Inspections, Compliance, Enforcement, and Criminal Investigations

Black Seed Herb, Inc. 7/11/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food Operations East
Division 1

 

WARNING LETTER
CMS #515581
 
July 11, 2017
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Abdelaziz Benedim, CEO
Black Seed Herb, Inc.
17 Oberfest Street
Liberty, NY 12754
 
Dear Mr. Benedim:
 
 
The U.S. Food and Drug Administration conducted an inspection of your facility located at 17 Oberfest Street, Liberty, NY 12754 from August 30, 2016 through September 21, 2016.  Based on our inspection, we identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products, including but not limited to Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules, Black Seed w/ Olive Leaf/Garlic Capsules, Black Seed Honey Booster, Sweet Excitement Her Honey, Revive Honey Herbal Elixir, Flax Seed Oil, Black Seed Oil, and Black Cumin Seed Oil, to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements found under 21 CFR Part 111.
 
Additionally, we reviewed your website at the Internet address http://www.myblackseed.com in April 2017 and determined that you take orders there for the products Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules, and Black Seed w/ Olive Leaf/Garlic Capsules. The claims on your website and on the product labels that we collected during the inspection establish that these 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.
 
Further, we have reviewed the labels used on several of your products and have identified significant violations causing the products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343).
 
You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
 
We received your response, dated October 5, 2016, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm on September 21, 2016. We address this response below, in relation to each of the noted violations.
 
The violations are described below.
 
Unapproved New Drug and Misbranded Drug Violations
 
As discussed above, FDA reviewed your product labels obtained during the inspection and your website at the Internet address http://www.myblackseed.com in April 2017 and determined that you take orders on your website for the products Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules and Black Seed w/ Olive Leaf/Garlic Capsules. The claims in your product labels and on your website establish that these 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 claims on your website http://www.myblackseed.com and/or product labels that provide evidence that your products are intended for use as drugs include:
 
1.    Diabalance Herbal Blood Sugar Balance- 90 Tablets
 
•(Web) “The main focus of the herbs within Diabalance is blood sugar balancing…”
 
•(Web) “If the pancreas does not metabolize and use sugar in the body properly, a diabetic disease can soon develop…can aid the protection of future pancreatic problems. SweetSunnah inc, (sic) proudly offers this time herbal formula for the natural control of blood sugar levels...”
 
•(Web) “Research studies in the United States and abroad have found that improved blood sugar control benefits people with either type 1 or type 2 diabetes...”
 
•(Product Label)  “If the pancreas does not metabolize and use sugar in the body properly, a diabetic disease can soon develop…can aid the protection of future pancreatic problems. Black Seed Herb, Inc. proudly offers this herbal formula for the natural control of blood sugar levels. Set your body in balance and supplement a balanced diet with our new anti-diabetic formula. DIABALANCE…”
 
2.    Quick Slim with pure Hoodia Gordonii - 60 Caps 
 
•(Web) “Sweet Sunnah QuickSlim is an all-natural formula that…attacks obesity…”
 
3.   BHealthy Black Seed Bitter Melon 90 Veggie Caps
 
•(Web) “Bitter Melon & Black Seed Capsules . Maintains Healthy Blood Sugar Levels*. Black Seed is combined with this bitter fruit to gain the most benefit from its blood-sugar-controlling ability*.Bitter Melon has a long history of medicinal use in the indigenous traditions of Africa, Asia and the Amazon as well…”
 
•(Web) “Clinical research has shown that Bitter Melon has blood-sugar lowering effects *and other properties of potential benefit against diabetes mellitus. Other studies have also shown Bitter Melon to have antiviral, anti-tumour (sic), and cholesterol-lowering effects...”
 
