[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