97-10971. Metagenics, Inc.; Jeffrey Katke; Analysis to Aid Public Comment  

  • [Federal Register Volume 62, Number 82 (Tuesday, April 29, 1997)]
    [Notices]
    [Pages 23245-23246]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-10971]
    
    
    =======================================================================
    -----------------------------------------------------------------------
    
    FEDERAL TRADE COMMISSION
    
    [File No. D09267]
    
    
    Metagenics, Inc.; Jeffrey Katke; Analysis to Aid Public Comment
    
    AGENCY: Federal Trade Commission.
    
    ACTION: Proposed consent agreement.
    
    -----------------------------------------------------------------------
    
    SUMMARY: The consent agreement in this matter settles alleged 
    violations of federal law prohibiting unfair or deceptive acts or 
    practices or unfair or deceptive acts or practices or unfair methods of 
    competition. The attached Analysis to Aid Public Comment describes both 
    the allegations in the draft complaint that accompanies the consent 
    agreement and the terms of the consent order--embodied in the consent 
    agreement--that would settle these allegations.
    
    DATES: Comments must be received on or before June 30, 1997.
    
    ADDRESSES: Comments should be directed to: FTC/Office of the Secretary, 
    Room 159, 6th St. and Pa. Ave., NW., Washington, DC 20580.
    
    FOR FURTHER INFORMATION CONTACT:
    Lesley Ann Fair, Federal Trade Commission, S-4002, 6th St. and Pa. 
    Ave., NW., Washington, DC 20580. (202) 326-3081.
    
    SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
    Trade Commission Act, 38 Stat. 721, 15 USC 46, and Section 3.25 of the 
    Commission's Rules of Practice (16 CFR 3.25), notice is hereby given 
    that the above-captioned consent agreement containing a consent order 
    to cease and desist, having been filed with and accepted, subject to 
    final approval, by the Commission, has been placed on the public record 
    for a period of sixty (60) days. The following Analysis to Aid Public 
    Comment describes the terms of the consent agreement, and the 
    allegations in the accompanying complaint. An electronic copy of the 
    full text of the consent agreement package can be obtained from the 
    Commission Actions section of the FTC Home Page (for April 22, 1997), 
    on the World Wide Web, at ``http://www.ftc.gov/os/actions/htm.'' A 
    paper copy can be obtained from the FTC Public Reference Room, Room H-
    130, Sixth Street and Pennsylvania Avenue, NW., Washington, DC 20580, 
    either in person or by calling (202) 326-3627. Public comment is 
    invited. Such comments or views 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)(ii)).
    
