- Black Market Hot Sauce Company
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
May 22, 2015
In reply refer to Warning Letter SEA 15-16
Daniel J. Pike, Owner
Black Market Hot Sauce Company
3262 S. Pass Road
Everson, Washington 98247
On October 2 and 6, 2014, the U.S. Food and Drug Administration (FDA) conducted an inspection of your firm located at 3262 S. Pass Road, Everson, Washington. Our inspection found significant violations of the food labeling regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). During this inspection, the FDA collected a sample of your Black Market Hot Sauce Cambodian Blend. An analysis of the collected sample and a review of your product labeling demonstrate that your Black Market Hot Sauce Cambodian Blend product is misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act or FD&C Act) [21 U.S.C. § 343]. You may find the Act and the referenced CFR regulations through links on FDA’s internet home page at www.fda.gov.
Food Misbranding Violations
1. Your Black Market Hot Sauce Cambodian Blend product is misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading. Specifically:
- The vitamin C content is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)]. The product declares the daily value for vitamin C at 20%; however, FDA scientists concluded that the daily value of vitamin C in the product is 2.3% (original) and 1.65% (check) of the declared amount.
- The product label bears the statement “Black Market Hot Sauce’s Cambodian Blend is fermented rather than cooked, making it a fully raw product full of healthy probiotics...” Based on the manufacturing procedure that you described to our investigator and that our investigator observed, the product is heated (cooked) at (b)(4)°F for (b)(4) minutes. As such, the product is no longer raw, and therefore it is misleading to state that it is a raw product. You acknowledged to our investigator that this statement should not be on the label, since you changed your process two years ago to include a heat step.
Additionally, in light of the heat step, it is unlikely that the finished product contains a significant number of probiotics. You told our investigator that you have not had the product tested for the presence of probiotics.
2. Your Black Market Hot Sauce Cambodian Blend product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format. For example:
- The serving size of “2 tbsp” is not based on an appropriate “reference amount customarily consumed” (RACC) for this type of product. The Reference Amount Customarily Consumed is “1 tsp (5 ml).” Therefore, all nutrient amounts are incorrectly declared as required by 21 CFR 101.9(c).
- The household measure followed by the equivalent metric quantity in parenthesis is not provided for the serving size in accordance with 21 CFR 101.9(b)(7).
- The product label declares % Daily Values for both Trans Fat and Sugars, however, in accordance with 21 CFR 101.9(c)(2) and 21 CFR 101.9(c)(6), there is no % Daily Value established for either Trans Fat or Sugars.
- The quantitative amount by weight is not declared for Total Fat as required by 21 CFR 101.9(d)(7).
- The % Daily Value for iron is not rounded in accordance with 21 CFR 101.9(c)(8)(iii).
- The order of nutrients is incorrect in that the declaration for sugar content should appear below the declaration for fiber content as required by 21 CFR 101.9(c).
- The ingredient statement appears within the Nutrition Facts box, which is not the correct format. The regulations under 21 CFR 101.9 do not provide for the ingredients statement to be declared within the Nutrition Facts label.
- Your label does not display the required bars that separate: the “Amount Per Serving” subheading from the serving size information as required in 21 CFR 101.9(d)(4), the column heading “% Daily Value,” followed by an asterisk (e.g., “% Daily Value*”) from information on calories as required in 21 CFR 101.9(d)(6), and the nutrient information for vitamins and minerals from information on other nutrients as required by 21 CFR 101.9(d)(8).
3. Your Black Market Hot Sauce product is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients, but the labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4. Specifically:
- Your ingredient statement does not list the ingredients in descending order of predominance by weight as required by 21 CFR 101.4(a). For example, the order of the first two ingredients (i.e., “Jalapenos, vinegar”) should be reversed.
- The ingredients statement declares “Origanox”; however, this ingredient is not present in the product. During the inspection, our investigator observed the manufacturing of the Cambodian blend hot sauce and this ingredient was not added to the product. Furthermore, “Origanox” is not the common or usual name of an ingredient.
We received, on October 15, 2014, your written response to the Form FDA 483, Inspectional Observations, issued to you at the conclusion of the inspection. In your response, you acknowledged that your labels need correction, but we did not receive the new labeling. You estimated it may take up to a year to correct your labels. This time frame to correct your labeling violations is not adequate. Please provide FDA with examples of corrected labeling, as soon as they become available.
The above is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that all of your products are in compliance with applicable statutes and regulations enforced by the FDA. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent to Maria P. Kelly-Doggett, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Maria Kelly-Doggett at 425-302-0427.
Miriam R. Burbach
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560