•(Product Label) “Sweet Sunnah Bhealthy Blood Sugar Black Seed with Bitter Melon is an amazing botanical that acts as a mediator between the body’s cell and insulin thereby decreasing resistance to proper insulin function. This unique formula may block excessive formulation of glucose in the blood and enhance tolerance for blood sugars…”
 
4.    Black Seed w/ Olive Leaf/Garlic- 90 Caps
 
•(Web) “Garlic is an antifungal. It is an antibacterial. It lowers blood pressure. It lowers cholesterol. It may have a positive effect on impotence…It helps to shorten a cold and prevent coughs...It has been shown to be effective in treating certain cancers…”
 
•(Web) “Extensive research showed that garlic had antibacterial, antimicrobial (Candida Albicans (yeast infection) activity…”
 
•(Web) “There are many well designed studies that have been published in legitimate journals that state garlic has a distinct effect on the reduction of cholesterol…”
 
•(Web) “New Studies in the UK are showing that garlic can be beneficial…can reduce the risk of pre-eclampsia…And even more recently the medical journal ‘Antimicrobial Agents and Chemotherapy’ confirmed that garlic has chemotherapeutic effects…”
 
•(Web) “The oleuropein in olive leaf is a natural wide-spectrum antibiotic, anti-bacterial, anti-viral, and anti-fungal. Unlike synthetic antibiotics, it destroys only the bad bacteria and protects the good...”
 
•(Web) “Olive Leaf does not cure diseases, it is however a cold blooded killer of most pathogens...”
 
•(Web) “It has proven to be useful in cases of yeast and fungal infections, herpes, chronic fatigue, allergies, psoriasis and many other pathogens. Since it works like a broad-spectrum antibiotic, it is useful against colds, flu, and upper respiratory and sinus infections. In addition, it has been shown to lower blood sugar, normalize arrhythmias, inhibit oxidation of LDL (the bad cholesterol), and relax arterial walls, thereby helping to lower blood pressure…It is also effective at inhibiting LDL oxidation associated with atherosclerosis...”
 
•(Web) “[F]amous Greek physician Dioscorides used black seeds to treat headaches and toothaches…”
 
•(Web) “Chemical analysis has further revealed that the black seed contains carotene, which is converted by the liver into vitamin A, the vitamin known for its anti-cancer activity…”
 
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)]. 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, Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules and Black Seed w/ Olive Leaf/Garlic Capsules are intended for treatment of one or more diseases that are not amenable to self-diagnosis 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, these products 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)].
 
Although violations associated with your labels and website were discussed during the inspection, your October 5, 2016 response makes no reference to any correction of these violations.
 
Dietary Supplement CGMP Violations
 
Even if your Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim with pure Hoodia Gordonii Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules and Black Seed w/ Olive Leaf/Garlic Capsules were not unapproved new drugs and misbranded 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)] in that these products, along with your Black Seed Honey Booster, Sweet Excitement Her Honey, Revive Honey Herbal Elixir, Flax Seed Oil, Black Seed Oil, and Black Cumin Seed Oil products and all of your other dietary supplement products, have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Our inspection of your facility revealed serious violations of 21 CFR Part 111. 
 
The inspection revealed the following violations of FDA’s dietary supplement CGMP regulations:
  1. You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, your firm has not established finished product specifications for any of the dietary supplement products that you manufacture and distribute. For example, our investigators observed that you had not established finished product specifications for the following products:
         Black Seed Honey Booster (16 oz.)
         Sweet Excitement Her Honey (12 oz., 16 oz.)
         Revive Honey Herbal Elixir (12 oz., 16 oz.)
 
During the inspection, you acknowledged that your firm had not established finished product specifications for any of the dietary supplement products that you manufacture and distribute. Once you have established product specifications, you must determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with the requirements in 21 CFR 111.75(c).
 
We have reviewed your response dated October 05, 2016; however, your response did not include finished product specifications for the aforementioned products. 
  1. You failed to establish specifications to provide sufficient assurance that the product you receive from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, your firm has not established these specifications for any of the products that you receive from a supplier for packaging or labeling as a dietary supplement. For example, our investigators observed that you had not established these specifications for the following products:
         Flax Seed Oil
         Black Seed Oil
 
Once you have established these specifications, you must determine and document whether the specifications are met, in accordance with the specific requirements of 21 CFR 111.75(e).
 
