Public Health Service Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
June 21, 2016
WL # 32-16
Mr. Noah H. Sheray Popsalot, LLC 7723 Somerset Boulevard Paramount, CA 90723-4101
Dear Mr. Sheray:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 7723 Somerset Blvd., Paramount CA, from March 14-23, 2016. FDA investigators collected several samples of finished products and raw materials during the inspection. One of these samples, "Moroccan Mystique" gourmet flavored popcorn product was found to be in violation of the food labeling regulations, Title 21, Code of Federal Regulations, Part 101 [21 CFR Part 101], which causes this product to be misbranded within the meaning of Section 403 of the Act, [21 U.S.C. § 343]. You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
Your "Moroccan Mystique" gourmet flavored popcorn product is misbranded under section 403(a)(1) and 201(n) of the Act [21 U.S.C. 343(a)(1) and 21 U.S.C. 321(n)] because the label and labeling are false or misleading because your product bears the claim "gluten-free;" however, the food does not comply with the definition of "gluten-free" [21 CPR 101.91(a)]. Specifically, we analyzed your product and found greater than 20 ppm gluten. In addition, your website, www.popsalot.com which is referenced on your label also states that every Popaslot recipe is gluten-free. The unavoidable presence of gluten in the food that bears a gluten-free claim must be below 20 ppm gluten (i.e., below 20 mg gluten per kg of food) [21 CFR 101.91(a)(3)(i)(A)(3) or (a)(3)(i)(B) (ii)]. A food that bears the claim "gluten-free" in its labeling and fails to meet the requirements of paragraph 21 CFR 101.91(a)(3) will be deemed misbranded [21 CFR 101.91(b)].
This letter may not list all of the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110) and Food Labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
We also offer the following comments regarding your product:
• The number of Servings Per Container appears to be incQrrect. It is declared as "about 5"; however, if a bag contains 98g and a serving is 30g, then this would be approximately 3. [21 CFR 101.9(b)(8)] • The information panel contains the following intervening material [21 CFR 101.2(e)]:
o The allergen advisory statement appears between the nutrition information and the name and place of business of the manufacturer o The ingredient list contains "Non GMO" and " ."
• We note that the label bears an allergen advisory statement. We note that such statements must be truthful and not misleading and are not to be used in lieu of good manufacturing practices. • The statement for the place of business does not include the street address in accordance with 21 CFR 101.5(d). We note that the street address may be omitted if it is shown in a current city directory or telephone directory. • The homepage and FAQ page on the website states "trans fat free." Under section 403(r)(1)(A) of the Act, a nutrient content claim in food labeling must be made in accordance with a regulation authorizing the use of the claim in order for the food bearing such claim not to be misbranded. Although FDA has not defined the term "trans fat free" by regulation, we announced in the Federal Register dated July 11, 2003 [68 FR 41507 at 41509] that we would likely consider exercising enforcement discretion for a trans-fat nutrient content claim that is demonstrably true, balanced, adequately substantiated, and not misleading.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
Your response should be sent to U.S. Food and Drug Administration at the following address:
CAPT Lawrence Howell Acting Director, Compliance Branch U.S. Food and Drug Administration Los Angeles District 19701 Fairchild Road Irvine, CA 92612
If you have any questions with regard to this letter, please feel free to contact Compliance Officer Robert McNab at (949) 608-4409 or email email@example.com.
CDR Steven E. Porter, Jr. Los Angeles District Director
Cc: David M. Mazzera, Ph.D. Chief, Food and Drug Branch California Department of Public Health Food and Drug Branch 1500 Capitol Avenue, MS-7602 Sacramento, CA 95899-7413