Federal Trade Commission.
Proposed consent agreement, final complaint and decision and order.
The consent agreement in this matter settles alleged violations of federal law prohibition unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint that accompanies the consent agreement and the terms of the consent order—embodied in the consent agreement—that would settle these allegations. The Commission has simultaneously issued the complaint and the consent order in final form.
Comments must be received on or before March 29, 2002.
Comments filed in paper form should be directed to: FTC/Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW, Washington, DC 20580. Comments filed in electronic form should be directed to: email@example.com, as prescribed below.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Heather Hippsley or Richard Cleland, Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, DC 20580, (202) 326-3285 or 326-3088 and Andrea Foster or James Rohrer, Federal Trade Commission, Southeast Regional Office, 225 Peachtree St., NE, Suite 1500, Atlanta, GA 30303, (404) 656-1356 or 656-1361.End Further Info End Preamble Start Supplemental Information
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Section 2.34 of the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with an accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for February 27, 2002), on the World Wide Web, at http://www.ftc.gov/os/2002/02/index.htm. A paper copy can be obtained from the FTC Public Reference Room 130-H, 600 Pennsylvania Avenue, NW, Washington, DC 20580, either in person or by calling (202) 326-2222.
Public comments are invited, and may be filed with the Commission in either paper or electronic form. Comments filed in paper form should be directed to: FTC/Office of the Secretary, Room 159-H, 600 Pennslvania Avenue, NW, Washington, DC 20580. If a comment contains nonpublic information, it must be filed in paper form, and the first page of the document must be clearly labeled “confidential.” Comments that do not contain any nonpublic information may instead be filed in electronic form (in ASCII format, WordPerfect, or Microsoft Word) as part of or as an attachment to e-mail messages directed to the following e-mail box: consentagreement@ ftc.gov. Such comments will be considered by the Commission and will be available for inspection and copying at its principal office in accordance with Section 4.9(b)(6)(ii) of the Commission's Rules of Practice, 16 CFR 4.9(b)(6)(iii)).
Analysis of Consent Order To Aid Public Comment
The Federal Trade Commission has accepted an agreement to a consent order from Kris A Pletschke, d/b/a Raw Health (“respondent”), and has issued a Complaint and the Decision and Order (“Order”) contained in the Consent Agreement. Respondent marketed “Colloidal Silver,” a dietary supplement allegedly containing submircoscopic particles of silver that was intended to be taken orally and in other manners for the cure and treatment of more than 650 diseases.
The Commission's complaint charges that respondent made false claims that his Collodial Silver product (1) is effective in treating or curing 650 diseases; (2) eliminates all pathogens in the human body in six minutes or less; and (3) has been medically proven to kill every destructive bacterial, viral and fungal organism in the body, including anthrax, Ebola, Hunta, and “flesh-eating bacteria.” The Commission's complaint also charges that respondent failed to have a reasonable basis for claims he made that his colloidal Silver product (1) is effective in treating 650 diseases and health-related conditions, including AIDS, allergies, anthrax, arthritis, blood poisoning, boils, wounds of the cornea, chronic fatigue, cerebral spinal meaningitis, candida, cholera, colitis, cystitis, dental plaque, diabetes, diphtheria, dysentery, enlarged prostate, gonorrhea, herpes, hepatitis, infantile diseases, lesions, leukemia, lupus, Lyme disease, parasites, rheumatism, ringworm shingles, skin cancer, staph and strep infections, stomach flu, thyroid conditions, tonsilitis, toxemia, stomach uclers and whooping cough; (2) kills the HIV virus and can be used as an antibiotic for all acquired diseases of active AIDS; (3) is superior to antibiotics in killing disease-causing organisms and the treatment of burns; (4) protects and strengthens the immune system; (5) can safely be used on open wounds, sprayed Start Printed Page 10216into the eye, injected, used orally, vaginally, anally, atomized or inhaled into the nose or lungs and dropped into the eyes; (6) has no side effects, even at double or tiple the normal dose of 260 ppm, and is safe for children and pregnant and nursing women; and (7) aids the growth and health of the developing fetus and cases delivery and recovery.
