Guidance for Industry: 1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen Seafood

Contains Nonbinding Recommendations

February 2009

Additional copies are available from:
Office of Food Safety
Division of Seafood Safety HFS-325
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2300 (Updated phone: 240-402-2300)
http://www.cfsan.fda.gov/guidance.html

You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 2009

Contains Nonbinding Recommendations

Table of Contents

1. Introduction
2. Discussion
3. The 1991 Letter
4. Current Contact Information

Contains Nonbinding Recommendations

Guidance for Industry^[1]
1991 Letter to Seafood Manufacturers Regarding the
Fraudulent Practice of Including Glaze (ice) as
Part of the Weight of Frozen Seafood

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.

I. Introduction

The purpose of this letter is to provide guidance to industry. The letter sets forth FDA's policy concerning the fraudulent practice of including glaze (ice) as part of the weight of frozen seafood.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Discussion

This letter was initially issued to the seafood industry in 1991, and we are putting it on our guidance page for ease of accessibility.

FDA has received information about recent increases in electronic solicitations offering to sell seafood products at less than 100% net weight (i.e. - seafood products that may include the weight of the glazing (ice) in the net weight). This letter should serve as a reminder to the entire seafood industry of our policy regarding the fraudulent practice of including glaze (ice) as part of the weight of frozen seafood.

Although the policy set forth in this letter does reflect FDA's current policy regarding this issue, the contact information has changed (see section IV below).

III. The 1991 Letter

June 4, 1991

Dear Seafood Manufacturer:

The Food and Drug Administration (FDA) is, by this 1etter, warning members of the frozen seafood industry that the net weight of frozen seafood may not include the weight of glazing (ice). FDA has received a number of complaints from seafood trade associations, the seafood industry and other Federal agencies concerning recent increases in the fraudulent practice of including glaze (ice) as part of the weight of frozen seafood such as shrimp, lobster, and fish fillets.

Section 402(b) of the Federal Food Drug and Cosmetic Act (FD&C Act) prohibits the adulteration of food by adding any substance (such as ice glaze) to increase its bulk or weight. Section 403(e)(2) of the FD&C Act and section 4(a)(2) of the Fair Packaging and Labeling Act require food to bear an accurate statement of the net quantity of contents. Overstating the net quantity of contents (such as including the weight of ice glaze) misbrands the products under these sections. Violations of this kind may be criminally prosecuted under the FD&C Act as felonies since they are committed with the intent to defraud or mislead.

We request that you take prompt action to assure that any frozen seafood you sell does not include the weight of the glaze in the net weight. Failure to promptly correct any such violations can result in regulatory action such as detention, seizure, injunction or criminal prosecution being initiated by the Food and Drug Administration without any further notice to you.

If you have any questions regarding this matter, they should be directed to the Food and Drug Administration, Mr. Martin Stutsman at 202-485-0240^*. (*See current contact information)

IV. Current Contact Information

Any questions regarding this matter should be directed to the Director of the Division of Seafood Safety in FDA's Office of Food Safety at 301-436-2300.

⁽¹⁾ This guidance has been prepared by the Division of Seafood Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.