T-UP, Inc. v. Consumer Protection Division

RODOWSKY, Judge, Retired, Specially Assigned. This is an action for judicial review of an order by the Consumer Protection Division of the Office of the Attorney General (the Agency). The appellants are Neal Deoul (Deoul), Allen Hoffman (Hoffman), and T-UP, Inc., a Maryland corporation (the Company). The Agency found that the appellants had violated the Consumer Protection Act (the Act), Maryland Code (1975, 2000 Repl.Vol.), Title 13 of the Commercial Law Article (CL), by falsely advertising two products sold by the Company as cures or treatments for, inter alia, cancer, AIDS, and HIV.

Only the appellant Deoul has briefed and argued the appeal in this Court. He challenges the standard applied by the Agency to determine the falsity of advertising the products involved, the exclusion of certain evidence, and, insofar as it applies to him, the imposition, jointly and severally, of a civil penalty in the amount of $3,706,000. The Agency found that the appellants had violated the prohibition of CL § 13-303 against engaging in unfair or deceptive trade practices, in this case those defined in CL § 13-301(1), (2), (3), and (9). In relevant part those paragraphs of § 13-301 provide as follows: “Unfair or deceptive trade practices include any: “(1) False ... or misleading oral or written statement, visual description, or other representation of any kind which ³⁶ has the capacity, tendency, or effect of deceiving or misleading consumers; “(2) Representation that: “(i) Consumer goods ... or consumer services have a sponsorship, approval, accessory, characteristic, ingredient, use, benefit, or quantity which they do not have; “(3) Failure to state a material fact if the failure deceives or tends to deceive; “(9) Deception, fraud, false pretense, false premise, misrepresentation, or knowing concealment, suppression, or omission of any material fact with the intent that a consumer rely on the same in connection with: “(i) The promotion or sale of any consumer goods ... or consumer service^]” I An initial review of the general legal background of this case will assist in understanding the issues presented.

CL § 13-105 declares it to be “the intent of the General Assembly that in construing the term ‘unfair or deceptive trade practices’, due consideration and weight be given to the interpretations of § 5(a)(1) of the Federal Trade Commission Act by the Federal Trade Commission [FTC] and the federal courts.” See also Luskin’s v. Consumer Protection Div., 353 Md. 335, 352-54 , 726 A.2d 702, 710-11 (1999). Section 5 of the FTC Act, 15 U.S.C. § 45 (a)(1), prohibits “unfair or deceptive acts or practices.” Nearly forty years ago the FTC first indicated in dicta that a seller of a product violated § 5 of the FTC.Act if advertised claims for a product lacked adequate substantiation. In re Heinz W. Kirchner, 63 F.T.C. 1282 (1963), aff'd, 337 F.2d 751 (9th Cir.1964). There the FTC stated: “[W]e are inclined to think that an advertiser is under a duty, before he makes any representation which, if false, ³⁷ could cause injury to the health or personal safety of the user of the advertised product, to make reasonable inquiry into the truth or falsity of the representation.” Id. at 1294.

The FTC, in 1972, held that “it is an unfair practice in violation of the [FTC] Act to make an affirmative product claim without a reasonable basis for making that claim.” In re Pfizer, Inc., 81 F.T.C. 23 , 62 (1972). The Commission, in Pfizer, indicated how the interpretation would be applied, saying: “The question of what constitutes a reasonable basis is essentially a factual issue which will be affected by the interplay of overlapping considerations such as (1) the type and specificity of the claim made—e.g., safety, efficacy, dietary, health, medical; (2) the type of product—e.g., food, drug, potentially hazardous consumer product, other consumer product; (3) the possible consequences of a false claim—e.g., personal injury, property damage; (4) the degree of reliance by consumers on the claims; (5) the type, and accessibility, of evidence adequate to form a reasonable basis for making the particular claims. More specifically, there may be some types of claims for some types of products for which the only reasonable basis, in fairness and in the expectations of consumers, would be a valid scientific or medical basis. The precise formulation of the ‘reasonable basis’ standard, however, is an issue to be determined at this time on a case-by-case basis.

