Natural Organics Settles with FTC Over ADHD Claims

WASHINGTON--Melville, N.Y.-based Natural Organics Inc. and its president and founder, Gerald Kessler, settled with the Federal Trade Commission (FTC) to retract unsubstantiated claims in regard to the product line Pedi-Active A.D.D., containing phosphatidylserine (PS) and 2-dimethylaminoethanol bitartrate (DMAE). The products included a 60-ct. bottle of chewables, a sublingual spray and a nutrition bar.

FTC (www.ftc.gov) first issued the complaint against Natural Organics Inc. (d/b/a Nature's Plus) last August. The agency found that the company could not substantiate the claims it made in its labeling and advertising. The company claimed its Pedi-Active line may improve scholastic performance, increase attention span and control other symptoms related to ADD (Attention Deficit Disorder) and its interchangeable term, ADHD (Attention Deficit Hyperactive Disorder).

When FTC first approached Natural Organics (www.naturesplus.com) last year, the company submitted 18 double blind studies to support its product claims. According to the company, DMAE--a biochemical that is closely related to choline--may increase the brain's choline supply and improve learning capabilities, attention span and behavioral control. PS, on the other hand, is a naturally occurring substance found mainly in the brain. It had been found to promote the circulation of acetylcholine and dopamine in the brain, assisting in attention, learning and memory.

However, FTC alleged that Natural Organics did "not possess competent and reliable scientific evidence at the time they disseminated the Pedi-Active A.D.D. advertisements." In addition, the agency stated that most scientific evidence came post-claim, which is not relevant in regard to liability.

"When there is a health claim regarding children, it raises FDA's antenna that much more," said Matthew Gold, lawyer for the Bureau of Consumer Protection.

In the proposed consent agreement announced July 31, the company is prohibited from claiming that Pedi-Active A.D.D. can improve affected children's symptoms unless there is reliable, scientific evidence substantiating those claims. In addition, Natural Organics may not use "A.D.D." on its product or in its advertising.

The products now go by Pedi-Active Chewables, Pedi-Active Spray and Pedi-Active Bar, and the company's Web site has been updated to show these changes. Calls to Natural Organics and the law firm that represented the company (Washington-based Hyman, Phelps & McNamara) were not returned by press time.