    Analysis of Proposed Consent Order to Aid Public Comment
    
        The Federal Trade Commission has accepted, subject to final 
    approval, an agreement to a proposed consent order from Metagenices, 
    Inc. and its officer and director, Jeffrey Katke.
        The proposed consent order has been placed on the public record for 
    sixty (60) days for reception of comments by interested persons. 
    Comments received during this period will become part of the public 
    record. After sixty (60) days, the Commission will again review the 
    agreement and the comments received and will decide whether it should 
    withdraw from the agreement or make final the agreement's proposed 
    order.
        On August 16, 1994, the Commission issued a complaint against 
    respondents, alleging that they made deceptive claims in advertisements 
    for Bone Builder, a calcium supplement. After an administrative trial, 
    the Administrative Law Judge issued an Initial Decision on October 22, 
    1996, from which both complaint counsel and respondents filed notices 
    of appeal. On January 7, 1997, the Commission granted a Joint Motion to 
    Withdraw from Adjudication to consider the proposed consent agreement 
    in this case.
        The Commission has issued an amended complaint, clarifying some of 
    the allegations in the August 16, 1994, complaint. The amended 
    complaint alleges that respondents represented without substantiation 
    that post-menopausal women who have already lost bone and who use Bone 
    Builder will experience no additional bone loss and will achieve a 
    growth of new bone greater than the amount of bone lost; that users of 
    Bone Builder will not experience bone loss or osteoporosis; that Bone 
    Builder restores bone strength; that Bone Builder reduces or eliminates 
    pain associated with bone ailments; and that Bone Builder is more 
    bioavailable, more absorbable, or more effectively utilized by the body 
    than other forms of calcium or is more effective than other forms of 
    calcium in the prevention or treatment of bone ailments. The amended 
    complaint also states that respondents relied upon a reasonable basis 
    to substantiate that adequate calcium intake has many benefits and is 
    one of the essential factors in the body's ongoing process of removal 
    of old bone and replacement by new bone; in conjunction with other 
    factors, adequate calcium intake can play a significant role in 
    reducing the rate of bone loss or bone thinning and in protecting bone 
    strength; and individuals who do not consume adequate calcium are at 
    greater risk of experiencing bone fractures than those who do.
        The proposed consent order contains provisions designed to remedy 
    the violations charged and to prevent respondents from engaging in 
    similar acts and practices in the future. In advertising or selling any 
    food, drug, or supplement, Part I of the order requires respondents to 
    rely on competent and reliable scientific evidence to support any claim 
    that post-menopausal women who have lost bone and who use the product 
    will experience no additional bone loss or will achieve a growth of new 
    bone greater than the amount of bone loss or that users of the product 
    will not experience bone loss. Part I requires the same level of 
    substantiation
    
    [[Page 23246]]
    
    for any claim that a food, drug, or supplement restores bone strength, 
    reduces or eliminates pain associated with bone ailments, or is 
    superior to any other form of calcium in bioavailability, 
    absorbability, utilization by the body, or treatment or prevention of 
    bone ailments.
        In advertising or selling any food drug, or supplement, Part II 
    forbids respondents from misrepresenting the existence, contents, 
    validity, results, conclusions or interpretations of any test or study. 
    In making claims regarding the relationship between calcium and 
    osteoporosis, Part III requires respondents to limit themselves to the 
    health claims authorized by the Food and Drug Administration, as set 
    forth in 58 FR 2665 (1993), or to have competent and reliable 
    scientific evidence to support the claims.
        Part IV requires respondents to possess competent and reliable 
    scientific evidence to support health-related claims for products 
    containing calcium, and to have scientific substantiation for health-
    related superiority claims for any food, drug, or supplement.
        Part V allow respondents to make representations that are 
    specifically permitted by FDA regulations promulgated pursuant to the 
    Nutrition Labeling and Education Act of 1990. Part VI allows 
    respondents to make any claim for a drug that is permitted in labeling 
    for that drug under any tentative or final FDA standard or under any 
    FDA-approved new drug application.
        Parts VII through X relate to respondents' obligations to make 
    available to the Commission materials substantiating claims covered by 
    the order; to notify the Commission of changes in Metagenics's 
    corporate structure; to notify the Commission of changes in Mr. Katke's 
    employment or business affiliations; and to provide copies of the 
    orders to certain Metagenics personnel. Part XI provides that the order 
    will terminate after twenty years under certain circumstances. Part XII 
    requires respondents to file periodic compliance reports with the 
    Commission.
        The purpose of this analysis is to facilitate public comment on the 
    proposed order, and it is not intended to constitute an official 
    interpretation of the agreement and proposed order or to modify in any 
    way their terms.
    
    Donald S. Clark,
    Secretary.
    [FR Doc. 97-10971 Filed 4-28-97; 8:45 am]
    BILLING CODE 6750-01-M
    
    
    

Document Information

Published:
04/29/1997
Department:
Federal Trade Commission
Entry Type:
Notice
Action:
Proposed consent agreement.
Document Number:
97-10971
Dates:
Comments must be received on or before June 30, 1997.
Pages:
23245-23246 (2 pages)
Docket Numbers:
File No. D09267
PDF File:
97-10971.pdf