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2003년 10월 23일 07시 17분

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Alpine Industries Ordered to
Stop Unsubstantiated Claims for Ozone Generators
Alpine Industries, of Greeneville Tennessee, manufactures various consumer and commercial products and markets them through independent distributors. Its best known products are air-purification devices -- ozone generators that circulate room air through an electrically charged plate. The plate converts the oxygen into ozone that is recirculated into the room by a fan in the unit [1]. The company states that its distributors have sold more than three million of its air-purification systems since 1987 [2].

In January 2000, a federal court ordered the company to stop making health claims for its ozone generators [3,4]. In April 2001, the judge assessed a civil penalty of $1.49 million plus costs and interest against Alpine Industries and its president William J. Converse. The court also entered an injunction barring Alpine and Converse from making any claims that the "air purifiers" sold by the company remove any indoor air pollutant, except for "visible" tobacco smoke and some odors. It also cautioned the defendants that they cannot represent that these claims mean that the devices actually remove chemicals, particles, or microorganisms from indoor air. Finally, the court barred the defendants from claiming that their products prevent, or provide relief from, medical conditions of any kind or that sensors in the machines control the ozone levels in indoor spaces [5-7].

Background History
The U.S. Occupational Safety and Health Administration (OSHA) limits ozone exposure in industrial settings to 100 parts per billion (ppb) over an eight-hour day, six days per week. The FDA has set a limit of 50 ppb for the ozone from electronic air cleaners used as medical devices [1]. This standard would apply whenever such a device is marketed in interstate commerce with claims that it is effective in preventing, curing, mitigating, or treating any disease. The U.S. Environmental Protection Agency has concluded:

Available scientific evidence shows that, at concentrations that do not exceed public health standards, ozone is generally ineffective in controlling indoor air pollution. The concentration of ozone would have to greatly exceed health standards to be effective in removing most indoor air contaminants [8].

In 1990, Alpine issued a recall under which 13,000 units of its Air Electronic Air Purifier, Model 150, were fitted with smaller ozone-generating plates to reduce their ozone output. The FDA stated that this was done because the device could generate ozone in excess of the 50 ppb limit established in 21 CFR 80.1415 for devices that generate ozone by design or as a by-product [9].

In 1992, when Alpine and a sister company named Living Air Corporation were located in Minnesota, Consumer Reports rated their ozone generators "not acceptable" because they generated unsafe levels of ozone. The report also noted that in 1991, in a civil action, a Minnesota state court had found Alpine Air Products and its president had improperly claimed that ozone (a) was safe and necessary indoors, (b) had positive health benefits, and (c) had posed no risk to people with respiratory problems, and (d) that Alpine air cleaners emitted only low and harmless levels of ozone [1].

Consumers Union tested an Alpine 150 unit purchased before the Minnesota court ruling and a Living Air XL15 after the ruling. The test found that the Alpine 150 produced 90 to 180 ppb with its regular plate and 625 ppb with its power plate. The Living Air XL15 was tested for three sizes of rooms that were either sealed or had one air exchange per hour. The levels dropped below 50 ppb only for the smallest room that underwent one air exchange per hour. Consumer Reports concluded:

Ozone generators have limited value in unoccupied spaces. But we don't think they belong where people breathe [1].

You may be able to improve the air quality inside your house without spending hundreds of dollars on an air cleaner. Just opening a few windows or using the kitchen exhaust fan may do the job. In addition, you should do what you can to minimize or eliminate sources of air pollution [10].

For those who feel they must have an air cleaner, the magazine recommended choosing an electrostatic or high-efficiency-arresting (HEPA) model designed to clean a whole room. The models tested by Consumer Reports are no longer marketed. According to the company's attorney William A. Erhart, the product was redeveloped with a better type of ionizer and a hepa-like filter [11,12]. Attorney Erhart also contends that Consumer Reports got an artificially high reading by testing the device at its maximum output rather than by following the instructions for normal use [12].