This standard is determined by the circumstances at the time the claim was made, and further depends on both those facts known to the advertiser, and those which a reasonably prudent advertiser should have discovered.” Id. at 64 (emphasis added). Pfizer’s product was a treatment for sunburn, sold as “UnBurn.” Pfizer’s ads, inter alia, stated that the product “[actually anesthetizes nerves in sensitive sunburned skin.” Pfizer, 81 F.T.C. at 57. The theory of the complaint in Pfizer was that the ads represented that “each of the statements re ³⁸ specting the pain-relieving properties of Un-Burn has been substantiated by respondent by adequate and well-controlled scientific studies or tests prior to the making of such statements.” Id. at 58 (italics omitted). The complaint, however, was dismissed because the Commission concluded that the alleged representation reasonably could not be implied from Pfizer’s advertising.

Id. at 59. Following Pfizer, the Commission embarked on a program under which advertisers were required, on demand of the Commission, to submit substantiation for their claims. See 3 G.E. Rosden, The Law of Advertising § 35.05[4][a] and [b] (2001). In March 1983 the Commission requested comments on its advertising substantiation program. 48 Fed.Reg. 10471 (Mar. 11, 1983).

Thereafter, in August 1984, the Commission issued its “Policy Statement Regarding Advertising Substantiation.” 49 Fed.Reg. 30999 (Aug. 2, 1984). That statement reaffirmed the FTC’s “commitment to the underlying legal requirement of advertising substantiation—that advertisers ... have a reasonable basis for advertising claims before they are disseminated.” The Commission announced its intent to “continue vigorous enforcement” of that legal requirement. Where an ad contained a statement “regarding the amount of support the advertiser has for the product claim,” the Commission expected the advertiser “to have at least the advertised level of substantiation.” If an ad did not express or imply substantiation for product claims, the Commission nevertheless would assume “that consumers expect a ‘reasonable basis’ for claims.” Under the 1984 policy statement, which continues in effect, the factors on which the Commission would determine whether a claim was substantiated include “the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts in the field believe is reasonable. Extrinsic evidence, such as expert testimony or consumer surveys, is useful to determine what level of substantiation consumers ³⁹ expect to support a particular product claim and the adequacy of evidence an advertiser possesses.” (Emphasis added).

The theory of the violations of the Act charged against the appellants in this case is that they lacked reasonable substantiation for their product claims. II We turn now to the general facts. In the balance of this opinion, when referring to the Consumer Protection Division in its capacity as the proponent of the charges against the appellants, we shall use “Division.” When referring to the Consumer Protection Division in its adjudicatory capacity, we shall use “Agency.” Hoffman holds an Associate of Arts degree from the Community College of Baltimore, granted in 1971. He has worked as a laboratory technician in the Fertility Control Center at Johns Hopkins Hospital, as a salesperson for several medical supply corporations, as a freelance laboratory technologist, and, in 1994, as an ultrasound technician at a health center in Pennsylvania.

Deoul holds degrees of Bachelor of Science and of Juris Doctor, awarded respectively in 1952 and 1959. When the Division sought to take the depositions of Hoffman and Deoul each deponent invoked his Fifth Amendment privilege against self-incrimination. As a sanction for their refusal to testify the Administrative Law Judge (ALJ) before whom the evidentiary hearing on the charges was held precluded Hoffman and Deoul from testifying. The Agency found that Hoffman and Deoul each falsely represented himself to hold a Ph.D. degree.

Hoffman’s misrepresentation included a fraudulent Ph.D. diploma, purportedly awarded by the University of Heidelberg in Germany. The Company was formed in early November 1996. Hoffman and Deoul each held 42.3% of the issued and outstanding shares. Hoffman was president and treasurer while Deoul was vice-president and secretary.

Deoul loaned the Company ⁴⁰ $120,000 at its inception. The organizational minutes of the Company recite that it accepted “technology” from both Deoul and Hoffman. The Company marketed and sold “T-Up,” a concentrated aloe vera extract, and cesium chloride, a mineral, as alternative medical treatments for numerous diseases and conditions. 1 Working from purchased mailing lists, the Company mailed to consumers an audio tape, featuring Hoffman and entitled “There is Hope.” The tape is in the format of a lecture before a live audience, followed by a question and answer period. A narrator opens and closes the recording.

At the end of the recording listeners are told, “You and you alone can avoid becoming another statistic. Act now and call this number to order: 410-486-5200. That’s 410-486-5200.” That number rang in the office of the. Company in the Baltimore metropolitan area.

