stage."

(a) BIO-THERAPIN VII is effective in the treatment or alleviation of the "blotchiness of signs of varicose veins";

(b) BIO-THERAPIN VII will help "tone the veins on the surface of the skin while naturally stimulating and regulating skin circulation;" and

(c) BIO-THERAPIN VII will "normalize" skin circulation thereby causing skin blotches to become less apparent.

(a) BIO-THERAPIN III is effective in the prevention, treatment, alleviation or cure of acne; and

(b) BIO-THERAPIN III has a natural astringent and anti-inflammatory action which will slow down the secretion of excess oil thereby allowing the skin pores to remain free and open.

(a) BIO-THERAPIN II is effective in the treatment or alleviation of facial wrinkles, and

(b) BIO-THERAPIN II will penetrate the skin and restore the fibre elasticity of the skin.

(a) BIO-THERAPIN I is effective in the treatment, alleviation or cure of "stretch marks";

(b) Continued use of BIO-THERAPIN I may shrink "stretch marks"; and

(c) Prolonged use of BIO-THERAPIN I may help eliminate all visible signs of "stretch marks."

(a) SOLUTION II is an effective aid in the alleviation or treatment of facial or genital cold sores and other very stubborn skin conditions; and

(b) SOLUTION II may be safely used in treating genital viral infections (viz., "cold sores" in the genital areas).

(a) The "exclusive combination of Korean Ginseng, natural herbs and vitamins" contained in GINSENG HERBAL REJUVENATING CREME will nourish and normalize the skin; and

(b) The "exclusive combination of Korean Ginseng, natural herbs and vitamins" contained in GINSENG HERBAL REJUVENATING CREME will combat the main cause of wrinkling.

(a) CAPSICUM is effective in the prevention, alleviation, treatment or cure of colds; and

(b) CAPSICUM will improve circulation throughout the body.

Each complaint also contains an allegation that the misrepresentations alleged therein are materially false as a matter of fact.

At respondent's request the location of the hearing was changed from Washington, D.C. to Los Angeles, California, and was continued from September 11 to October 3, 1978.

Following a consolidated hearing in the eight cases, and extensions of time requested by the parties, complainant has filed proposed findings of fact and conclusions of law. Respondent's time to file such findings and conclusions was extended to November 13, 1978, but to date they have not been filed.

1. The copies of the advertisements annexed to each of the complaints are true copies of advertisements, order blanks, and envelopes used by respondent and each of such advertisements is found in respondent's catalog entitled "Herbs for Health and Happiness No. 3" (Stip. No. 1).

2. Respondent seeks remittances of money through the mail by means of such advertisements, order blanks, and envelopes (Stip. No. 2).

3. The content of the label on each product involved in these proceedings is accurately set forth in CX-2 (Stip. No. 3).

4. Jack L. Segal, M.D., who testified for complainant, is board certified in internal medicine and has had extensive experience in the field of clinical pharmacology, which he defined as the study of the effects of medications and drugs on humans (CX-5; Tr. 19, 20). Dr. Segal has also had extensive training and experience in the field of pharmacognosy, defined as the study of natural substances or substances derived from plant and animal sources including herbs that may have medicinal value (Tr. 21-26). Based on his training and experience Dr. Segal was well-qualified to testify as to the products involved in these proceedings.

5. Melvin Pressman, a registered pharmacist in the State of California who has practiced pharmacy for 13 years, testified for respondent. In addition Mr. Pressman testified that he is also primarily a nutritionist dealing in vitamins for horses and small animals. Mr. Pressman is familiar with texts in the fields of pharmacology and pharmacognosy and has studied herbs to some extent in a course on the subject of materia medica . Mr. Pressman was minimally qualified to testify in these matters.

6. Based on Stipulation Nos. 1 and 2 filed herein, as well as complainant's exhibits CX-1 through CX-4, I find that respondent in each of these matters is engaged in a scheme or device to obtain money or property through the mails for the particular product involved.

