Inspections, Compliance, Enforcement, and Criminal Investigations
Peekay International Inc 14-Apr-04
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
April 14, 2004
Peekay International, Inc.
5620 56th Street
Maspeth, NY 11378
Dear Ms. Parekh:
This letter is in reference to your company's repackaging and labeling of Sugar Fennel Candy, which is imported by your firm and distributed to food stores. During an inspection of your firm on January 5 and 6, 2004, our investigator collected a sample of Sugar Fennel Candy. Our review of the product label and laboratory analysis of the sample found violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (CFR) can find copies of the Act and the FDA regulations in the CFR through links on FDA's home You page at www.fda.gov.
The label of Sugar Fennel Candy does not include a list of the product's ingredients. Ingredients must be listed by their common or usual names in descending order of predominance [21 CFR 101.4(a)(1)). Because the product ingredients are not declared on the label, Sugar Fennel Candy is misbranded under section 403(i)(2) of the Act.
Our laboratory analysis determined that Sugar Fennel Candy contains the artificial color additives erythrosine and Sunset Yellow FCF. These color additives require FDA batch certification for safe use [21 CFR 74.303(c), 74.706(e)]. If the foreign manufacturer of this product used certified batches of these color additives in its formulation, the color additives must be declared on the bulk product label and on your repackaged product's label as FD&C Red No. 3 and FD&C Yellow No. 6, as required by 21 CFR 101.22(k)(1). (The FD&C prefix and the term No. maybe omitted in the declaration; e.g., FD&C Red No. 3 maybe declared as Red 3.) Failure to declare certified color additives on the product label causes a product to be misbranded under sections 403(i)(2) and 403(k) of the Act.
If the erythrosine and Sunset Yellow FCF found in your product came from uncertified batches, both the bulk product and your repacked Sugar Fennel Candy are adulterated under section 402(c) of the Act in that they contain color additives that are unsafe within the meaning of section 721(a) of the Act.
This letter is not meant to be an all-inclusive list of deficiencies in your products and their labels. Other violations can subject the food to legal action. It is your responsibility to ensure that all of your products are manufactured and labeled in compliance with all applicable statutes and regulations enforced by FDA.
You should take prompt action to correct the above-referenced violations. Failure to promptly correct these violations may result in regulatory action without further notice. The Act provides for the seizure of illegal products and/or injunction against manufacturers and distributors of illegal products.
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 stated violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time at which the corrections will be completed. Your reply should be sent to Laurence D. Daurio, Compliance Officer, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433.
Jerome G. Woyshner