There a staff of telephone answering sales representatives worked from a desk reference manual and from price lists. The thirty page desk reference manual described how the products worked, what the recommended dosages were for various diseases, and, in some instances, the purported success rate of the products in treating various diseases. ' When the Company filled an order from a consumer, the shipment to the customer was accompanied by a brochure entitled, “Boost Your Immune System.” Both the brochure and the. audiotape claim that T-UP is capable of boosting the body’s immune system .and thus of helping individuals .who are afflicted with a wide range of immune-related illnesses. , The letter covering transmittal of the tape and signed by Hoffman states that the Company has learned to “manipulate” the immune system so “that the body can heal itself.” The advertising matter focuses on T-Up’s claimed ability to fight cancer, AIDS, and HIV, but similar claims also'are made with regard to lupus, herpes, and arthritis, among other conditions. 2 ⁴¹ The advertisements for T-Up and cesium chloride are replete with broad statements about the disease-fighting powers of these products. The following is but a sample of such statements about T-UP: —“T-UP is effective in the treatment of most malignancies except pancreatic and brain cancers. Prostate cancer, which is slow growing tissue, responds particularly well to treatment with T-UP.” —“In the treatment of liver cancer, T-UP has been extremely successful because the liver is highly vascular and there is no problem getting into it.” —“[W]e could double the number of T-4 lymphocytes ... [which] are the cells that people with HIV lose ... roughly every three weeks.... “...

Then we noticed further that after a short period of time not only were we increasing the number of the cells that these folks were losing but we noticed a decrease in viral lode, that is a decrease in the virus that was affecting them.” —“In rheumatoid arthritis, we’re dealing with an autoimmune response and we’re going to be extremely effective.” —“The herpes virus, much like many of the other viruses, can be controlled with the administration of Aloe vera.” —“[W]e do real well if you know anybody with chronic fatigue.” ' t The Company also promoted a combination package • of TUP and cesium chloride for treating cancer. On the audio tape Hoffman in part says: . ⁴² “[C]esium chloride begins to destroy malignant tissue in three days. And my experience recently is that in ten days 50% of a malignancy will disappear. The rest of the malignancy based upon scientific literature should disappear within two to three months.” Based on a statement in the desk reference manual, the Company’s sales representatives told consumers that the Company had had a “100% success rate” in treating breast cancer with cesium chloride.

That representation was discontinued, on the advice of counsel, during the fall of 1997. Between October 1996 and May 1998 the Company mailed the audio tape to 125,000 names on mailing lists. It was stipulated that in the six month period from April 1997 through October 1997 the Company had a total of 3,706 customers. The former office manager of the Company estimated that the majority of the Company’s customers suffered from cancer and that one-third of those were in late stages.

The Company’s supplier of T-UP was Cosmetic Specialty Labs, Inc. of Lawton, Oklahoma, the president of which, Odus M. Hennessee, was a five percent shareholder in the Company. Between September 25, 1996, and October 1, 1997, Cosmetic Specialty Labs shipped 32,620 two ounce bottles of TUP to the Company. T-UP was also sold in liquid form in other sizes and as a salve, a suppository, and a douche. A sterile form of T-UP was sold for intravenous injection, which ostensibly was to take place .under the care of a physician outside of the United States.

The two ounce liquid concentrate form of T-UP retailed at $75 per bottle for purchases of less than twenty bottles. The cost to the Company of a two ounce bottle of T-UP ranged from $15.37 to $20.37. A container of 100 capsules of 500 mg. cesium chloride retailed at $75 per container when less than twenty containers were purchased. The cost to the Company of a 100 capsules container was $20.50.

Additional facts will be stated in the discussion of particular issues. ⁴³ III In the fall of 1997 both the Food and Drug Administration (FDA) and the Division launched investigations of the Company’s activities. The statement of charges that is before us was filed in May 1998, and the matter was referred to an ALJ for hearing. The hearing encompassed twenty-seven days between October 1998 and April 1999. It appears that, during the pre-hearing phase of this matter, the Division called upon the appellants to produce all documents which the appellants asserted substantiated their claims for T-UP and cesium chloride.

At the hearing the Division introduced Exhibit 56, consisting of seventy-nine subparts and containing eighty-five articles from publications, including scientific journals. The extent of any scientific literature support for the appellants’ claims lies within Exhibit 56. Consequently, expert witnesses for both sides directed a considerable portion of their testimony to the significance, vel non, of Exhibit 56. One of the experts called by the Division, Dr. Richard Humphrey, is an Associate Professor of Pathology, Medicine, and Oncology, at the Johns Hopkins School of Medicine.

