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  5. Deggeh Foods, Inc. - 628460 - 07/29/2022
  1. Warning Letters

WARNING LETTER

Deggeh Foods, Inc. MARCS-CMS 628460 —

Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Ahmed T. Koita
Recipient Title
Owner
Deggeh Foods, Inc.

363 E 169th St
Bronx, NY 10456-1710
United States

sales@deggeh.com
Issuing Office:
Office of Human and Animal Food Operations East – Division 1

United States

WARNING LETTER
CMS # 628460

July 29, 2022

Dear Mr. Koita:

The U.S. Food and Drug Administration (FDA) inspected your facility located at 363 E 169th St, Bronx, New York from November 29, 2021 to January 10, 2022. Based on our inspection and subsequent review of product labeling collected during the inspection, your firm’s website at the Internet address https://deggeh.com/, and your Facebook social media page at https://www.facebook.com/pages/ category /Community/Deggeh-products-Natural-Organic-products-made-in-Gambia-564035160361406/, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New Drugs and Misbranded Drugs

FDA reviewed your website at the Internet address https://deggeh.com in June 2022 and has determined that you take orders there for your products Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, and Moringa Tea Bags. We also reviewed your Facebook social media page at https://www.facebook.com/pages/ category /Community/Deggeh-products-Natural-Organic-products-made-in-Gambia-564035160361406/, which directs consumers to your website to purchase your products. The claims on your website, Facebook page, and product labels establish that your Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, and Moringa Tea Bags products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

Actibest® Health Plus Capsules

Product Label:

  • “Instant Relief Fortified Herbal Formula for High Blood, Cholesterol, Asthma, Cancer Arthritis, Depression, Migrains [sic], Sickle Cell Kidney Problems Liver Problems . . . Diabetes, Rheumatism, Insomnia, Circulation Problems Hermoroids [sic], Acid reflux, Gastric Ulcers”

Facebook Post dated October 14, 2019:

  • “Actibest…Fast, Instant relief for: •Diabetes •Blood Pressure…•Hepatitis •Arthritis…•Constipation…•Hemorrhoids…•Migraines…•Cancer •Insomnia •Stroke • Asthma…•Acid Reflux…•Kidney Problems…•Joints, Back Pain”

StomacAID Capsules

Product Label and Image of Product Label on Deggeh Website:

  • “Prevention and Relief for Gastric Ulcers, Acid Reflux . . . Indigestion . . . Food Poisoning Stomach Worms & Parasites”

Best Hemorrhoids Rapid Action Herbal Healing Formula

Product Label:

  • “Best Hemorrhoids Rapid Action Herbal Healing Formula”

Moringa Tea Bags

Product Label:

  • “Get almost instant results and relief for: MIGRAINS [sic], HIGHBLOOD [sic] PRESSURE, HIGH SUGAR, DIABETES, HIGH CHOLESTEROL . . . INSOMNIA . . . SICKLE CELL, ASTHMA, RHEUMATISM, ARTHRITIS, LIVER AND KIDNEY DISEASE.”
  • “SOOTHING MORINGA TEA . . . HELPS PREVENT CANCER, DESTROYS EARLY CANCEROUS CELLS”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Actibest® Health Plus Capsules, StomachAID capsules, and Moringa Tea Bags are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Actibest® Health Plus Capsules, StomachAID capsules, and Moringa Tea Bags fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

Adulterated Dietary Supplements

The facility inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Thus, even if your Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomachAID capsules products were not unapproved new drugs and misbranded drugs, these products would be adulterated dietary supplements under section 402(g)(1) of the Act.

The violations include the following:

1. You failed to establish the following specifications as required by 21 CFR 111.70:

  • Specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order when you receive a product from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) (21 CFR 111.70(f)).
  • Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure the specified packaging is used with the specified label (21 CFR 111.70(g)).

Specifically, you did not establish these specifications for your Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomachAID capsules dietary supplement products.

We received your March 20, 2022, response. However, you did not provide any of the required specifications noted above.

2. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, you did not provide any written procedures for quality control operations. We received your March 20, 2022 response, in which you said, “quality control procedures forms now available and will be applied on all future products.” However, your response did not include any written quality control procedures or other evidence of any implemented corrective actions.

During the inspection, you told our investigator that you are President and the most responsible person for Deggeh Foods, Inc. as well as Deggeh Foods International in Gambia, Africa. You also indicated that you make quality decisions and evaluations. You stated that the dietary supplements distributed by Deggeh Foods, Inc. are manufactured at the Gambia, Africa facility of Deggeh Foods International. Our inspection found that such products are packaged and labeled at your Bronx facility of Deggeh Foods, Inc. You also stated that the two firms operate as two separate entities.

To the extent that you contract with other firms to manufacture your product that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement cGMP requirements. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement cGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). Quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, quality control must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)).

3. You must establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Although your March 20, 2022 response included written procedures regarding product complaints, your written procedures for product complaints do not include all procedures needed to fulfill the requirements related to the review and investigation of a product complaint.

