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September 23, 2022

Warning Letter 633394

Dear Mr. Wollenberg:

The U.S. Food and Drug Administration (FDA) inspected your candy manufacturing facility, at the above-mentioned address, from March 11, 2022 to April 18, 2022. Your firm manufactures ready-to-eat (RTE) chocolate-covered candies which include nuts, pretzels, creams (variety of flavors), marshmallows, caramels, and peanut/pecan clusters. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we have determined that the candy products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].

Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products described below to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].

You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection, FDA investigators issued a Form FDA 483, Inspectional Observations, listing violations found at your firm. To date, we have not received a response from you regarding any corrective actions taken.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

1. Your hazard analysis did not identify and evaluate known or reasonably foreseeable hazards to determine whether the hazards require a preventive control, as required by 21 CFR 117.130(a)(1). Specifically, you did not identify and evaluate egg and wheat as allergen hazards to determine whether they require a preventive control. Your various hazard analyses covering candy products identify “cross-contamination” of peanut and tree nut allergens as a hazard requiring a preventive control. However, you manufacture various flavors of chocolate-covered cream centers that all contain egg, as well as chocolate-covered pretzels that contain wheat. You also manufacture other products that do not contain egg or wheat on shared equipment such as conveyor belts, which are food contact surfaces, on the same day. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls. Therefore, allergen cross-contact regarding egg and wheat is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify egg and wheat allergen cross-contact as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling, and use.

For example:

a. You did not evaluate the potential for allergen cross-contact when you manufacture different products on the same production line on the same day. You routinely manufacture cream center candies (egg), pretzels (wheat), caramels (neither wheat or egg), and marshmallows (neither wheat nor egg) on the same day without adequate cleaning of shared equipment, such as conveyor belts, in between these products with different allergenic profiles.

According to your production records, you enrobed the following products:
• (b)(4), Butter Creams (containing egg) then Chocolate Marshmallows (not containing Egg)
• (b)(4), Chocolate Pretzels (containing wheat) then Vanilla Creams (not containing wheat)
• (b)(4), Vanilla Creams (containing egg) then Vanilla Caramels (not containing egg)
• (b)(4), Raspberry Creams (containing egg) then Chocolate Pretzels (not containing egg)
• (b)(4), Chocolate Pretzels (containing wheat) followed by Brownie Creams (not containing wheat)
• (b)(4), Chocolate Pretzels (containing wheat) then Chocolate Marshmallows (not containing wheat)
• (b)(4), Cherry Creams (containing egg) then Chocolate Pretzels (not containing egg)
• (b)(4), Chocolate Pretzels (containing wheat) then Chocolate Marshmallows (not containing wheat)
• (b)(4), Lemon Creams (containing egg) then Chocolate Pretzels (not containing egg).

Your enrober supervisor explained that other than vacuuming the cloth belts (b)(4), no additional cleaning takes place for the cloth and white conveyor belts in between any product run in each day’s production on the enrober line.

Furthermore, you have no records showing cleaning was performed daily or between producing non-like allergen products on your enrober line, other than when the enrober is drained (b)(4), which occurred three times between October 26, 2021 and April 6, 2022.

b. You did not evaluate the potential for recirculating enrobing chocolate to become a vehicle for allergen cross-contact. On April 4, 2022, FDA Investigators observed particles of the cream centers (containing egg) break loose and fall into the chocolate bottomer and this chocolate was used to coat the bottom of Caramels (not containing egg) on April 5, 2022.

2. Your allergen controls procedures do not ensure protection of food from allergen cross-contact from walnuts, as required by 21 CFR 117.135(c)(2)(i). Your “Food Safety Plan for Chocolate Enrobing Department (April 2020)” identifies “Cross Contamination of Allergens (Peanuts & Tree Nuts)” as a hazard requiring a preventive control. Your allergen preventive control procedure states, “(b)(4).” However, your manufacturing sequencing does not account for products that contain walnuts, and you manufacture chocolate-covered Fudge Walnut, Maple Walnut, and Fruit and Nut (walnut) Eggs on shared equipment such as conveyor belts, which are food contact surfaces. Enrobing records indicate that you manufactured chocolate-covered Maple Walnut Eggs (b)(4), followed by chocolate-covered pretzels (no walnut) without cleaning in between products. Additionally, your procedures (e.g., “Food Safety Plan for Chocolate Enrobing Department (April 2020)” regarding allergen cross-contact do not include written corrective action procedures that must be taken if preventive controls are not properly implemented (see 21 CFR 117.150(a)).

