The maker of an over-the-counter calcium supplement and the Federal Trade Commission have agreed to settle charges that advertising claims it made about the product’s effectiveness in preventing osteoporosis and its superiority to other calcium supplements were unsubstantiated. To settle the FTC charges, Metagenics, Inc., doing business as Ethical Nutrients, and its president Jeffrey Katke, have agreed to rely upon competent and reliable scientific evidence to substantiate certain health, efficacy or superiority claims in the future.
Metagenics is based in San Clemente, California. Its calcium supplement is called "Bone Builder."
On August 16, 1994, the Commission issued a complaint seeking an order to halt certain allegedly deceptive advertising claims used to market "Bone Builder." Following a trial, Administrative Law Judge Lewis F. Parker found that respondents did not have adequate scientific evidence to support their claims that Bone Builder restores lost bone; restores bone strength; reduces or eliminates pain associated with bone ailments; is superior to and/or more effective than other forms of calcium in the prevention or treatment of bone ailments; and is more bioavailable, more absorbable, or more effectively utilized by the body than other forms of calcium. Judge Parker did find, however, that respondents had substantiated representations that the product builds bone; halts or prevents bone loss or bone thinning; and halts, prevents or treats osteoporosis. Prior to the Commission’s review of Judge Parker’s decision, which both the Commission staff and Metagenics had appealed, the parties reached a settlement resolving the dispute.
In conjunction with the settlement, the Commission will be issuing an amended complaint alleging that Metagenics did not have adequate substantiation for advertising claims 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;
- users of Bone Builder will not experience bone loss or osteoporosis;
- Bone Builder restores bone strength;
- Bone Builder reduces or eliminates pain associated with bone ailments; and
- 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.
In the amended complaint, the Commission notes the importance of adequate calcium intake to bone health. For example, in conjunction with other factors, adequate calcium intake can play a significant role in reducing the rate of bone loss and protecting bone strength, and individuals who do not consume adequate calcium are at greater risk of experiencing bone fractures than those who do.
"Osteoporosis disables -- and even kills -- thousands of women every year," said Jodie Bernstein, Director of the Federal Trade Commission’s Bureau of Consumer Protection. "One of the best defenses against osteoporosis in the later years is a healthy lifestyle from childhood all the way through menopause. Regular exercise and sufficient calcium are among the best weapons we have to reduce the risk of this crippling disease. In this case, the company went too far in claiming that Bone Builder is superior to other sources of calcium, and in suggesting that users would never experience bone loss or that Bone Builder could reverse the damage already done by osteoporosis."
To settle the FTC charges, Metagenics will be barred from making any health-related claims for products containing calcium unless they have adequate scientific evidence to back them up. The settlement also bars misrepresentations about the results of any studies or tests and requires that Metagenics have scientific evidence to support any superiority claims for foods, drugs, or supplements. In addition, Metagenics will be prohibited from making any claims about the relationship between calcium or osteoporosis unless they either comply with FDA rules on the subject or have competent and reliable scientific evidence to support their representations.
The Commission vote to accept the proposed consent agreement for public comment was 5-0.
Copies of the complaint and consent are available on the Internet at the FTC’s World Wide Web site at: http://www.ftc.gov and from the FTC’s Public Reference Branch, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580; 202-326- 2222; TTY for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
(FTC File No. S039 491)
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