For nearly two decades he was the Director of the oncology teaching program at that medical school. For approximately sixteen years he also was the Director of the Diagnostic Immunology Laboratory at the Johns Hopkins Hospital. The Division also called Dr. Joel Gallant, an Associate Professor of Medicine at Hopkins and the Director of its clinic for patients afflicted with any stage of HIV disease, including AIDS. Doctors Humphrey and Gallant explained the multi-step process of testing that is required before the medical efficacy of an experimental substance for treatment of an illness in human beings is generally accepted in the medical-scientific community.

First, the experimental substance must be consistent from one lot to another in production. Next, it is tested “in vitro,” i.e., in a laboratory setting using tissue culture cells, followed by “in vivo” testing on animals. If, at ⁴⁴ those steps, the experimental substance is shown to be both safe and efficacious, it is tested on humans through three sequential phases. Phase one usually involves a small number of healthy people who receive varying dosages to determine if the substance is toxic in humans.

Phase Two also involves a relatively small' number of patients who are divided into two groups, one of which receives the experimental substance and the other of which receives either the then standard treatment substance or a placebo. The patients do not know which treatment they are receiving. Phase three of human testing usually consists of a number of simultaneous projects at different medical institutions involving relatively large numbers of patients engaged in “double-blinded” studies. In such studies neither the patient nor the scientist who initially evaluates a patient’s response to the treatment knows which treatment the particular patient has received.

Doctors Humphrey and Gallant respectively reviewed Exhibit 56 in preparation for their testimony. They each concluded that nothing in Exhibit 56 substantiated the Company’s claims for its products by the type of scientific evidence described in their testimony. They explained why certain published articles that were produced in Exhibit 56 and that had some relevancy did not demonstrate the efficacy of T-UP and cesium chloride in the treatment of humans for disease, including cancer, AIDS, or HIV. The ALJ and the Agency accepted this testimony.

This gives rise to the first issue which we address on this appeal, i.e., whether the Agency, as a matter of law, applied an erroneous standard. In the defense case at the hearing, the appellants called as experts, Robert Barefoot, John Heggers, Ph.D., and Lawrence Pearce, M.D. Doctors Heggers and Pearce testified extensively, but, in certain areas the ALJ sustained objections by the Division and limited their testimony. In addition, the appellants called a number of customer witnesses who testified concerning their satisfaction with the Company’s products, but the appellants were not allowed to introduce, in addition, eighty affidavits from customers to the same general effect. Nor did the ALJ accept an affidavit from a registered phar ⁴⁵ macist concerning the legality of intravenous injection of “sterile” T-UP.

Based on its findings of violations of the Act, the Agency entered an extensive order, containing numerous injunctive provisions, including a requirement that the Company’s advertising affirmatively state that intravenous use of T-UP is illegal in the United States. The Agency also imposed the maximum fine of $1,000 per violation under CL § 13^110(a), treating the stipulated total of 3,706 customers during the April 1997 through October 1997 period as representing one violation per customer. In this Court Deoul vigorously contends that there was insufficient evidence to support his inclusion, jointly and severally with the other appellants, in liability for that fine. Appellants sought judicial review of the Agency decision before the Circuit Court for Baltimore County, which, with one modification not relevant here, affirmed the Agency decision.

This appeal, and a brief by Deoul, followed. IV Deoul raises the following questions, which we have reordered and rephrased: 1. Whether the Agency erred as a matter of law by imposing a rigid prerequisite of two well-controlled, double-blinded clinical studies proving safety and efficacy before any health claims about aloe vera or cesium chloride could be made? 2. Whether the ALJ’s refusal to qualify Deoul’s expert witnesses, and restrictions on the scope of their examinations, constituted an abuse of discretion and reversible legal error? 3.

Whether the ALJ abused her discretion by excluding from evidence the affidavit of Karen Weaver? 4. Whether the Agency lacked substantial evidence to support its order forcing appellants to represent in connection with any future sale of aloe vera that its intravenous use is illegal? ⁴⁶ 5. Whether the ALJ’s refusal to admit into evidence eighty (80) consumer affidavits constituted an abuse of discretion? 6. Whether, by limiting the number of consumer witnesses who could testify, the ALJ abused her discretion in view of her prior representation that she would accept affidavits from these excluded witnesses? 7.