We have reviewed your response dated October 05, 2016, wherein you provided a product specification for Flax Seed Oil. Your product specification does not provide assurance that product you receive is adequately identified, because the specification does not indicate what test(s) or other methods are to be used in order to determine whether the stated specifications have been met. 
  1. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the current inspection you acknowledged that your firm does not have MMRs for the dietary supplements that you manufacture.
We have reviewed the example of a “master production record” submitted with your October 5, 2016 response to the FDA Form 483, which we understand to be an MMR. This MMR is for the product “Black Seed Honey Booster.” This MMR fails to include many of the requirements of 21 CFR 111.210. For example, this record lacks:
 
        A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
        A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)];
        Written instructions, including the following:
o   Specifications for each point, step, or stage in the manufacturing process where control is necessary 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 111.210(h)(1)];
o   Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary 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 111.210(h)(3)];
§ Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component [21 CFR 111.210(h)(3)(i)]; and
§ For manual operations, such specific actions must include:
·         One person weighing or measuring a component and another person verifying the weight or measure [21 CFR 111.210(h)(3)(ii)(A)]; and
·         One person adding the component and another person verifying the addition [21 CFR 111.210(h)(3)(ii)(B)].
o   Corrective action plans for use when a specification is not met. [21 CFR 111.210(h)(5)]
  1. 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, as required by 21 CFR 111.103 and 111.140(b)(1). Specifically, you acknowledged to our investigators that you have not established any written procedures for quality control operations. In addition, for the products that are manufactured, packaged, and labeled by your contract manufacturer (including Diabalance Herbal Blood Sugar, Black Cumin Seed Oil Softgel, and Quick Slim with pure Hoodia Gordonii) you do not perform quality control functions, such as reviewing and approving the documentation to determine whether the received product meets the specifications that you established under 111.70(f) [21 CFR 111.165(c)(2)] and, when a specification established in accordance with 111.70 is not met, rejecting the component, dietary supplement, package or label unless quality control personnel approve a treatment, an in-process adjustment, or reprocessing, as permitted in 111.77 [21 CFR 111.113(b)(2)].
Your October 5, 2016 response does not adequately address the above observation. We note that two procedures were submitted entitled: “Procedure/Process of step dealing with employee to ensure they are trained and qualified to complete operations” and “Procedure for processing physical plants and ground, cleaning procedure, established manufacture specifications, quality control specifications ‘Herbs etc.’” However, neither of these written procedures adequately established the aforementioned quality control procedures.
 
Further, your firm’s quality control operations must include approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h). During the inspection you acknowledged that your quality control operations do not include this step. In general, please be aware that you must implement quality control operations in your manufacturing, packaging, labeling and holding operations, as required by 21 CFR 111.65.
  1. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, you explained at the time of inspection that you only keep batch production records for dietary supplement products distributed outside of the United States, but do not keep batch production records for products distributed within the United States.
We have reviewed the Batch Production Record for Black Seed Oil, 16 oz, submitted with your October 5, 2016 response. The batch record fails to include many of the requirements of 21 CFR
111.260 that apply to this product. For example, it lacks:
  • The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross‐reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)];
  • The unique identifier that you assigned to each component (or, when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used [21 CFR 111.260(d)];
  • A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
  • The actual results obtained during any monitoring operation [21 CFR 111.260(g)];
  • The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
  • Documentation that the finished dietary supplement meets specifications established in accordance with 111.70(g) [21 CFR 111.260(i)];
  • Documentation, at the time of performance, of the manufacture of the batch, including:
    • The date on which each step of the master manufacturing record was performed (to be documented at the time of performance, not pre-printed) [21 CFR 111.260(j)(1)]; and
    • The initials of the persons performing each step, including [21 CFR 260(j)(2)]:
      • The initials of the person responsible for weighing or measuring each component used in the batch [21 CFR 111.260(j)(2)(i)];
      • The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
  • Documentation, at the time of performance, of packaging and labeling operations, including [21 CFR 111.260(k)]:
    • The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)];
    • An actual or representative label, or a cross‐reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2)]; and
    • The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)];
  • Documentation at the time of performance that quality control personnel [21 CFR 111.260(l)]:
    • Reviewed the batch production record, including [21 CFR 111.260(l)(1)]:
      • Review of any monitoring operation required under subpart E of this part [21 CFR 111.260(l)(1)(i)]; and
      • Review of the results of any tests and examinations, including tests and examinations conducted on components, in‐process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements [21 CFR 111.260(l)(1)(ii)];
    • Approved and released, or rejected, the batch for distribution, including any reprocessed batch [21 CFR 111.260(l)(3)]; and
    • Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(4)];
  • Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)]
  1. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). In accordance with 21 CFR 111.83(b), the reserve samples must:
        be held using the same container‐closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)];
        be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)];
        be retained for at least (1) year past the shelf life date (if shelf life dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(3)]; and
        consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specification [21 CFR 111.83(b)(4)].
 