Specifically, your product complaint procedures lack procedures for a qualified person to review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR Part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; and investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury.

4. You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you did not have written procedures for your packaging and labeling operations. Further, you did not meet the requirements that apply to packaging and labels under 21 CFR 111.410. Specifically, you failed to meet the requirements of 21 CFR 111.410(d), which provides that you must be able to determine the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution. Although you apply labels to your dietary supplement products, you do not include a lot number or other unique identifier. A lot number or other unique identifier is necessary to determine the complete manufacturing history and control of your dietary supplements.

We received your March 20, 2022, response. Your response did not include evidence of any implemented corrective actions or written procedures for your packaging and labeling operations.

5. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you did not have written procedures for your holding and distributing operations. In addition, you failed to meet the requirement to hold dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the dietary supplements are not affected, as required by 21 CFR 111.455(a). Specifically, our investigators noted that you do not monitor the temperature and humidity of the facility, including the warehouse where dietary supplements are stored.

We received your response on March 20, 2022. Your response did not include evidence of any implemented corrective actions or written holding and distributing procedures reportedly now in use.

6. You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, including the procedures for conducting a material review and making a disposition decision, in accordance with 21 CFR 111.503.

We received your response on March 20, 2022, in which you said, “procedures for returned dietary supplements are now established” and included a written document called, “Goods Return Form.” However, this document does not demonstrate that you have taken corrective action to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements. The “Goods Return Form” appears to be a form for customers to fill out when returning goods; it does not include any procedures that you will follow to fulfill the requirements that apply to returned supplements, as required by 21 CFR 111.503. For example, the “Goods Return Form” lacks the required procedures to identify and quarantine returned dietary supplements until quality control personnel conducts a material review and makes a disposition decision, as required by 21 CFR 111.503.

Once you have established such written procedures, you must also make and keep records of your compliance with such requirements for returned dietary supplements, in accordance with 21 CFR 111.535(b).

7. You failed to establish and follow written procedures for cleaning the physical plant and grounds and for pest control, as required by 21 CFR 111.16. Specifically, you did not have such written procedures. Once you establish the required procedures, you must make and keep records of such procedures, as required by 21 CFR 111.23(b). Likewise, you failed to establish and follow written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to package, label, or hold your dietary supplements, as required by 21 CFR 111.25(c). For example, you package an allergen, peanut powder, in the same process area used to package your other products, including dietary supplement products, which do not contain peanuts. You were unable to provide cleaning or sanitation procedures or monitoring documents to ensure that there was no cross-contamination with the peanut products. Once you establish the required procedures, you must make and keep records of such procedures, as required by 21 CFR 111.35(b)(1)(iii).

Misbranded Dietary Supplements

In addition, even if your StomacAID Capsules, Actibest® Health Plus Capsules, and Best Hemorrhoids Rapid Action Herbal Healing Formula products were not unapproved new and misbranded drugs, these products would be misbranded under section 403 of the Act because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:

1. Your StomacAID Capsules, Actibest® Health Plus Capsules, and Best Hemorrhoids Rapid Action Herbal Healing Formula are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. For example:

  • Your StomacAID capsules product label fails to present the nutrition information in the form of a supplement facts label as required by 21 CFR 101.36.
  • Your Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula product labels fail to list riboflavin and magnesium in the correct order. Riboflavin should be listed after thiamin and magnesium should be listed after iron in accordance with 21 CFR 101.36(b)(2)(i)(B).
  • Your Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula product labels bear an incorrect %DV for vitamin C, vitamin E, niacin, calcium, iron, sodium, and magnesium based on the quantitative amount declared per serving. For dietary ingredients for which DRV's have been established, "Less than 1%" or "<1%" shall be used to declare the "% Daily Value" when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the "% Daily Value" when rounded to the nearest percent is zero. Furthermore, the label fails to express each percent DV to the nearest whole percent as required by 21 CFR 101.36(b)(2)(iii)(C).
  • Your Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula product labels bear a symbol beside each (b)(3)-dietary ingredient’s quantitative amount but fail to place the same symbol at the bottom of the nutrition label and followed by the statement "Daily Value not established," as required by 21 CFR 101.36(b)(3)(iv). Furthermore, these labels declare total fat, total carbohydrate, dietary fiber, and protein but fail to place a symbol that refers to the statement "Percent Daily Values are based on a 2,000 calorie diet" at the bottom of the nutrition label, as required by 21 CFR 101.36(b)(2)(iii)(D).

2. Your products Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the product labels fail to include an accurate serving size in accordance with 21 CFR 101.36(b). The “SUPPLEMENT FACTS” label for Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula relays “Serving Size – one tablespoon,” but this product is in capsule form.

3. Your Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to present the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7. The Actibest® Health Plus Capsules label declares the quantity as only “Qty. 30.” The labels must declare the quantity and the units, such as “30 capsules”, presented on the principal display panel.