Whether the Agency lacked substantial evidence to support its ruling that Deoul was personally liable for the wrongs of the Company? V In reviewing the decision of an administrative agency, “we reevaluate the decision of the agency, not the decision of the lower court.” Gigeous v. Eastern Correctional Institution, 363 Md. 481, 495-96 , 769 A.2d 912, 921 (2001) (citing Public Serv. Comm’n v. Baltimore Gas & Elec. Co., 273 Md. 357, 362 , 329 A.2d 691, 694-95 (1974)).

Under the Administrative Procedure Act, this Court’s review is governed by the standard and scope of review imposed upon the circuit court. See Maryland Code (1984, 1999 Repl. Yol), § 10-222(h) of the State Government Article. The scope of our review of administrative agency action is narrow and we are “not to substitute [our] judgment for the expertise of those persons who constitute the administrative agency.” United Parcel Serv., Inc. v. People’s Counsel for Baltimore County, 336 Md. 569, 576-77 , 650 A.2d 226, 230 (1994) (internal quotations omitted).

Accordingly, this Court is tasked with “ 'determining if there is substantial evidence in the record as a whole to support the agency’s findings and conclusions, and to determine if the administrative decision is premised upon an erroneous conclusion of law.’ ” Board of Phys. Quality Assurance v. Banks, 354 Md. 59, 67-68 , 729 A.2d 376, 380 (1999) (quoting United Parcel Serv., 336 Md. at 577 , 650 A.2d at 230 ). ⁴⁷ With regard to questions of fact, we will only disturb the decision of an administrative agency if “a reasoning mind reasonably could [not] have reached the factual conclusion the agency reached.” Baltimore Lutheran High Sch. Ass’n v. Employment Sec. Admin., 302 Md. 649, 662 , 490 A.2d 701, 708 (1985). Thus, “[a] reviewing court should defer to the agency’s fact-finding and drawing of inferences if they are supported by the record.” Banks, 354 Md. at 68 , 729 A.2d at 380-81 .

With regard to questions of law, “an administrative agency’s interpretations and application of the statute which the agency administers should ordinarily be given considerable weight by reviewing courts.” Id. at 69 , 729 A.2d at 381 . Such deference, however, is not warranted when the agency’s construction “override[s] the plain meaning of the statute or extend[s] its provisions beyond the clear import of the language employed.” State Dep’t of Assessments & Taxation v. Greyhound Computer Corp., 271 Md. 575, 589 , 320 A.2d 40, 47 (1974). VI (Issue 1) The standard which the Agency required the appellants to meet in order to substantiate their product claims is set forth most clearly in the Agency’s final order. It directs the appellants to cease and desist from making any representations concerning the “efficacy, performance, safety or benefits” of the Company’s products “unless, at the time the representation is made, [appellants] possess and rely upon competent and reliable scientific evidence that substantiates the representation.” The order further defines “competent and reliable scientific evidence” to mean: “tests, analysis, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

For health products such as those sold by [appel ⁴⁸ lants], competent and reliable scientific evidence shall include at least two adequate, and well-controlled, double-blinded clinical studies.” (Emphasis added). The Agency concluded, based largely on the testimony of Drs. Humphrey and Gallant, that there were no scientifically reliable tests in evidence that established aloe vera or cesium chloride as an effective treatment or cure for any form of cancer or for HTV or AIDS. 3 Deoul’s position is that the Agency erred by requiring two clinical studies because, under the Pfizer test, a reasonable basis can be found to substantiate the Company’s product claims from other forms of evidence and without any well-controlled, double-blinded, clinical,, human studies in évidence supporting' the Company’s representations. ⁴⁹ The cases applying § 5 of the FTC Act require clinical study support for products that are to be ingested by humans or applied to the human body, and many of these cases require two such studies. In FTC v. Pantron I Corp., 33 F.3d 1088 (9th Cir.1994), cert. denied, 514 U.S. 1083 , 115 S.Ct. 1794 , 131 L.Ed.2d 722 (1995), the claim was that the advertiser’s product, “The Helsinki Formula,” promoted the growth of new hair on men with male pattern baldness.

Studies on which Pan-tron relied, conducted in Finland and in France, were uncontrolled and unblinded. Id. at 1093. The FTC, however, introduced two studies, one of which was placebo-controlled, double-blinded, and randomized. Id. at 1092-93.