1. I find that respondent's advertising in the wording quoted in paragraph (3) of the complaint makes the representations that BIO-THERAPIN V is effective in the treatment, cure, or alleviation of hair loss and will reverse the balding process by "awaken[ing] dormant hair follicles to an active growing stage."

2. Dr. Segal, testifying for complainant, stated that in the normal human, particularly, the male, there exists a genetically determined pattern of baldness which occurs in nearly all males and a small percentage of women to a greater or lesser degree.

Such baldness occurs as part of the aging process and is not amenable to change by any known therapeutic intervention, either topical or systemic. There are other types of baldness, some associated with metabolic processes, infectious processes, fungi or bacteria, none of which, according to Dr. Segal, would be modified, ameliorated, or changed by the constituents of the product (Tr. 27).

3. According to Dr. Segal none of the ingredients of BIO-THERAPIN V with the exception of Vitamin F (pre-fatty acids), a part of the circulative lipids in the human blood, is pharmacologically active in normal human beings or has medicinal or therapeutic value. In Dr. Segal's opinion none of the constituents of BIO-THERAPIN V will modify, ameliorate or change a condition of baldness (Tr. 27).

4. Two of the ingredients, arnica and rosemary are rubafacients or astringents which cause an increase in the blood flow in the area to which they are applied but, according to Dr. Segal, increase of blood flow in the scalp has not been shown to be efficacious in treatment of hair loss (Tr. 40, 41).

5. Respondent's witness, Pressman, acknowledged that BIO-THERAPIN V would have no effect on male pattern baldness or hereditary baldness (Tr. 165).

6. Based on the testimony of Dr. Segal, I find that respondent's representations concerning BIO-THERAPIN V as alleged in the complaint are false in fact.

1. I find that respondent's advertising in the wording quoted in paragraph (3) of the complaint makes the representations alleged therein as to the product BIO-THERAPIN VII.

2. Dr. Segal testified that a varicose vein is a subcutaneous vein the wall of which lost its integrity, the path thereof having become tortuous or irregular; that the major cutaneous manifestation of severe varicosity is a stasis dermatitis associated with poor nutrition to the skin, not a blotchiness (Tr. 60, 61). Medical treatment of varicose veins includes pressure in the form of support hose, surgical excision, or injection of sclerosing solutions. According to Dr. Segal there is no known medical substance which when applied topically will alleviate the condition (Tr. 50).

3. In Dr. Segal's opinion, none of the ingredients of BIO-THERAPIN VII individually or in combination are efficacious in treating blotchiness of varicose veins (Tr. 49). At most, the product might have some emollient effect on the skin (Tr. 49).

4. According to Dr. Segal the words "tone the veins on the surface of the skin while naturally stimulating and regulating skin circulation" as used in respondent's advertisements has no medical meaning.

5. Mr. Pressman, respondent's witness, was of the opinion that the presence of ergotamine, an ergot derivative, in St. John's Wort, one of the ingredients of the product, would cause decolorization by increasing blood circulation in blotchy areas of the skin and would remove or tend to cause a change in the discoloration associated with the venules (Tr. 161, 162), the small capillary blood vessels near the surface of the skin (Tr. 59).

6. Dr. Segal agreed that the application of arnica, an irritant and one of the ingredients of the product, could modify local cutaneous circulation and might thereby change the coloration of an area of blotchiness to which it was applied (50-54).

7. I find that complainant has not proved by a preponderance of the evidence the falsity of the representation concerning BIO-THERAPIN VII alleged in the complaint.

1. I find that respondent's advertising in the following wording contained therein makes representations as to the product, BIO-THERAPIN III, substantially as characterized in the complaint.

"An Aid in the Treatment of Acne***"

"Used as directed, it***diminishes the proclivity for acne"

"***this preparation has a natural astringent and anti-inflammatory action [which] slows down the secretion of excess oil allowing the skin pores to remain free and open***"

2. Dr. Segal testified that the specific cause or causes of acne have not been determined (Tr. 63); that the treatment for acne varies, being directed primarily toward increased personal hygiene, dietary modification and removal of offending foreign matter which may cause local irritation; that in some cases antibiotics are used; but that by and large the therapy is non-specific and has to be individualized.