3. You did not implement written procedures for environmental monitoring, as required by 21 CFR 117.165(b)(3). Specifically, you manufacture RTE chocolates that are exposed to the environment at the enrobing, cooling, and packaging steps. In your “Food Safety Plan for Wrapping & Packaging & Labeling of Finished Products (April 2020),” you identify recontamination with pathogens, specifically Salmonella, as a hazard requiring a preventive control. Your sanitation preventive control procedure requires environmental monitoring as verification and states, “Environmental swa[b] testing of (b)(4).” However, you did not implement this procedure as you only performed environmental monitoring once for the year 2021 (on May 24, 2021).

4. You did not establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which you have identified a hazard requiring a supply-chain-applied control, as required by 21 CFR. 117.405(a)(1). You identified Salmonella as a hazard “caused by contaminated product” (and thus requiring a preventive control) in your Food Safety Plan for Chocolate Enrobing Department (April 2020). However, you did not identify any supplier controls for Salmonella in chocolate among the preventive controls you apply for chocolate used for enrobing. Salmonella in chocolate is controlled during the manufacture of the chocolate; a knowledgeable person manufacturing/processing chocolate products would identify supplier controls for the hazard of Salmonella in chocolate. With regard to other hazards requiring a supply-chain applied control, we note that your Food Safety Plan for Wrapping & Packaging & Labeling of Finished Products (April 2020) identifies heavy metals and mycotoxins as hazards for chocolate, and your preventive control for these are COAs for each truckload of chocolate from your supplier (verified by lab testing (b)(4)). However, you did not approve your chocolate supplier in accordance with 21 CFR 117.410(d), and you have not established written procedures for the receipt of your chocolate ingredient, as required by 21 CFR 117.420 and 21 CFR 117.475.

Current Good Manufacturing Practice (Subpart B):

5. You did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically,

a. On April 1, 2022, an employee walked into the production area, handled paperwork, and then, without washing and sanitizing their hands, proceeded to straighten maple cream centers (b)(4), with bare hands, on the enrober line as they were being conveyed to the chocolate bottomer.

b. On April 4, 2022, while producing jersey creams on your enrober line, your enrober supervisor crawled under the conveyor belt on bare hands and knees to check the chocolate melter below the line. Then, without washing or sanitizing their hands, picked up 15 candies that were not completely covered in chocolate and, with bare hands, (b)(4) placed them back onto the conveyor belt before the enrober, to be processed back through the chocolate waterfall.

6. You did not take reasonable precautions and measures to ensure that eating food or chewing gum is confined to areas other than where food is exposed, as required by 21 CFR 117.10(b)(8). Specifically, on March 25, 2022, an employee was chewing gum while hand-forming the fruit and nut fudge filling for your 8 oz. Fruit and Nut Fudge Eggs. Your management stated that they had never heard chewing gum or eating during food production was not acceptable.

Misbranding:

Additionally, during this inspection, our investigators obtained product labeling and manufacturing records for several of your products that you sell in bulk to retail stores. We have reviewed the labeling and found the products you manufacture and distribute are misbranded within the meaning of Section 403 of the Act (21 U.S.C. § 343) as follows:

1. Your bulk Chocolate Coated Pretzels product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product case label fails to declare the major food allergen “wheat,” as required by section 403(w)(1) of the Act. The pretzels are made using wheat flour, but wheat is not listed on the case label.

2. Your bulk Milk Chocolate Red Raspberry Creams and bulk Milk Chocolate Maple Creams products are misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading. The case labels and the retail placard labels for the products fail to reveal the material fact that the identified flavors are artificially derived. As required by 21 CFR 101.22(i)(2), when a food contains any artificial flavor which simulates, resembles or reinforces the characterizing flavor, the name of the food on the principal display panel or panels of the label shall be accompanied by the common or usual name(s) of the characterizing flavor, in letters not less than one-half the height of the letters used in the name of the food and the name of the characterizing flavor shall be accompanied by the word(s) “artificial” or “artificially flavored,” in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., “artificial vanilla,” “artificially flavored strawberry,” or “grape artificially flavored.”

