Department of Health and Human Services
Public Health Service
Washington, DC 20204
March 15, 2001
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Michael Booker, President
Morven Partners, LP
9201 Arboretum Pkwy #140
Richmond, VA 79906
Ref. No. ONPLDS-07-01
Dear Mr Booker:
The Food and Drug Administration (FDA) has reviewed the label for your "Hoody's Low Salt Pleanuts." We have concluded that the above product is in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the act), and Title 21, Code of Federal Regulations (21 CFR).
"Hoody's Low Salt Peanuts" are misbranded under section 403(r)(1)(B) of the act because the label bears an unauthorized health claim. The claim "Reduces Risk of Heart Attacks & Cancer" is not authorized by regulation or the act; and therefore, the claim may not appear on the label of your product.
The product is also misbranded under section 403(r)(1)(A) of the act because the label bears an unauthorized nutrient content claim. The claim "Low Salt" is not authorized by regulation or the act. The claim "low sodium" is defined by regulation [21 CFR 101.61(b)(4)], however, the regulation also states that the term "salt" is not synonymous with "sodium" [21 CFR 101.61(c)] because salt refers to sodium chloride.
The above violations are not meant to be an all-inclusive list of deficiencies on your label. It is your responsibility to ensure that all of your products are labeled in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these deviations and prevent their fiture 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 to correct the noted violations. Copies of the revised label should also 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-810), 200 C St SW, Washington, DC 20204.
John B Foret, Jr.
Director, Division of Compliance and Enforcement
This page was posted on August 20, 2006.