Specifically, your firm did not ensure reserve samples are taken for any of your packaged and labeled dietary supplements you distribute. For example, our investigators observed that you had not collected and held reserve samples of each lot of the following products:
 
        Diabalance Herbal Blood Sugar Balance
        Black Cumin Seed Oil
        Quick Slim with pure Hoodia Gordonii
        Black Seed Oil
        Flax Seed Oil
        Black Seed Honey Booster
        Sweet Excitement Her Honey
 
During the inspection, you acknowledged that your firm had not collected and held reserve samples of each lot for any of the dietary supplement products that you distribute. Your October 5, 2016 response includes a “Packaging, Labeling and Holding Operations” form with a line that is designated “Reserve sample collected on.” Your response does not otherwise address the above requirements. The implementation of your corrective action will be verified at the next inspection. 
  1. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, your firm has no written procedures for holding and distributing operations. Please note that Subpart M of 21 CFR Part 111, which begins with 21 CFR 111.453, contains requirements relating to holding and distributing.
Your October 5, 2016 response does not address the above observation.
 
Misbranded Dietary Supplements
 
Even if your Diabalance Herbal Blood Sugar Balance Tablets, Quick Slim Hoodia Gordonii Diet Capsules, BHealthy Black Seed Bitter Melon 90 Veggie Capsules and Black Seed w/ Olive Leaf/Garlic Capsules were not unapproved new drugs and misbranded drugs, they would be misbranded dietary supplements. These products, along with your Black seed herb brand Sweet Excitement Her Honey, Sweet Sunnah brand Flax Seed Oil, Sweet Sunnah brand Black Seed Oil, 8 ounces, Sweet Sunnah brand Black Seed Oil, 32 ounces, Sweet Sunnah brand Black Seed Oil, softgels, and Sweet Sunnah brand Black Seed Honey Booster products, are misbranded as described below: 
  1. Your QuickSlim with pure Hoodia Gordonii, Black seed herb brand Sweet Excitement Her Honey, Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon, and Sweet Sunnah brand Black Seed Honey Booster products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the labels fail to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
  1. Your Sweet Sunnah brand Black Seed Oil, 32 ounces, Sweet Sunnah brand Black Seed Oil, softgels, products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain 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.
  1. Your QuickSlim with pure Hoodia Gordonii, Sweet Sunnah brand Flax Seed Oil, Sweet Sunnah brand Black Seed Oil, 8 ounces, Black Seed Oil, 32 ounces and Black Seed Oil, softgels, and Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the 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,
    1. Your QuickSlim with pure Hoodia Gordonii product label declares the dietary ingredient galangal, but this is not a standardized common name noted in the reference Herbs of Commerce.
    2. Your Sweet Sunnah brand Flax Seed Oil product label declares the dietary ingredient lignan (SDG), but this is not a common or usual name for a dietary ingredient.
    3. Your Sweet Sunnah brand Black Seed Oil, 8 ounce, Black Seed Oil, 32 ounces, and Black Seed Oil, softgels product labels declare ALA, LA or GLA, and OA, but these are not common or usual names for dietary ingredients.
    4. Your Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon label fails to list the capsule ingredients.
  1. Your QuickSlim with pure Hoodia Gordonii 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 labeled servings per container does not accurately reflect the actual number of servings, in accordance with 21 CFR 101.36(b)(1)(ii). The product label states that a serving is two capsules and the bottle is labeled to contain 60 capsules. This means that the total number of servings per container is 30, not 60 as declared on the label.
  1. Your Black seed herb brand Sweet Excitement Her Honey, Sweet Sunnah brand Black Seed Honey Booster, Sweet Sunnah brand Flax Seed Oil, Sweet Sunnah brand Black Seed Oil, 8 ounces and Black Seed Oil, 32 ounces, and Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon 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 presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically:
a.  Your Black seed herb brand Sweet Excitement Her Honey and Sweet Sunnah brand Black Seed Honey Booster products are labeled with a Nutrition Facts panel rather than the required Supplement Facts panel. Further, your label contains nutrients which may be declared as zero. Any (b)(2)-dietary ingredients not present, or in amounts that can be declared as zero in 21 CFR 101.9(c), must not be declared [21 CFR 101.36(b)(2)]
b.  Your Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon product has a Supplement Facts panel which is not in accordance with 21 CFR 101.36(d)(1)(i) in that it is not set off in a box by use of hairlines.
c.  Your Sweet Sunnah brand Flax Seed Oil product label lists polyunsaturated fat and monounsaturated fat in the wrong order. Polyunsaturated fat and monounsaturated fat, when declared, must be indented under total fat in accordance with 21 CFR 101.9(c)(2)(iii) and 101.9(c)(2)(iv).
d.  Your Sweet Sunnah brand Black Seed Oil, 8 ounces and Black Seed Oil, 32 ounces product labels declare “n/a” in the %DV column next to the (b)(3)-dietary ingredient. A symbol (e.g., an asterisk) must be placed in the %DV column that shall refer to the same symbol that is placed at the bottom of the nutrition label, below the last heavy bar and inside the box, and followed by a statement "Daily Value not established." 