3. Dr. Segal testified that an astringent would restrict the openings of the skin pores and perhaps predispose them to accretion of excess oils and secretions, one of the major manifestations of acne (Tr. 64). He testified that extract of lemon, one of the ingredients of the product, probably has astringent qualities. He was of the opinion that allantoin, another ingredient, is primarily a moisturizer rather than an astringent (Tr. 65, 66).

4. In Dr. Segal's opinion, the ingredients of BIO-THERAPIN III, individually, or in combination, would not be effective in the treatment, prevention, alleviation, or cure of acne (Tr. 63). He was, further, of the opinion that the representation concerning the astringent action of the product is contradictory because an astringent would restrict the openings of the pores, thus aggravating the problem of excess oils and secretions associated with acne (Tr. 64).

5. Mr. Pressman, testifying for respondent, stated that there is some Vitamin A in the extract of watercress contained in the product and that Vitamin A in combination with Vitamin B is used by dermatologists in the treatment of acne. Pressman also stated that acne can also be corrected through the use of an astringent type substance such as allantoin (Tr. 158-160).

6. Based on the superior qualifications of Dr. Segal and his opinions as to the efficacy of BIO-THERAPIN III, I find that respondent's representations concerning the product as alleged in the complaint are false in fact.

1. I find that respondent's advertising in the following wording contained therein makes representations as to the product, BIO-THERAPIN II, substantially as characterized in the complaint:

"An Aid in the Treatment of Facial Wrinkles"

"The active ingredients in Bio-Therapin II penetrate the skin to aid the natural restoration of fibre elasticity."

2. Dr. Segal testified that facial wrinkling is part of the aging process, caused by the loss of the elastic properties of the tissue and loss of the integrity of the connective material between the tissues and that plastic surgery is the only cure for such wrinkling (Tr. 70).

3. Dr. Segal testified that there is no medical preparation which taken topically or internally can alter or cure the loss of elasticity in facial tissue and, specifically, that there is nothing in BIO-THERAPIN II, taken individually or in combination, which would be effective in the treatment or alleviation of facial wrinkles or which would penetrate the skin and restore its elasticity (Tr. 70, 71).

4. Dr. Segal testified that some oils might temporarily moisturize the skin and temporarily smooth it over but would have no permanent effect or alleviating effect on the wrinkling process itself (Tr. 21).

5. Mr. Pressman testified that the vitamin content of the product would have an effect on the cutaneous tissue but did not specify what effect (Tr. 140, 155).

6. Based on the superior qualifications of Dr. Segal and his opinions as to the efficacy of BIO-THERAPIN II, I find that respondent's representations concerning the product as alleged in the complaint are false in fact.

1. I find that respondent's advertising in the following wording contained therein makes representations as to the product, BIO-THERAPIN I, substantially as characterized in the complaint.

"An Aid in the Treatment of Stretch Marks"

"Continued use might shrink the marks to thin lines resembling thread"

"In some cases, prolonged use may help eliminate all visible signs of stretch marks"

2. Dr. Segal defined a stretch mark as the loss of integrity of the elastic components or the ground substances of the skin. The visual manifestation of a stretch mark is a scar-like area in which the superficial structure appears to have pulled apart and left areas where the skin has a different texture or a different color (Tr. 84).

3. The only definitive treatment for stretch marks is surgical revision or excision (Tr. 84). There is no medical means, either topically applied or systemically taken, which will modify or remove stretch marks (Tr. 84, 85).

4. Mr. Pressman testified that extract of ivy, one of the ingredients of the product, would cause shrinking of the skin as a result of its astringent action and a "possible deletion of the scar or stretch mark" (Tr. 152, 153).

5. Based on the superior qualifications of Dr. Segal and his opinions as to the efficacy of BIO-THERAPIN I, I find that respondent's representations concerning the product as alleged in the complaint, are false in fact.

