[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]


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FEDERAL TRADE COMMISSION

[File No. D09267]


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

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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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