| Public Health Service Food and Drug Administration |
| 555 Winderley Pl., Ste. 200 Maitland, FL 32751 |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
May 21, 2010
Mr. Maxwell A. Freymuller
President
Mickey's Snacks & Concession Supply Co.
305 Bear Ridge Circle, Suite 105
Palm Harbor, FL 34683-5484
Dear Mr. Freymuller:
The U.S. Food and Drug Administration (FDA) inspected your food processing facility, located at the above address, November 30, 2009 through December 1, 2009. Our review of your company's popcorn found that the product was not labeled. Due to your failure to label your popcorn product, and other evidence collected during the inspection, FDA has determined that your product is misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and Title 21, Code of Federal Regulations (CFR) Part 101. You may find the Act and the food labeling regulations through links in the FDA's home page at www.fda.gov.
Your popcorn is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], including your failures to (1) label with the common and usual name of the food; (2) label with the common and usual names of the ingredients; (3) label with the name and place of your business; and (4) declare all major food allergens present in your popcorn.
Your popcorn is misbranded under section 403(i)(1) of the Act [21 U.S.C. § 3430)(1)] in that the product fails to bear the common or usual name of the food and to do so as specified by 21 CFR 101.3.
Your popcorn is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the popcorn is fabricated from two or more ingredients, but fails to bear the common or usual name of each ingredient as specified by 21 CFR 101.4. Our investigation found that you use (b)(4) Buttery Popcorn Salt in preparing your finished popcorn. (b)(4) Butter Popcorn Salt contains the following ingredients: salt, silicone dioxide, coconut oil, yellow 5, yellow 6 and natural and artificial flavors. Your unlabeled popcorn fails to declare any of them. The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
Your popcorn is misbranded within the meaning of Section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that the unlabeled package does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
Finally, your popcorn is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that you fail to declare all major food allergens present in your product. As stated above, you use (b)(4) Buttery Popcorn Salt to produce your popcorn. Milk and soy are listed on the label of (b)(4) Buttery Popcorn Salt. Section 201 (qq) of the Act [21 U.S.C. § 321 (qq)] defines as "major food allergens" milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredients containing proteins derived from one of these foods, with the exception of highly refined oils or ingredients derived from such oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• The word "Contains", followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [Section 403(w)(1)(A) of the Act; 21 U.S.C. § 343 (w)(1)(A)], or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source that appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act; 21 U.S.C. § 343 (w)(1)(B)].
We note, also, that coconut oil is listed in the ingredient statement of the (b)(4) Buttery Popcorn Salt. Coconut is a tree nut under the Act and, therefore, it and its products are a major food allergen. See, e.g., Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance. Section 201(qq)(2)(A) of the Act [21 U.S.C. § 321(qq)], however, provides an exemption for highly refined oils. It is your responsibility to determine whether the coconut oil used in the (b)(4) Buttery Popcorn Salt is highly refined and, therefore, whether it is subject to the allergen source labeling requirements of Section 403(w) [21 U.S.C. § 343(w)]. Additional information about allergen source labeling is available on our website at
http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
This letter may not list all the violations in your product labeling or at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, you may find it useful to visit our website at http;//www.cfsan.fda.gov when reviewing your labels.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that corrections have been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
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