1. I find that respondent's advertisements in the following wording contained therein make representations as to the product, SOLUTION II, substantially as characterized in the complaint.

"Many thousands of people all over the world are contacting painful and embarrassing facial or genital cold sores***. Now Solution II is an effective aid in treating these conditions. And it also seems to help in other very stubborn skin conditions. The results are amazing."

2. According to Dr. Segal a cold sore is an ulcerating type of lesion usually appearing on the oral mucosa or the lips in association with an upper respiratory infection or a cold. A genital "cold sore" is similar but probably caused by a different strain of the Herpes virus (Tr. 92, 93).

3. There is no single therapy for these sores. There are a number of drugs, none of which are ingredients of SOLUTION II (Tr. 96), being evaluated for use in treating them and there are clinics, such as the one at UCLA, devoted to treatment of the problem. It does not respond to any known anti-biotic (Tr. 93, 94).

4. None of the ingredients of SOLUTION II, taken individually or in combination, would tend to alleviate, treat, or cure facial or genital cold sores (Tr. 94).

5. Use of the product in connection with genital "cold sores" might be harmful in that it would deny the user the possibility of obtaining some alleviation of the symptoms through whatever therapies are available (Tr. 94).

6. Mr. Pressman, testifying for respondent, stated that ancient people as far back as 5000 or 6000 B.C. and Indians in this country utilized seaweed, containing some of the substances found in SOLUTION II, in treating ulcerating or lesion type ulcers (Tr. 151), but acknowledged lack of expertise in the area of sores caused by Herpes virus infections such as the sores involved in this case (Tr. 151, 152).

7. Based on the opinions of Dr. Segal, I find that respondent's representations concerning SOLUTION II as alleged in the complaint are false in fact.

1. I find that respondent's advertisement in the following wording contained therein makes representations as to the product, GINSENG HERBAL REJUVENATING CREME, substantially as characterized in the complaint:

"An exclusive combination of high grade Korean Ginseng. Natural Herbs and Vitamins designed to nourish and normalize your skin***will keep your skin naturally beautiful longer***a nourishing treatment at night***"

"Try this wonderful formula. Combat the main cause of wrinkling."

2. Dr. Segal testified that facial wrinkling is part of the aging process, caused by the loss of the elastic properties of the tissue and a loss of integrity of the connective material between the tissues and that plastic surgery is the only cure for such wrinkling (Tr. 101 stipulation; Tr. 70).

3. Dr. Segal testified that there is no medical preparation which taken topically or internally can alter or cure the loss of elasticity in facial tissue (Tr. 70).

4. Dr. Segal testified that there is nothing in the product which taken individually or in combination will nourish or normalize the skin or that will combat the main cause of wrinkling (Tr. 101).

5. Dr. Segal testified that the product is an emollient, a soothing creme that may have some moisturizing properties which might temporarily minimize the appearance of minor facial wrinkles or lines but that it would not permanently reduce the appearance of wrinkling or eliminate or interfere with the ongoing process of wrinkling once it has been established (Tr. 101, 102).

6. Dr. Segal testified that the word "normalize" as applied to skin has no medical significance. He indicated, however, that as a lay term it might refer to protecting the skin or to alleviating an abnormal condition such as mild abrasions or burns and that the product does contain some ingredients which may protect the skin and relieve the pain and discomfort of burned or abraded areas (Tr. 105, 106).

7. Mr. Pressman, testifying for respondent, stated he understands the term "normalize" to mean returning something to its original state and that the ingredient of the product called allantoin will normalize the skin. Pressman was of the opinion that use of the product by the undersigned would "hopefully" return his skin to its condition of 25 or 30 years ago (Tr. 144). Pressman testified further that the emollient qualities and vitamin content of the product will nourish the skin, that the astringent properties of the ingredient aloe vera will tighten the skin causing it to look younger (Tr. 140, 141), and that the ingredient allantoin will increase the blood circulation in the skin (Tr. 141, 142).