Federal Enforcement Actions
In 1995, the FTC charged that Alpine and Living Air were making unsubstantiated representations. The case was settled with a consent agreement in which the companies and their president, William J. Converse, agreed not to make unsubstantiated claims that:

Their products eliminate or clear specified chemicals, gasses, mold, mildew, bacteria and viruses, or dust from the environment.
The use of ozone is more effective than air cleaners using filters in cleaning or purifying indoor air.
The products do not create harmful by-products.
The products prevent or provide relief from allergies, asthma, and other specified conditions [13].
Violations of FTC consent agreements can trigger penalties of up to $11,000 per day per violation. (In 1995, it was $10,000 per day.) In December 1997, at the FTC's request, the U.S. Department of Justice filed a federal court suit charging that Alpine had continued to make claims for which it lacked competent scientific evidence [14]. A product brochure, for example, had stated:

ARE YOU LIVING IN A SICK HOUSE? And is it making you sick too? Many otherwise unexplained physical ailments can probably be traced to dust, various chemicals, bacteria and a host of other airborne pollutants trapped inside with you -- inside where you spend 90% of your time. . . .

Revitalize your indoor air at home with the power of a Living Air Model 880. The 880 replicates nature by emitting ozone and negative ions into the air. This effect, the same one created by a thunderstorm or waterfall, freshens otherwise stale indoor air by oxidizing airborne pollutants and knocking down floating particulate [15].

The case was tried in October 1999, after which the jury issued a verdict that generally favored the FTC but supported claims that Alpine's generators could eliminate or reduce odors. The jury also concluded that the devices could remove visible tobacco smoke but not the airborne particles or gasses in the smoke. On January 10, 1999, a federal judge issued an injunction barring Alpine from making any claim or representation that:

Any Alpine product can eliminate, remove, clear, or clean from indoor air any quantity of any pollutant, contaminant, microorganism (including bacteria, viruses, molds, and mildew), chemical or particulate, with the exception of "tobacco smoke"
Alpine's products prevent or provide relief from any health or medical condition of any kind
The sensor installed on any of its air cleaning machines is capable of controlling the ambient level of ozone in indoor air.
The injunction also ordered the company to notify its distributors of the ruling [4].

Shortly this order was issued, Alpine sold its marketing operations to EcoQuest International, a new corporation. Michael Jackson, who had been Alpine's vice president in charge of marketing, was the purchaser. It also issued a statement that:

The jury was not judging the effectiveness of Alpine's products only the depth of Alpine's scientific evidence. This is an important distinction. A more accurate accounting of the verdict is that the jury agreed with the government's contention that Alpine did not have sufficient, reliable scientific evidence to support these claims. Once the new research is complete, we hope to have substantiation on additional product benefits. Until then, we encourage our customers to use the three-day product trial period to determine what personal benefits they might receive [16].

Alpine's reference to the three-day trial period is interesting. In January 1999, Convergys Marketing Research and Database Consulting Services interviewed 800 purchasers whose names were selected from a random sample of warranty cards that had been sent to Alpine during the previous two years. The survey found: (a) 94% of the purchasers bought the product after taking advantage of the free in-home trial; (b) based on the trial -- 98% had concluded that the product was extremely effective in reducing odors, reducing dust, pollen, and other particles, and reducing molds, mildews, and bacteria; and (c) 97.2% were satisfied with the product at the end of the three-day trial [17]. Attorney Erhart included this report with a letter to me in which he stated that "97% of the people who purchase the product are satisfied." [11] The obvious question is why the survey didn't ask how the customers felt later. To measure customer satisfaction, the proper approach would be to ask how the purchasers felt about the device after at least a year rather than three days. The Convergys survey was guaranteed to find a high satisfaction level among new purchasers, because dissatisfied users would have been unlikely to buy the device. Moreover, short-term satisfaction is not a reliable indicator of effectiveness against the symptoms of allergy, which can vary considerably from day to day and season to season.

On April 11, 2000, the FTC and U.S. Department of Justice filed a motion asking the court hold Alpine, Converse, Jackson, and EcoQuest in civil contempt. The government's motion alleged that Alpine and Converse had violated the January order by making prohibited claims about their ozone generators and that Jackson and EcoQuest, although not specifically named in the order, are bound by its terms [18]. The judge agreed [7,19]. His $1.49 million penalty represents $1,000 per day for 1,490 days of "continuing failure to obey" the 1995 order against making unsubstantiated claims [5].