Part I of the consent order prohibits respondent from misrepresenting any claims that Collidal Silver or any food, dietary supplement, drug, device, or health-related service or program has been medically proven to kill disease-causing organisms or any number of infections in the body. Part II of the order requires competent and reliable scientific evidence to substantiate representations that Colloidal Silver or any covered product (1) is effective in treating 650 diseases and health-related conditions, including AIDS, allergies, anthrax, arthritis, blood poisoning, boils, wounds of the cornea, chronic fatigue, cerebral spinal meningitis, candida, cholera, colitis, cystitis, dental plaque, disabetes, diphtheria, dyesentery, enlarged prostate, gonorrhea, herpes, hepatitis, infantile diseases, lesions, leukemia, lupus, Lyme disease, parasites, rheumantism, ringworm shingles, skin cancer, staph and strep infections, stomach flu, thyroid conditions, tonsillitis, toxemia, stomach ulcers and whooping cough; (2) kills the HIV virus and can be used as an antibiotic for all acquired diseases of active AIDS; (3) is superior to antibiotics in killing disease-causing organisms and the treatement of burns; (4) protects and strengthens the immune system; (5) can safely be used on open wounds, sprayed into the eye, injected, used orally, vaginally, anally, atomized or inhaled into the nose or lungs and dropped into the eyes; (6) has no side effects, even at double or tripe the normal dose of 260 ppm, and is safe for children and pregnant and nursing women; (7) aids the growth or health of the developing fetus or eases delivery or recovery; (8) is effective in the mitigation, treatment, prevention, or cure of any disease, illness or health conditions; or (9) has any health, performance, safety, or efficacy benefits.
Part III of the order prohibits respondent from misrepresenting, including by means of metatags, the existence, contents or interpretation of any test, study, or research. Part IV of the order permits respondent to make certain claims for drugs or dietary supplements, respectively, that are permitted in labeling under laws and/or regulations administered by the U.S. Food and Drug Administration.
Part V and VI of the order require respondents to offer refunds to all of his past consumers and wholesale purchasers of Colloidal Silver. Part VII requires respondent to file a sworn affidavit with the Commission concerning his compliance with the refund provisions.
The remainder of the order contains standard requirements that respondent maintain advertising and any materials relied upon as substantiation for any representation covered by substantiation requirements under the order; distribute copies of the order to certain company officials and employees; notify the Commission of any change in the business entity that may affect compliance obligations under the order; and file one or more reports detailing his compliance with the order. Part XV of the order is a provision whereby the order, absent certain circumstances, terminates twenty years from the date of issuance.
This order will resolve the claims alleged in the complaint against the named respondent. It is not the Commission's intent that acceptance of this consent agreement and issuance of a decision and order will release any claims against any unnamed persons or entities associated with the conduct described in the complaint.
Effective Date of Order and Opportunity for Public Comment
The Commission issued the Complaint and the Decision and Order, and served them upon the Respondent, at the same time it accepted the Consent Agreement for public comment. As a result of this action, the Order has already become effective. In August 1999, the Commission adopted procedures to allow for immediate effectiveness of an Order prior to a public comment period. The Commission announced that it “contemplates doing so only in exceptional cases where, for example, it believes that the allegedly unlawful conduct to be prohibited threatens substantial and imminent public harm.” 64 FR 46267 (1999).
This case is an appropriate one in which to issue a final order before receiving public comment because the complaint alleges that the respondent made false and unsubstantiated health and safety claims of a serious nature, and the respondent continued to make the challenged claims after signing the consent agreement. Accordingly, the Commission believes it is important to prohibit the respondent from making these claims as quickly as possible.
The Order has also been placed on the public record for 30 days for receipt of comments by interested persons, and comments received during this period will become part of the public record. Thereafter, the Commission will review the Order, and may determine, on the basis of the comments or otherwise, that the Order should be modified.
The Commission anticipates that the order, as issued, will satisfactorily address the deceptive practices alleged in the Complaint. The purpose of this analysis is to invite public comment on the Order to aid the Commission in determining whether to modify the Order in any respect, and is not intended to constitute an official interpretation of the agreement and order, or to modify in any way their terms.Start Signature
By Direction of the Commission.
Donald S. Clark,
1. If the Respondent does not agree to such modifications, the Commission may (1) initiate a proceeding to reopen and modify the Order in accordance with Rule 3.72(b), 16 CFR 3.72(b), or (2) commence a new administrative proceeding by issuing an administrative complaint in accordance with Rule 3.11, 16 CFR 3.11. See 16 CFR 2.34(e)(2).Back to Citation
[FR Doc. 02-5329 Filed 3-5-02; 8:45 am]
BILLING CODE 6750-01-M