8. Pressman disclaimed having knowledge as to whether use of the product will have a permanent effect on the aging process (Tr. 145). He stated that as an emollient the product has only temporary effect (Tr. 145, 146).

9. The testimony of Dr. Segal and Dr. Pressman indicates that the product may have some temporary nourishing and normalizing effects on the skin. Therefore, I find that complainant has failed to prove the falsity of the representation that the product will nourish and normalize the skin.

10. Based on Dr. Segal's opinion, I find that the product will not combat the main cause of wrinkling and, therefore, I find that such representation is false in fact.

1. I find that respondent's advertisement in the following wording contained therein makes representations as to the product, CAPSICUM, substantially as characterized in the complaint.

"Combat colds with Capsicum. To keep resistance high, the Vitamin C content in Capsicum is Nature's best source***this herb aids in producing warmth and improved circulation throughout the body***.

2. According to Dr. Segal the word "Capsicum" is a generic term covering peppers in general (Tr. 110). Taken as directed (1 or 2 tablets a day) it contains probably less than 1 or 2 mgs. of Vitamin C as against the 30-50 mg. recommended daily allowance for adults and as against the megadosage of 300 to 500 mg. per day recommended by Dr. Linus Pauling for the treatment or alleviation of colds (Tr. 110, 113-115, 125-127).

3. Dr. Segal testified that capsicum is very poorly absorbed in the gastro-intestinal tract, thus working against any systemic effects, particularly those involving the blood vessels (Tr. 119).

4. Dr. Segal testified that there is no known effective cure or treatment for colds. In his opinion, the product CAPSICUM is of no value in the treatment, alleviation, or cure of the common cold and will not improve circulation throughout the body (Tr. 109).

5. Mr. Pressman, reading from Remington's Practice of Pharmacy (11th Ed.), stated that capsicum is used internally as a gastric and intestinal carminative and externally as a rubafacient. A carminative is an aid to digestion, according to Dr. Segal and Mr. Pressman. Pressman expressed the opinion that capsicum aids digestion by improving circulation. Pressman, a believer in megadoses of Vitamin C in treating colds but no knowing the Vitamin C content of the product involved here, did not state an opinion as to its efficacy in the treatment of colds (Tr. 133-135).

6. Based on the opinions of Dr. Segal which I find to be better informed than those of Mr. Pressman in this matter, I find that respondent's representations as to the product CAPSICUM as alleged in the complaint are false in fact.

]. As to all the docket numbers involved I find that respondent is engaged in conducting a scheme for obtaining money or property through the mails.

2. 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).

3. Not all the representations alleged are expressly made. The words "may" or "might" are used in some of the advertisements (6/136, for example) in connection with the relief or cure offered. But 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 Consumer Council , 425 U.S. 748 (1976).

4. The average person reading respondent's advertisements would interpret them substantially as characterized in paragraph (3) of each of the complaints.

5. The qualifications of Dr. Segal were substantially superior to those of Mr. Pressman to express opinions concerning the efficacy of these products to produce the results represented by respondent. Further, the record leaves unrebutted the statements of Dr. Segal that his opinions conform to the consensus of informed medical opinion.

6. Medical Opinion need not be based on tests of the products to constitute substantial evidence of the falsity of advertising claims. Skinny Suit , P.S. Docket No. 3/44 (Postal Service Dec. 2/19/76; Original Cosmetics USDC SDNY 7/13/78.

7. Based on the opinions of Dr. Segal, I conclude that the representations made by respondent concerning the several products involved as alleged in the several complaints are materially false in fact with the exception of the representations alleged in P.S. Docket No. 6/133 and the representation alleged in P.S. Docket No. 6/138 that the product will nourish and normalize the skin as to which complainant failed to sustain its burden of proof.

8. The effect of false representations is not dispelled by a money-back guarantee. Borg-Johnson Electronics v. Christenberry, supra ; Farley v. Heininger , 105 F.2d 79 (D.C. Cir., 1939), cert. den. 308 U.S. 587 (1939).

9. Orders pursuant to 39 U.S.C. 3005, in the form attached, should be issued.