Dear Shellfish Industry:
The Food and Drug Administration (FDA) is, by this letter, warning members of the shellfish industry (clams, oysters, and mussels) that the addition of water into fresh and/or fresh frozen shucked shellfish may cause the product to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Section 402(b)(4) of the FD&C Act prohibits the adulteration of food by adding any substance (such as water) to increase its bulk or volume and/or to make it appear better or of greater value than it is. Section 403(e)(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 water) 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 fresh or fresh frozen shucked shellfish you sell is not adulterated by excess water in the finished product. Failure to promptly correct any such violations can result in regulatory action such as seizure, injunction, or criminal prosecution being initiated by the FDA without any further notice to you.
If you have any questions regarding this matter, they would be directed to the FDA, Office of seafood, Mrs. Sandra Whetstone, Chief of Program and Enforcement Branch at 202-254-3995.
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Sincerely yours
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Hypertext updated by frf/kwg/cjm 2002-MAR-12