Black Seed Herb, Inc. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

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

Potential Health Risks

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).

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,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.Your Sweet Sunnah brand Flax Seed Oil product label declares the dietary ingredient lignan (SDG), but this is not a common

Your Sweet Sunnah brand Bhealthy Blood Sugar Black Seed with Bitter Melon label fails to list the capsule ingredients.

Regulatory Context

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:

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:

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.