The Ninth Circuit reversed that portion of the district court’s injunction which permitted Pantron to advertise that its product was effective with some persons because “[sjcientific studies recognized under standards in use in the United States” failed to explain or support, and in fact refuted, the effectiveness claims. Id. at 1101. See also Removatron Int'l Corp. v. FTC, 884 F.2d 1489 (1st Cir.1989) (at least one well-controlled, double-blinded clinical test necessary to support permanent hair removing result claimed for advertiser’s radio frequency energy emitting tweezers); Thompson Med. Co. v. FTC, 791 F.2d 189 (D.C.Cir.1986) (denying review of FTC order requiring advertiser to have at least two adequate and well-controlled, double-blinded clinical studies to support claims of topical analgesic’s effectiveness in treating arthritis), cert. denied, 479 U.S. 1086 , 107 S.Ct. 1289 , 94 L.Ed.2d 146 (1987); Sterling Drug, Inc. v. FTC, 741 F.2d 1146 (9th Cir.1984) (affirming FTC order requiring two well-controlled clinical studies to support advertiser’s claim of superiority for its internal analgesic over competing products), cert. denied, 470 U.S. 1084 , 105 S.Ct. 1843 , 85 L.Ed.2d 143 (1985); American Home Prods.

Corp. v. FTC, 695 F.2d 681 (3d Cir.1982) (requiring two well-controlled clinical studies to support advertiser’s claim of superior effectiveness and freedom from side effects for its non-prescription analgesics); Porter & Dietsch, Inc. v. FTC, 605 F.2d 294 , 302 n. 5 (7th Cir.1979) (applying the Pfizer factors to diet tablets and concluding that the only reasonable ⁵⁰ basis to support claims “ ‘would be a valid scientific or medical basis’ ”), cert. denied, 445 U.S. 950 , 100 S.Ct. 1597 , 63 L.Ed.2d 784 (1980); In re Viral Response Sys., Inc., [1987-1993 Transfer Binder] Trade Reg. Rep. (CCH) ¶ 23,135 (FTC Jan. 27, 1992) (consent order prohibiting advertising of device for blowing air and medicated sprays into nasal passages as, inter alia, destroying antibodies involved in allergic reactions, unless two well-controlled, double-blinded clinical studies support the claim). The numerical and persuasive weight of authority dealing with products that are intended to be taken internally requires two clinical studies.

The obvious purpose of a second study is to see if the results claimed in one study are reproducible and confirmed by another study. Here, we are dealing with the advertising of purported cures or treatments for life-threatening diseases. Applying the FTC cases, we hold that the Agency did not err in concluding that a reasonable basis for such product claims requires at least two adequate, well-controlled, double-blinded clinical studies. Hereinafter we call this level of support the “Standard.” VII (Issue 2) We turn to Deoul’s assertions that the testimony of certain of the experts called by the defense was limited erroneously.

A decision to admit or exclude expert testimony is within the discretion of the administrative tribunal and will be upheld so long as the basic rules of fairness are observed. See Dickinson-Tidewater, Inc. v. Supervisor of Assessments, 273 Md. 245, 253-54 , 329 A.2d 18, 24 (1974). A Robert Barefoot (Barefoot), a chemist, was called by Deoul as an expert on cesium chloride. According to a written proffer filed by Deoul, the ultimate opinion to be expressed by Barefoot was that the Company’s representations in the audio ⁵¹ tape and in the brochure with respect to the efficacy and safety of cesium chloride in the treatment of many forms of cancer are accurate.

More specifically, Deoul sought to qualify Barefoot in “the use of cesium chloride in conjunction with high pH therapy and its effect on the chemistry of the human body,” in order to explain why the representations were accurate. In 1982 Barefoot became interested in diseases caused by mineral and vitamin deficiencies. He has read extensively on the subject and has written or coauthored two books in which his central premise is that “most ... degenerative diseases are caused by mineral and vitamin deficiency.” Since about 1992 Barefoot has given hundreds of lectures on this subject and currently devotes approximately seventy-five percent of his time to this pursuit. After hearing testimony on voir dire and argument that cover approximately 100 pages of transcript, the ALJ refused to qualify Barefoot as an expert on the use of cesium chloride on humans in conjunction with high pH therapy for the following reasons. “This area of expertise pertains primarily to knowledge of the human body and its chemistry, and it requires ... an expert in the human body and its chemistry. “This witness has formal education and professional training in inorganic chemistry and he has an interest in matters of organic chemistry and biochemistry in the human body.

