UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION

In the Matter of

EFAMOL NUTRACEUTICALS, INC., a corporation.

DOCKET NO.

COMPLAINT

The Federal Trade Commission, having reason to believe that Efamol Nutraceuticals, Inc. ("respondent"), has violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges:

1. Respondent Efamol Nutraceuticals, Inc., is a Delaware corporation with its principal office or place of business at 23 Dry Dock Avenue, 2nd Floor, Boston, Massachusetts 02210.

 

2. Respondent has manufactured, advertised, labeled, offered for sale, sold, and distributed numerous dietary supplements to the public, all of which contain essential fatty acids. Included among respondent's products are "Efalex" and "Efalex Focus." Respondent has marketed Efalex and Efalex Focus to parents of children with Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder ("ADD/ADHD"). Efalex and Efalex Focus are "foods" and/or "drugs," within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

 

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

 

4. Respondent has disseminated or has caused to be disseminated advertisements for Efalex and Efalex Focus, including but not necessarily limited to the attached Exhibits A through D. These advertisements contain the following statements and depictions:

 

 

A. "LONG-TERM SIDE EFFECTS MAY INCLUDE:

 

HUGGING YOUR MOM.

 

 

When your child is bouncing off the walls, hyper and aggressive, do you go crazy wishing he'd just let you love him? Efalex^TM is a dietary supplement that manages fatty acid deficiency in ADD/ADHD. It's safe and gentle, and it's available today without a prescription. In capsules or liquid. Because hugging your mom is the best medicine of all. To find out more, call 1 888 EFAMOL 1 or visit www.efamol.com."

 

(Exhibit A, Print Advertisement).

 

 

B. "FREAK

 

 

Why would anyone say such a thing? He's a beautiful kid. But sometimes beautiful kids suffer from really ugly attention and behavior problems. Luckily, Efalex^TM is here. This safe, gentle, dietary supplement, now available in capsules or liquid, manages fatty acid deficiency in ADD/ADHD. Because he's not a monster, a demon, a weirdo. He's your child. Call 1 888 EFAMOL 1 or visit www.efamol.com."

 

(Exhibit B, Print Advertisement).

 

 

C. "You'd Try Anything to Help Your Child with ADHD. Try This.

 

Studies show that some children with Attention Deficit Hyperactivity Disorder (ADHD) have a fatty acid deficiency. This is because they have problems converting essential fatty acids into the long chain forms the body needs to maintain optimum eye and brain function.

 

 

 

Only Efalex provides the precise combination of these important fatty acids -- G.A., DHA, and AA -- to properly manage this deficiency.

 

 

 

Efalex has been used by thousands of children in the United Kingdom, other parts of Europe and Australia. Manufactured by Efamol, the world leader in fatty acid research, Efalex is a safe, gentle way to manage fatty acid deficiency.

 

 

 

Now Efalex is available at your local pharmacy in the vitamin/natural products section. For more information on fatty acid deficiency and ADHD, call 1-888-EFAMOL-1 or visit www.efamol.com.

 

 

 

Efamol. Better Science for Better Nutrition."

 

(Exhibit C, Print Advertisement).

 

 

D. "Can you help him stay focused?

 

Today's children are intelligent, creative and more talented than ever, yet some find it difficult to focus on even the most everyday tasks. What causes this problem remains a mystery.

 

 

 

Nutritional research conducted at a major American university may offer hope. Studies have shown that essential fatty acids may play a role in maintaining eye and brain function. New research has shown that these nutrients may be low in some of today's overly active children.

 

 

 

More and more parents are finding out about Efalex^TM Focus -- a new dietary supplement from Efamol Ltd., the world leader in essential fatty acid research.

 

 

 

Efalex^TM Focus is a patented formula that provides an important balance of these fatty acids. It has been widely used in Europe and is now available in the U.S.

 

 

 

To learn more about Efalex^TM Focus and essential fatty acids, or to locate a store near you, call 1-888-EFAMOL-1 or visit us at www.efamol.com."

 

(Exhibit D, Print Advertisement).

 

5. Through the means described in Paragraph 4, respondent has represented, expressly or by implication, that:

 

 

A. Efalex and Efalex Focus can cure, prevent, treat or mitigate ADD/ADHD or its symptoms.

 

 

 

B. Efalex and Efalex Focus are effective in reducing attention and behavioral problems.

 

6. Through the means described in Paragraph 4, respondent has represented, expressly or by implication, that it possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 5, at the time the representations were made.

7. In truth and in fact, respondent did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 5, at the time the representations were made. There are no studies showing that children suffering from ADD/ADHD can be effectively treated by supplementation with essential fatty acids. Respondent relied on studies that do not purport to establish a link between essential fatty acid supplementation and an effect on ADD/ADHD or its symptoms. Therefore, the representation set forth in Paragraph 6 was, and is, false or misleading.

8. The acts and practices of respondent 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 day of , , has issued this complaint against respondent.

By the Commission.

Donald S. Clark
Secretary

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