Alpine now describes the judge's verdict as a "victory" for the company because the judge established a method for presenting the FTC with evidence supporting its air-purification equipment [20]. However, the judge merely said that (a) the FTC would have to respond in timely fashion; and (b) if the agency rejects the evidence, Alpine can appeal to the court [7]. The standard necessary for modifying injunction is still "competent and reliable scientific evidence."

Meanwhile, EcoQuest has been marketing soaps, hair products, and other consumables, two of which are advertised with questionable claims:

Aloe Cleanse is said to provide "a gentle cleansing for the colon and to be "an effective aid to detoxification." This description is questionable because aloe vera is a relatively harsh laxative and laxatives do not "detoxify" the body.
Pain Relief Therapy is promoted with the statement: "You no longer have to suffer the pain of inflammation associated with such conditions as arthritis, bursitis, sciatica, leg cramps or carpal tunnel syndrome. A uniquely formulated cream with 11 approved homeopathic medicines which will help to provide relief so you can continue your busy lifestyle." This claim is dubious because the FDA has never "approved" a homeopathic medicine for any type of pain relief. The Homeopathic Pharmacopeia lists ingredients that can be used in homeopathic products but says nothing about what they are for [21]. Moreover, even powerful drugs cannot ensure that the user will "never again" suffer from pain caused by inflammation.
For Additional Information on Ozone Generators
U.S. Environmental Protection Agency Statement
Questions and answers. Air cleaners designed to intentionally generate ozone (ozone generators)
References
Ozone Generators: Two not judged acceptable. Consumer Reports 57:661, 1992.
Alpine Industries. Jury in FTC/Alpine industries case sets appropriate guidelines for product claims. Company founder and president calls verdict "anti-climatic" since majority of claims exist in discontinued literature. News release, Nov 1, 1999.
Judge orders Alpine Industries to stop making unsupported claims for ozone generating air cleaner. FTC News release, Jan 18, 2000.
Inman DH. Order. United States of America v. Alpine Industries, Inc., and William J. Converse. United States District Court Eastern District of Tennessee at Greeneville. No 2:97-CV.509, Jan 10, 1999. [Download PDF]
Court-entered penalty judgment. FTC news release, April 17, 2001.
Inman DH. Judgment. United States of America v. Alpine Industries, Inc., and William J. Converse. United States District Court Eastern District of Tennessee at Greeneville. No 2:97-CV.509, Filed April 5, 2001. [Download PDF]
Inman DH. Memorandum opinion. United States of America v. Alpine Industries, Inc., and William J. Converse. United States District Court Eastern District of Tennessee at Greeneville. No 2:97-CV.509, Filed April 5, 2001. [Download PDF]
Ozone generators that are sold as air cleaners: An assessment of effectiveness and health consequences. U.S. Environmental Protection Agency Web site. Accessed Dec 26, 1999.
FDA Enforcement Report, April 16, 1991.
Household air cleaners: Our tests show that these machines can reduce dust and smoke, but they can't get rid of odors. Consumer Reports 57:657-662, 1992.
Erhart WA. Letter to Dr. Stephen Barrett, Oct 5, 2000.
Erhart WA. Letter to Dr. Stephen Barrett, Jan 5, 2001.
Marketers of ozone-generator air cleaners agree to settle FTC charges. FTC news release, June 4, 1995.
FTC seeks civil penalties against ozone-generator firm over air cleaning claims in violation of prior order. FTC News release, Jan 5, 1998.
United States of America vs Alpine Industries and William J. Converse. United States District Court for the Eastern District of Tennessee, Northeastern Division.
Alpine Industries.Alpine Industries responds to January 18 FTC injunction. New policies and corrective steps were already in place; company remains focused on its core business of removing smoke, odor from indoor air. News release, Jan 19, 2000.
Good RT. Expert report of Richard T. Good, March 26, 1999.
Government seeks civil contempt against Alpine Industries. FTC news release, April 18, 2000.
Inman DH. Order. United States of America v. Alpine Industries, Inc., and William J. Converse. United States District Court Eastern District of Tennessee at Greeneville. No 2:97-CV. 509, Sept 6, 2000.
Alpine industries. Judge rules in favor of Alpine's request: Court orders review protocol. News release, April 9, 2001.
Barrett S. Homeopathy: The ultimate fake. Quackwatch, revised May 26, 2001.

MLM Watch Home Page

This article was revised on March 13, 2002.

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