3. Your bulk Milk Chocolate Red Raspberry Creams, bulk Milk Chocolate Maple Creams, and bulk Chocolate Coated Pretzels products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4. For example:

a. Your bulk Milk Chocolate Red Raspberry Creams product is manufactured using raspberry puree; however, you fail to list the puree or all of its sub-ingredients on your finished product case label. Further, the retail placard label fails to list the artificial raspberry flavor used in the product and lists red raspberries instead of the raspberry puree and its complete sub-ingredients including corn syrup, sugar, water, dextrose, carrageenan gum, and the color red 40. The placard label also lists wheat, which is not an ingredient in the product.

b. The case labels and retail placard labels for your bulk Milk Chocolate Red Raspberry Creams, bulk Milk Chocolate Maple Creams, and bulk Chocolate Coated Pretzels products fail to list the correct ingredients for the chocolate coating used, in that the coating’s butterfat, whey powder, and lactose ingredients are not declared. Further, the labels list ingredients for the chocolate coating that are not in the coating, such as milk.

c. The case label for your Chocolate Coated Pretzels fails to list the sub-ingredients of the pretzels, including wheat flour. The retail placard labels for your Chocolate Coated Pretzels lists ingredients that are not present in the product, such as egg whites and sodium bicarbonate.

d. The case label bears the statement, “The candy may contain one or more of the following ingredients.” The following are examples of ingredients that are declared on the product labels that are not in that specific product:

    i. Milk Chocolate Red Raspberry Creams: lists wheat, which is not an ingredient in the product.

    ii. Milk Chocolate Red Raspberry Creams, bulk Milk Chocolate Maple Creams, and bulk Chocolate Coated Pretzels products: the labels list ingredients for the chocolate coating that are not in the coating, such as milk.

    iii. Chocolate Coated Pretzels (retail placard labels): lists ingredients that are not present in the product, such as egg whites and sodium bicarbonate.

    iv. The case labels for your bulk Milk Chocolate Red Raspberry Creams, bulk Milk Chocolate Maple Creams, and bulk Chocolate Pretzels products list numerous ingredients that are not present in the products, including, but not limited to, semi-sweet chocolate and its sub-ingredients, confectionary coating and its sub-ingredients, walnuts, peanuts, almonds, pecans, raisins, coconut, cream butter, and cherries.

When designing labels that are suitable for more than one similar product or for use on packages of assortments, see CPG Sec. 505.100 Bakery Products, Candy - "Catch-All" or "Shotgun" Ingredients at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074420.htm.

4. Your bulk Milk Chocolate Red Raspberry Creams and bulk Milk Chocolate Maple Creams products are misbranded within the meaning of section 403(i)(1) of the Act [21U.S.C. §343(i)(1)] in that the product case labels fails to bear the common or usual name of the food. The Milk Chocolate Red Raspberry Creams case label lists “L Raspberry” and the Milk Chocolate Maple Creams case label lists “L Maple” as the statements of identity, which are not in accordance with 21 CFR 101.3.

5. Your Milk Chocolate Raspberry Creams product is misbranded under section 403(k) of the Act because the product contains an artificial coloring, flavoring, or a chemical preservative but does not bear labeling stating that fact. Specifically:

  a. Your firm provides placard labels to your retail customers to be used on their bulk retail displays. FD&C Red No. 40 is an ingredient in the raspberry puree used in the Milk Chocolate Raspberry Creams product but is not declared by its listed name or an appropriate abbreviation on the placard label for the product, as required under 21 CFR 101.22(k).
  b. The retail placard label for the Raspberry Cream product fails to declare the preservatives, sodium benzoate and potassium sorbate, which are ingredients in the raspberry puree ingredient, as well as flavors such as artificial red raspberry flavor.
  c. The case labels list numerous preservatives. However, their function is not declared in accordance with 21 CFR 101.22(j).

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We have the following comments regarding your labels:

Please note that the nutrition labeling exemptions found in 21 CFR 101.9(j)(1) and 21 CFR 101.36(h)(1) apply to retailers with annual gross sales of not more than $500,000, or with annual gross sales of foods or dietary supplements to consumers of not more than $50,000. For these exemptions, a notice does not need to be filed with the Food and Drug Administration (FDA).

Or, if your firm employs fewer than an average of 100 full-time equivalent employees and sells fewer than 100,000 units of that product in the United States in a 12-month period then your firm may qualify for the nutrition labeling exemption for low-volume products under 21 CFR 101.9(j)(18).

We recommend you review the above nutrition labeling exemptions to see if your firm qualifies for the exemption, then review https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-business-nutrition-labeling-exemption-guidance for information on filing for an annual exemption. The application may be submitted online at: https://www.cfsanappsexternal.fda.gov/scripts/NLE/client/login.cfm

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to Stephen Rabe, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or to U.S. Food and Drug Administration, 550 Main Street, Suite 4-930, Cincinnati, OH 45202. If you have any questions about the content of this letter, you may contact Stephen Rabe at 513-322-0660.

Sincerely,
/S/
Steven B. Barber, Division Director
Office of Human and Animal Foods Operations-East 5