However, he has not had any professionally supported or professionally supervised training in these areas, nor has he done any professionally competent research in these areas. “. .. He testified that he did not collaborate in professionally designed research with any other professional and instead relied on information from other people, both through reading and through discussions.” The ALJ also reasoned that Barefoot’s opinion, based upon discussions with doctors and conversations with cancer patients, would not be admitted because it was not part of a systematic or formal study. ⁵² Deoul argues that an expert’s opinion may be based on the proffered expert’s experience, including study and discussions with others. Although we have no quarrel with the general concept that an expert may be qualified “by knowledge, skill, experience, training, or education,” Maryland Rule 5-702, here Deoul sought to substantiate through Barefoot the medical efficacy and safety claims of appellants. In his proffer Deoul refers to eight papers in Exhibit 56 as support for Barefoot’s opinion, but only one contains a clinical study involving humans.

That is a paper by H.E. Sartori, “Cesium Therapy in Cancer Patients,” 21 Pharmacology, Biochemistry & Behavior, Supp. 1, at 11 (1984). While that paper reports on fifty cancer patients who were studied, on its face it is not a controlled, double-blinded study. Thus, the proffered opinion is not relevant on the issue of a violation of the Act because it does not meet the Standard. The same result is reached under an analysis of the law concerning expert opinions on new scientific developments.

The Court of Appeals has stated, in the Court approved committee note to Rule 5-702, that the rule is not intended to overrule the Frye-Reed doctrine. See Reed v. State, 283 Md. 374 , 391 A.2d 364 (1978); Frye v. United States, 293 F. 1013 (D.C.Cir.1923). Barefoot testified on voir dire that, “if you search the scientific literature, there are absolutely no doctors that ... published anything on cesium. So, therefore, they must go to the chemical world.

You look at the chemical world, there are thousands of publications, but there’s only maybe four concerning the biology. So, in other words, there are no experts except for those like myself.” By Barefoot’s own admission, his beliefs as to the efficacy of cesium chloride in the treatment or cure of cancer do not have general scientific acceptance. Under Federal Rule of Evidence 702 general acceptance in the scientific community is not a necessary precondition to the admissibility of scientific evidence. See Daubert v. Merrell ⁵³ Dow Pharm., Inc., 509 U.S. 579 , 113 S.Ct. 2786 , 125 L.Ed.2d 469 (1993).

The Court there recognized that federal trial judges would have a gatekeeping role with respect to the admissibility of opinion scientific evidence and, as guidance, presented factors for deciding admissibility. These were whether the theory can be and has been tested, 509 U.S. at 593 , 113 S.Ct. at 2796 , whether it has been subject to peer review, id. at 594 , 113 S.Ct. at 2797 , the known or potential rate of error, id. at 594 , 113 S.Ct. at 2797 , and “general acceptance.” Id. The Court emphasized that “in order to qualify as ‘scientific knowledge,’ an inference or assertion must be derived by the scientific method,” id. at 590 , 113 S.Ct. at 2795 , and that “ ‘[science] represents a process for proposing and refining theoretical explanations about the world that are subject to further testing and refinement.’ ” Id. (quoting Amicus Brief for American Association for the Advancement of Science).

In the instant case the AL J took extensive testimony from Barefoot in which he described his many discussions with doctors and patients in one way or the other involved in the use of cesium chloride in the treatment of various forms of cancer. The ALJ concluded that “this experience and study was not scientific.” His experiences seem not to have been a formal study, had not been subject to well-controlled testing on humans, and had not been subject to peer review of any consequence. Accordingly, under Frye-Reed or Daubert , there was no abuse of discretion in excluding the proffered opinion of Barefoot. In his brief in this Court Deoul for the first time argues that Barefoot’s proposed opinion would be relevant on the issue of the civil fine and Deoul’s good faith. 4 Deoul’s proffer, howev ⁵⁴ er, does not represent that any admissible evidence concerning his state of mind could be produced through Barefoot, and Deoul, of course, was precluded from personally giving any such evidence because of his refusal to testify on deposition.