4. Your Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomacAID Capsules products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that these product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically:

  • These products are encapsulated but the labels fail to declare the capsule ingredients in the ingredients statement. Furthermore, the ingredients statement must be placed below or immediately contiguous and to the right of the Supplement Facts label in accordance with 21 CFR 101.4(g).
  • Your Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomacAID Capsules declare moringa, but fails to declare the standardized common name, horseradish tree, that is listed in the reference Herbs of Commerce.
  • Your Actibest® Health Plus Capsules product label declares the ingredient trigonella foenum-graecum, but fails to declare the standardized common name, fenugreek.

5. Your products Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomacAID Capsules are misbranded within the meaning of section 403(s)(2)(A) of the FD&C Act [21 U.S.C. §343(s)(2)(A)] in that their labels fail to list the name of each ingredient of the proprietary blends in accordance with 21 CFR 101.36(c). Further, your label fails to list the total weight of all dietary ingredients contained in the proprietary blends in a Supplement Facts label in accordance with 21 CFR 101.36(c)(3).

6. Your Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomacAID Capsules products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because their labels do not include a statement of identity as a “dietary supplement” or an appropriately descriptive term indicating the type of dietary ingredients that are in the product, as required by 21 CFR 101.3(g). Furthermore, your Actibest® Health Plus Capsules product label fails to present the statement of identity on the principal display panel as required by 21 CFR 101.3(d).

7. Your Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomacAID Capsules products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that their labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

8. Your Best Hemorrhoids Rapid Action Herbal Healing Formula product is misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the label fails to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii).

9. Your Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, and StomacAID Capsules products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).

10. Your Actibest® Health Plus Capsules and StomacAID Capsules products are misbranded within the meaning of Section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim; and the claim includes a mandatory disclaimer.

11. Your Best Hemorrhoids Rapid Action Herbal Healing Formula product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.

Misbranded Conventional Foods

Furthermore, even if your Moringa Tea Bags product was not an unapproved new and misbranded drug, the product would be misbranded under section 403 of the Act because it does not comply with the labeling requirements for conventional foods. Specifically, we identified the following:

1. Your product Moringa Tea Bags is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the labeling bears nutrient content claims, but the product does not meet the requirements to bear the claims. Your product’s label compares the nutrient content of Moringa Tea Bags to nutrients in other foods:

  • “15 Times The Potassium Bananas”
  • “12 Times the Vitamin C in Oranges”
  • “25 Times The Iron In Spinach”
  • “17 Times the Calcium in Milk”
  • “4 Times The Vitamin A In Carrots”

These are considered “relative claims” in that the statements compare the level of a nutrient in the food with the level of a nutrient in a reference food (21 CFR 101.13(j)). When labeling bears a relative claim, the labeling must bear, among other information, clear and concise quantitative information comparing the amount of the subject nutrient in the product per labeled serving with that in the reference food, in accordance with 21 CFR 101.13(j)(2)(iv)(A). Your product makes nutrient content claims that are relative claims, but the labeling fails to bear the quantitative amounts of the subject nutrient in the products in comparison to the reference food.

2. Your product Moringa Tea Bags is misbranded within the meaning of section 403(q) of the Act (21 U.S.C. 343(q)) since it’s label fails to present nutrition information in accordance with 21 CFR 101.9. Specifically, the nutrition information is declared using a Supplement Facts label.

3. Your product Moringa Tea Bags is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size on the label is incorrect. The serving size for tea, flavored and unsweetened, is 12 fl oz (360 mL) as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The nutritional information for MORINGA TEA BAGS states the serving size as “Serving size 2 Capsules,” but this product is in tea bag form.

4. Your product Moringa Tea Bags is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product label does not include the name and place of business as required by 21 CFR 101.5. The label only bears the web address, phone number, and email address on the principal display panel (PDP).

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 also offer the following comments:

1. Your Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula products’ Supplement Facts label incorrectly presents protein indented under total carbohydrate and the label fails to indent zeaxanthin and lutein under total carotenoids.

2. Your Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula product labels appear to declare percent DVs based on daily values in use prior to the nutrition labeling regulations which became effective July 26, 2016. The compliance date for the revised labeling regulations was January 1, 2021. When making revisions to your products’ Supplement Facts label, you must comply with the revised labeling regulations.

3. Your Actibest® Health Plus Capsules product label’s information panel includes nutrition and ingredient information intermingled with information that is considered intervening material. Examples of intervening material are the expiration date, structure/function claims, and statements about side effects, chemicals, and additives. All information appearing on the information panel of the product label should appear in one place without other intervening material. [21 CFR 101.2(e)].

4. The placement of heavy bars on your Actibest® Health Plus Capsules and Best Hemorrhoids Rapid Action Herbal Healing Formula products’ Supplement Facts label is not in accordance with 21 CFR 101.36(e)(6).

5. The net quantity of contents statement “25 Herbal Tea Bags” is on the information panel of your Moringa Tea Bag product, and not on the principal display panel (PDP) as required by 21 CFR 101.7(a).

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 the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433 or via email at Lillian.aveta@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or email at Lillian.aveta@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1

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