  1. Your QuickSlim with pure Hoodia Gordonii, Black seed herb brand Sweet Excitement Her Honey, Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon, Sweet Sunnah brand Black Seed Honey Booster, and Sweet Sunnah brand Diabalance 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 labels fail 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).
  1. Your Black seed herb brand Sweet Excitement Her Honey and Sweet Sunnah brand Black Seed Oil, 8 ounces and Black Seed Oil, 32 ounces, Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon, and Sweet Sunnah brand Black Seed Honey Booster products are 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 declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2.
    1. The Black seed herb brand Sweet Excitement Her Honey product’s Nutrition Facts panel states that the serving size is 2 teaspoons. However, the “Dosage” instruction states “Take 2 Tablespoon (adult) daily….” The serving size must include the equivalent metric quantity in parentheses.
    2. The Sweet Sunnah brand Black Seed Oil, 8 ounces and Black Seed Oil, 32 ounces product’s Supplement Facts panel states that the serving size is “1 tsp.” However, the Directions states “take 1-2 teaspoonfuls.”
    3. The Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon Supplement Facts panel states that the serving size is “1 capsule.” However, the Suggested Use states “take 1-2 capsules.”
    4. Sweet Sunnah brand Black Seed Honey Booster serving size must include the equivalent metric quantity in parentheses.
  1. Your Sweet Sunnah brand Flax Seed Oil and Sweet Sunnah brand Black Seed Oil, 32 ounces products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. 
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically: 
    1. Your Sweet Sunnah brand Flax Seed Oil product label bears the claims “Rich in Omega-3 Fatty Acids” and “High Lignan.” However, this product does not meet the requirements that are set forth in 21 CFR 101.54(b) for use of these nutrient content claims. In accordance with 21 CFR 101.54(b)(1), you may use the term “high” or “rich in” on the label of foods provided that the food contains 20 percent or more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) for the nutrient, per reference amount customarily consumed (RACC). This regulation does not authorize claims about omega-3 fatty acids or lignin, as these nutrients do not have either an established RDI or DRV.
    2. Your Sweet Sunnah brand Black Seed Oil, 32 ounce product label includes the claim “maximum potency” which implies “high potency.” However, this product does not meet the requirements that are set forth in 21 CFR 101.54(f) for use of this nutrient content claim. In accordance with 21 CFR 101.54(f)(1), you may use the term “high potency” on the label of foods to describe individual vitamins or minerals that are present at 100 percent or more of the RDI per RACC. Similarly, in accordance with 21 CFR 101.54(f)(2), you may use the term “high potency” on the label of a multi-ingredient food product to describe the product if the product contains 100 percent or more of the RDI for at least two-thirds of the vitamins and minerals that are listed in 21 CFR 101.9(c)(8)(iv) and that are present in the product at 2 percent or more of the RDI. These regulations do not authorize the “maximum potency” claim on your Sweet Sunnah brand Black Seed Oil, 32 ounce product label, because this product does not contain any vitamins or minerals with an established RDI.
  1. Your Sweet Sunnah brand Diabalance and Sweet Sunnah brand Black Seed Honey Booster products are misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
  1. Your Sweet Sunnah brand Black Seed Oil, 8 ounces and 32 ounces and Black Seed Oil, softgels products 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 the labels fail to list the name of each ingredient of the supplement that is described in section 201(ff) and the quantity of each such ingredient. For example, your labeling indicates the product contains thymoquinone. You do not list this ingredient and you do not list the quantitative amount by weight per serving in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(3).
  1. Your Black seed herb brand Sweet Excitement Her Honey, Sweet Sunnah brand Black Seed Honey Booster, and Sweet Sunnah brand Flax Seed Oil products are misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act [21 U.S.C. § 343 (s)(2)(A)(ii)(I)] in that the labels fail to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36.
a.  Your Black seed herb brand Sweet Excitement Her Honey and Sweet Sunnah brand Black Seed Honey Booster product labels declare iron, but fail to include the quantitative amount per serving.
b.  Your Sweet Sunnah brand Flax Seed Oil product label declares lignan with an amount that is a range of values rather than the quantitative amount by weight per serving. 
  1. Your QuickSlim with pure Hoodia Gordonii, Black seed herb brand Sweet Excitement Her Honey, Sweet Sunnah brand Black Seed Honey Booster, Sweet Sunnah brand Flax Seed Oil, Sweet Sunnah brand Diabalance, Sweet Sunnah brand Black Seed Oil and Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Specifically, the address does not bear the zip code.
Although violations associated with your labels and website were discussed during the inspection, your October 5, 2016 response makes no reference to any correction of these violations.
 
