Inspections, Compliance, Enforcement, and Criminal Investigations
Sundial Herbal Products 5/24/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Ave.Jamaica, NY 11433
May 24, 2013
Sundial Herbal Products
ATTN: Mr. Adoni-iah Hakim, Owner
3609 Boston Road
Bronx, NY 10466-5810
Dear Mr. Hakim:
On October 4th though November 15th 2012, the U.S. Food and Drug Administration (FDA) inspected your facility located at 3609 Boston Road, Bronx, New York. You informed the investigator that your firm is an herbal supplement manufacturer. During the inspection, FDA found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
The inspection revealed the following significant violations:
Unapproved New Drugs
During the inspection of your facility, we collected labeling for your products. We have determined that your Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims in the labeling for these products establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on the labels for your products include the following:
Woman Back Tonic
- “Helps to break up abnormal growths, cysts & fibroids...”
- “…For people on The Run Who Don’t Need The Runs.”
- In Spanish: “para libara el estomago y los intestinos de gases y desperdicios, como lombrices y parasitos y sanar las ulceras, hemorroides y library el cancer del estomago y los intestinos.” (English translation) “To release the stomach and intestines and waste gases such as worms and parasites and heal ulcers, hemorrhoids and rid the cancer of the stomach and intestines.”
Wood and Root Tonic
- In Spanish: “limpia…la congestion de asthma y la gripe.” (English translation) “clean…congestion of asthma and flu.”
The name of the following products is in itself a disease claim:
- Flu-Allergy Hayfever
- Worms & Parasites
Your Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites 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)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, because your Koromantee, Wood and Root Tonic, Asthma, Diabetics, and Hepatitis/Liver products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Therefore, these products are also misbranded under section 502(f)(1) of the Act in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Dietary Supplement CGMP Violations
In addition, even if your Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites products were not unapproved new drugs, they would be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)], as would your Blood Pressure, African Manback Tonic, Heart, Nerve Tonic, Sundial Ashanti Weight Loss Energy Lifter and Appetite Suppresser products, in that these products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
Specifically, during the inspection, investigators observed the following violations:
- You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Additionally, you have not filed nor have you received approval of a petition exempting you from this requirement, as provided in 21 CFR 111.75(a)(1)(ii). Specifically, you do not sample your incoming dietary ingredients nor subject them to any testing or examination to confirm their identity prior to using them in the manufacture of your dietary supplement products.
- You failed to establish product specifications for the identity, purity, strength, and composition of the finished batches of dietary supplements you manufacture, as required by 21 CFR 111.70(e). Specifically, you stated during the inspection that you have not established finished product specifications for any of the dietary supplements you manufacture.
- You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205(a). Specifically, you indicated during the inspection that you do not have written master manufacturing records for any of your dietary supplement products.
- You did not prepare a complete batch production record (BPR) every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, you indicated during the inspection that you have not maintained batch records since March 27, 2012. The batch records that you had maintained prior to that date were incomplete in that they were missing much of the information required by 21 CFR 111.260; for example, the batch records you provided to our investigator lacked basic information such as the identity and weight or measure of each component used, as required under 21 CFR 111.260(b). Your batch production records must include complete information relating to the production and control of each batch, in accordance with 21 CFR 111.255(b) and 111.260.
- You did not make and keep written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Specifically, you indicated during the inspection that you do not have written quality control procedures.
Furthermore, you did not implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing your dietary supplements to ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as specified in a master manufacturing record, as required by 21 CFR 111.65.
- You did not make and keep written procedures for the review and investigation of product complaints, as required by 21 CFR 111.570(b)(1), nor did you make and keep a written record of every product complaint that is related to good manufacturing practice, as required by 21 CFR 111.570(b)(2). Specifically, you received at least one complaint regarding an off-taste product that you described during the inspection. You concluded that the product had fermented; however, you did not keep a record of the complaint or follow-up review and investigation.
- Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated, as required by 21 CFR 111.27(a)(3)(v). Specifically, the oak barrels used to hold tonic components and finished products are not dedicated for storing particular components or tonics, and cannot be sanitized between uses; this creates the potential for components and/or finished dietary supplement products to become contaminated with prior contents and/or microorganisms.
Misbranded Dietary Supplements
Further, even if the labeling for your Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites products did not contain claims that cause them to be unapproved new drugs, they would still be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343], as are your Blood Pressure, African Manback Tonic, Heart, Nerve Tonic, Sundial Ashanti Weight Loss Energy Lifter and Appetite Suppresser products in that the labeling for these products does not comply with the food labeling requirements in 21 CFR Part 101, as follows:
Your Arthritis, Asthma, Blood Pressure, Diabetics, Flu-Allergies HayFever, Heart, Hepatitis/Liver, Nerve Tonic, Worms & Parasites, Sundial Ashanti Weight Loss Energy Lifter and Appetite Suppresser, Woman Back Tonic, Koromantee, African ManBack Tonic, and Wood and Root Tonic products 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 labels fail to bear nutrition labeling (“Supplement Facts” panel), as required by 21 CFR 101.36.
Your African ManBack Tonic and Diabetics products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C § 343(i)(2)] because they contain dietary ingredients that are not declared on the label, as required by 21 CFR 101.36(b)(3). Specifically, you indicated during the inspection that not all of the ingredients are always declared on the label. For example,
- The ingredients declared on African ManBack Tonic are Essor Wisa, Pina-de-ration, and Khoya Senegalensis, but you indicated in a written statement that ManBack Tonic also contains ginger, cayenne pepper, cinnamon and cloves in addition to the herbs declared.
- The herbal blend Diabetics declares Wild Tropical Herbs as an ingredient. You indicated in a written statement that this is not a specific ingredient, but means a blend of herbs not specifically named.
- You indicated in a written statement that there may be some variety in the herbal ingredients used, that due to seasonal availability of some herbs, you sometimes substitute guava leaf (Psidium Guajava) with neasberry leaf (Manikara Zapota) in the Diabetics herbal blend because they have similar effects on the body. However, this is not reflected on the product label.
Your Arthritis, Asthma, Blood Pressure, Diabetics, Flu-Allergies HayFever, Heart, Hepatitis/Liver, Nerve Tonic, Worms & Parasites, Sundial Ashanti Weight Loss Energy Lifter and Appetite Suppresser, Woman Back Tonic, Koromantee, African ManBack Tonic, and Wood and Root Tonic dietary supplement products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. 403(s)(2)(B)] because the labels fail to identify the products using the term dietary supplement [21 CFR 101.3(g)].
The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction.
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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)). 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.
Please send your reply to the Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, NY 14202, Attention: Patricia A. Clark, Compliance Officer. If you have questions regarding any issues in this letter, please contact Ms. Clark at 716-846-6236.
Ronald M. Pace
New York District