Department of Health and Human Services

July 25, 2001

WARNING LETTER
ONPLDS 18-01

BY CERTIFIED MAIL
RETURN RECEIPT REQUESTED

David Lumley
President and CEO
EAS, Inc.
555 Corporate Circle
Golden, Colorado 80401

Dear Mr. Lumley:

The Food and Drug Administration (FDA) has reviewed the label for your Myoplex Nutrition Bar and Myoplex Nutrition Shake. Our review reveals that the labels cause these products to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (21 CFR).

These products are misbranded because the labels bear nutrient content claims that are not authorized by regulation or the Act. The claims include "Low Carb" and 86°/0 less carbs than.. ." (Myoplex bar) and "Low Carb" and "Fewer carbs per serving than . . .." (Myoplex shake) (Section 403(r)(l)(A)).

These products are further misbranded because the labels bear the statement "Glycerine and oligofructose are not included as carbohydrates" (Myoplex bar) and "Note: Fructooligosaccharide is not included as carbohydrate" (Myoplex shake). Glycerine and oligofructose/frutooligosaccharide are carbohydrates and must be included in the value declared for "Total Carbohydrate" in nutrition labeling (Sections 403(a), 403(q), and 21 CFR 101.9(c)(6)).

The above violations are not meant to be a complete list of deficiencies on your labels. It is your responsibility to ensure that all of your products labeled in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken or plan to take to correct the noted violations. Copies of revised labels for the product should be submitted. If corrective actions cannot be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.

You should direct your written reply to me at the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutritional Products, Labeling and Dietary Supplements (HFS-8 10), 200 C Street, S.W., Washington, D.C. 20204.

Sincerely yours,
/s/
John B. Foret
Director, Division of Compliance
and Enforcement
Office of Nutritional Products, Labeling
and Dietary Supplements
Center for Food Safety
and Applied Nutrition

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