This letter is not meant to be an all-inclusive list of the violations that may exist in connection with your products or their labeling. You are responsible for ensuring that your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations in this letter. Failure to promptly correct the violations may result in regulatory action without further notice, including seizure and/or injunction.
 
We also offer the following comments:
 
·         Your October 5, 2016 response includes a “Packaging, Labeling and Holding Operations” form. This form appears to be intended to demonstrate compliance with multiple requirements, but it does not identify what those requirements are. You should be aware that this form may not fully cover whichever requirements it is intended to address. We suggest that you review the requirements for each section of the regulation you are attempting to account for and ensure that this form and any other forms provide a structure for all of the relevant requirements to be met.
·         Your QuickSlim with pure Hoodia Gordonii, Sweet Sunnah brand Black Seed Oil, softgels, Sweet Sunnah brand Flax Seed Oil, and Sweet Sunnah brand Diabalance information panel includes ingredient information intermingled with information that is considered intervening material. All information appearing on the information panel of the product label should appear in one place without other intervening material in accordance with 21 CFR 101.2(e). Examples of intervening material:
o   Your QuickSlim with pure Hoodia Gordonii and Sweet Sunnah brand Black Seed Oil, softgels include the statement “Halal.”
o   Your Sweet Sunnah brand Flax Seed Oil includes the statement “Fresh cold-pressed, unrefined unfiltered virgin…”
o   Your Sweet Sunnah brand Black Seed Oil, 8 ounces includes the statement “Fresh cold-pressed in New York, unrefined virgin…” and your Sweet Sunnah brand Black Seed Oil, 32 ounces and Black Seed Oil, softgels includes the statement “freshly cold-pressed & unrefined virgin.”
o   Your Sweet Sunnah brand Diabalance includes Storage information within the Supplement Facts label.
 
·         Your Black seed herb brand Sweet Excitement Her Honey product label appears to misspell rose flavor as “rose flouver.”
 
·         The label shown on your Sweet Sunnah brand Diabalance product label bears Other Ingredients within the Supplement Facts panel. The ingredient list must be separate from the Supplement Facts panel.
 
·         The information panel for your Black seed herb brand Sweet Excitement Her Honey and Sweet Sunnah brand Black Seed Honey Booster is located to the left of the principal display panel. The information panel is defined as being the panel immediately contiguous and to the right of the principal display panel [21 CFR 101.2(a)]. Information required to be present on this panel includes: the statement of ingredients; name and address of the manufacturer, packer, or distributor; and, the Supplement Facts panel, unless they are present on the principal display panel.
 
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection 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 reinspection-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 reinspection-related costs.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter with the actions you plan to take in response to this letter. You should include in your response documentation such as revised SOPs, revised product labels and website labeling, or other useful information 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.
 
Your written response should be sent to: Lillian C. Aveta, Compliance Officer, New York District Office, Office of Human and Animal Food Operations East, Division 1, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail 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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