Further, it was incumbent on Deoul, once the ALJ ruled that Barefoot’s opinion evidence would not be admitted, to point out any special relevance that it might have, but Deoul did not do so. B Deoul called as a witness a biologist, John Heggers, Ph.D. (Heggers). Deoul announced his intention to qualify Heggers as an expert in microbiology, clinical microbiology, immunology, and bacteriology.

The ALJ accepted the witness as an expert in immunology, microbiology, and the laboratory analysis of aloe vera. Deoul complains that the ALJ did not permit Heggers to state his opinion on the effectiveness of aloe vera to treat cancer, HIV, or AIDS. We find no preservation and, if preserved, no error, and, if error, no prejudice. Dr. Heggers is certified as a medical technologist and a clinical laboratory director.

He currently serves as a professor in the departments of surgery and of microbiology and immunology at the Graduate School of the University of Texas Medical Branch and as the Director of Clinical Microbiology at the Children’s Bum Hospital in Galveston, Texas. He has specialized in the treatment of burns and wounds and, in particular, the use of aloe vera in such treatment. Deoul refers to Dr. Heggers’s having participated in two published studies pertaining to cancer. One involved reconstructive surgery of the mouth and the other tests on animals.

His assistance in those studies dealt with bacterium. He serves as a member of a hospital team that conducts monthly morbidity and mortality evaluations of cancer patients. ⁵⁵ Deoul cites Wolfinger v. Frey, 223 Md. 184 , 162 A.2d 745 (1960), and Radman v. Harold, 279 Md. 167 , 367 A.2d 472 (1977), for the proposition that “a physician may testify as an expert witness, even if that physician is not a specialist in the area in which he wishes to testify.” These cases, however, are inapposite because Dr. Heggers does not hold a medical degree. Heggers’s testimony and arguments over the admissibility of portions of it comprise 330 pages of transcript and two days of the hearings. The ruling by the ALJ to which Deoul takes exception should be placed in perspective.

After Heggers had been qualified as an expert in the three fields set forth above, he opined, based upon studies included in Exhibit 56, “that the T-UP product is essentially as proposed in the medical representations [in the audio tape and brochure]. It has the capability and quality to do that.” Then, in a lengthy direct examination, Heggers reviewed and explained how nineteen of the Exhibit 56 articles supported his opinion that the product claims were accurate. Heggers gave his views on the relationship between the immune system and cancer, HIV, and AIDS. Heggers expressed his disagreement with the statement in one of the Exhibit 56 articles, see note 2, supra, that it would be grossly irresponsible to offer aloe vera as “an effective cancer treatment.” When asked if he had “an opinion to a reasonable degree of scientific certainty as to whether T-UP can effectively treat autoimmune disorders,” he stated his belief “that T-UP can be utilized as a product for autoimmune diseases.” The ALJ sustained the Division’s objections to Heggers’s stating opinions on the effectiveness of T-UP in treatment, on one occasion as to HIV and AIDS, and, on another occasion, as to cancer.

The claim of error has not been preserved as to either ruling. There is no proffer on the record at the time of either ruling, and Deoul has not furnished us with a record reference to any claimed proffer. Heggers acknowledged that none of the studies in Exhibit 56 were double-blinded studies. Thus, under our ⁵⁶ holding in Part VI, supra, as to the Standard, his opinion, based on certain articles in Exhibit 56, that the representations in the Company’s advertising matter were accurate, was more beneficial to appellants than they had a right to have in evidence.

Disallowing any further expansion on that opinion was not error. We also agree with the ALJ’s ruling that Heggers was not qualified to express an opinion on the treatment of all of the cancers involved in the Company’s claims, or on the treatment of AIDS and HIV. Although he is neither an oncologist nor an infectious disease specialist, this is not a case where a witness was disqualified “merely because he is not a specialist or ... has never personally performed a particular procedure.” Radman, 279 Md. at 171 , 367 A.2d at 475 . Rather, this is a case of a non-physician witness being disqualified because he lacks “sufficient knowledge ‘to express a well-informed opinion,’ ”, id. at 173 n. 2, 367 A.2d at 475 n. 2 (citation omitted), about the efficacy of aloe vera in the treatment of cancer, HIV, or AIDS.

The AL J acted within her discretion when she- concluded that further expressions of Dr. Heggers’s personal, opinion would not give her scientific guidance. In any event, the rulings, if erroneous, are not prejudicial. Heggers’s direct examination concluded with an item-by-item review of every representation in the audio tape and in the brochure, as to each of which