UNITED STATES OF AMERICA
BEFORE FEDERAL TRADE COMMISSION

In the Matter of

METAGENICS, INC., a corporation doing business as Ethical Nutrients and
JEFFREY KATKE, individually and as an officer of said corporation.

DOCKET NO. 9267

AMENDED COMPLAINT

The Federal Trade Commission, having reason to believe that Metagenics, Inc., a corporation, doing business as Ethical Nutrients, and Jeffrey Katke, individually and as an officer of said corporation ("respondents"), have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest, alleges:

PARAGRAPH ONE: Respondent Metagenics, Inc., doing business as Ethical Nutrients, is a corporation organized, existing, and doing business under and by virtue of the laws of the State of California, with its principal office or place of business at 971 Calle Negocio, San Clemente, California 92672.

Respondent Jeffrey Katke is an officer of Metagenics, Inc. Individually or in concert with others, he formulates, directs and controls the acts and practices of the said corporation, including the acts and practices alleged in this complaint. His business address is 971 Calle Negocio, San Clemente, California 92672.

PARAGRAPH TWO: Respondents have manufactured, advertised, offered for sale, sold and distributed an orally-ingested product containing microcrystalline hydroxyapatite ("MCHC"), minerals and protein, under the name Bone Builder (hereinafter "MCHC" or "Bone Builder"). Respondents also offer for sale and sell the MCHC product to other parties who market the product under their own brand names. Bone Builder is a food and/or drug, as the terms "food" and "drug" are defined in Sections 12 and 15 of the Federal Trade Commission Act.

PARAGRAPH THREE: The acts and practices of respondents alleged in this complaint have been in or affecting commerce, as "commerce" is defined in Section 4 of the Federal Trade Commission Act.

PARAGRAPH FOUR: Respondents have disseminated or have caused to be disseminated advertisements and promotional materials for Bone Builder, including but not necessarily limited to the attached Exhibits A through D. These advertisements and promotional materials contain the following statements:

1. The superior form of calcium proven to build bone. The latest research shows "microcrystalline hydroxyapatite" is the superior form of calcium that can build bone. We call this exciting Ethical Nutrient's [sic] product: BONE BUILDER. (Exhibit A).

 

2. Some calcium supplements can be worse than not taking anything at all. At best, others may slow bone loss, occasionally stopping it. But, BONE BUILDER can restore lost bone and has the clinical evidence to prove it! (Exhibit A).

 

3. A significant statement recurs in a number of reports: MCHC either reduces or totally eliminated bone pain, which was not found true of any other substance. (Exhibit A).

 

4. Only MCHC provides calcium in an "extremely bioavailable form" and the studies on it have "also indicated the superiority of the substance over traditional soluble calcium supplements." Of the substances used for experimentation to halt the progress of osteoporosis, only microcrystalline hydroxyapatite was considered to be totally free of "major potential hazard [sic]," which indicated its use for both "the treatment and prevention of osteoporosis." (Exhibit A).

 

5. These are just a few of the controlled clinical trials to be found in medical literature. The consensus of which is that microcrystalline hydroxyapatite halted bone loss, decreased pain and increased bone thickness when taken in adequate amounts over long periods of time, a record no calcium supplement could achieve. (Exhibit B).

 

6. Contains most absorbable kind of calcium. (Exhibit C).

 

7. BONE BUILDER is pure microcrystalline hydroxyapatite compound (MCHC), a substance which has been scientifically demonstrated to be the most effectively utilized source of calcium known. (Exhibit C).

 

8. Most importantly, no other product in the United States is as effective at preventing bone loss. (Exhibit C).

 

9. [R]esearch of the many common forms of calcium used in the trials demonstrated effectively that only one form of calcium was capable of preventing bone thinning and actually restoring bone strength, and that was "whole bone extract (microcrystalline hydroxyapatite concentrate) . . . ." (Exhibit D).

 

10. Where there is evidence that osteoporosis "runs in the family," and where there is evidence that calcium loss is already taking place, i.e. muscle spasms, receding gums, or loss of height, the ability of microcrystal-line hydroxyapatie [sic] (bone) concentrate places prevention as a matter of the individual sufferer's choice. This safe, reliable, inexpensive, scientifically-tested preventive is his/hers to take as they choose . . . . (Exhibit D).

PARAGRAPH FIVE: Through the use of the statements contained in the advertisements and promotional materials referred to in PARAGRAPH FOUR, including but not necessarily limited to the advertisements and promotional materials attached as Exhibits A through D, respondents have represented, directly or by implication, that:

1. post-menopausal women who have lost bone and who use Bone Builder or MCHC will experience no additional bone loss or bone thinning and will achieve a growth of new bone and increased bone thickness greater than the amount of bone lost;

 

2. users of Bone Builder or MCHC will not experience bone loss, bone thinning, or osteoporosis;

 

3. Bone Builder or MCHC restores bone strength;

 

4. Bone Builder or MCHC reduces or eliminates pain associated with bone ailments; and

 

5. Bone Builder or MCHC 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.

PARAGRAPH SIX: Through the use of statements contained in the advertisements and promotional materials referred to in PARAGRAPH FOUR, including but not necessarily limited to the advertisements and promotional materials attached as Exhibits A through D, respondents have represented, directly or by implication, that at the time they made the representations set forth in PARAGRAPH FIVE, respondents possessed and relied upon a reasonable basis that substantiated such representations.

PARAGRAPH SEVEN: In truth and in fact, at the time respondents made the representations set forth in PARAGRAPH FIVE, respondents possessed and 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. However, respondents did not possess and rely upon a reasonable basis that substantiated the representations in PARAGRAPH FIVE. Therefore, the representation set forth in PARAGRAPH SIX was, and is, false and misleading.

PARAGRAPH EIGHT: Through the use of the statements contained in the advertisements and promotional materials referred to in PARAGRAPH FOUR, including but not necessarily limited to the advertisements and promotional materials attached as Exhibits A through D, respondents have represented, directly or by implication, that scientific research, including clinical tests, scientific papers and/or scientific studies, proves that:

1. post-menopausal women who have lost bone and who use Bone Builder or MCHC will experience no additional bone loss or bone thinning and will achieve a growth of new bone and increased bone thickness greater than the amount of bone lost;

 

2. users of Bone Builder or MCHC will not experience bone loss, bone thinning, or osteoporosis;

 

3. Bone Builder or MCHC restores bone strength;

 

4. Bone Builder or MCHC reduces or eliminates pain associated with bone ailments; or

 

5. Bone Builder or MCHC is more effectively utilized by the body than other forms of calcium or is superior to or more effective than other forms of calcium in the prevention or treatment of bone ailments.

PARAGRAPH NINE: In truth and in fact, the representations set forth in PARAGRAPH EIGHT have not been proven by scientific research, including clinical tests, scientific papers and/or scientific studies. Therefore, the representations set forth in PARAGRAPH EIGHT were, and are, false and misleading.

PARAGRAPH TEN: The acts and practices of respondents as alleged in this complaint constitute unfair or deceptive acts or practices and the making of false advertisements in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.

THEREFORE, the Federal Trade Commission this twenty-third day of October, 1997, has issued this amended complaint against respondents.

By the Commission, Commissioner Anthony not participating..

Donald S. Clark
Secretary

[Exhibits A-D attached to paper copies of complaint, but not available in electronic form.]