Inspections, Compliance, Enforcement, and Criminal Investigations

Alkebulan International Services, LLC 1/13/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Baltimore District Office
Central Region
6000 Metro Drive, Suite 1 01
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707 
 
WARNING LETTER
CMS# 458466
 
January 13, 2016
 
Via UPS
 
Mr. Asar Ra Gray, President
Alkebulan International Services, LLC
101 Eaton Street, Suite 100A
Hampton, VA 23663
 
Dear Mr. Gray:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your warehouse facility, located at 101 Eaton Street, Suite 100A, Hampton, VA 23663 from April 6th, 2015 to April 17th, 2015. The inspection revealed that you have serious violations of the FDA's regulations for Current Good Manufacturing Practices (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements under Title 21, Code of Federal Regulations (CFR), Part 111. These violations cause your Moringa Oleifera Capsules and Aloe Ferox dietary supplement products 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 CGMP requirements for dietary supplements. You may find the Act and its implementing regulations through links on FDA's home page at www.fda.gov.
 
In addition, FDA reviewed your product labeling collected during our inspection and your websites at the internet address http://alkebulanis.com and https://www.facebook.com/alkenaturals/ on October 14, 2015, and has determined that you take orders for your various Moringa and Aloe Ferox products that are being promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites and in your product labeling establish that the products are drugs 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.
 
Unapproved New Drugs
 
Examples of some of the claims that provide evidence that your Aloe Ferox Bitter Crystals and Moringa oleifera products, including Moringa Powder, Moringa Tea Bags, Moringa Seeds, and Moringa Capsules, are intended for uses as drugs include:
 
Aloe Ferox product
 
• "[African Aloe Ferox] Bitter Crystal...Such ailments are: Arthritis, rheumatism, gout, chronic constipation, intestinal parasites, tennis elbow, osteoporosis, goiter problems ... "
• "[A]nti-inflammatory, Anti Bacterial, Anti-Viral and Anti-Parasitic ... "
• "[I]ngested to help with...gout, rheumatism and arthritis ... "
 
Moringa Products
 
• "Clinical studies state that Moringa ... supports the immune system in fighting diseases as simple as the flu and as serious as CANCER."
• "Moringa & Cancer ... Cancer is the result of free radicals taking control of your tissues and bloodstream, damaging your cells and causing cancer growth .... [m]orina oleifera provides a rare combination of zeatin ... quercetin (a flavonoid known for its ability to ... relieve inflammation), beta-sitosterol (a nutrient superstar that blocks cholesterol formation or build-up and is an anti-inflammatory agent for the body), caffeoylquinic acid (another powerful anti-inflammatory compound) ... "
• "Moringa & Diabetes ... Moringa having all these nutrients and helps the diabetic patient to control their blood glucose level."
 
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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Adulterated Dietary Supplements
 
Even if your Aloe Ferox and Moringa Oleifera Capsule dietary supplement products did not have therapeutic claims which make them unapproved new drugs, these dietary supplements are adulterated within the meaning of section 402(g)(l) 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 the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements (21 CFR Part 111).
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements:
 
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 21 CFR 111.140(b)(l). Specifically, you stated that you were unaware of this quality control requirement and you did not have any written procedures for quality control operations for the dietary supplements you distribute.
 
Once you have established your quality control written procedures, you must implement quality control operations in your holding operations, as required by 21 CFR 111.65.
 
2)    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 holding and distributing operations of the dietary supplements you distribute.
 
3)    You failed to establish and follow written procedures relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, you did not have written procedures for handling product complaints for dietary supplements you distribute. Once you have established the necessary written procedures, you must make and keep all related records, as required by 21 CFR 111.570.
 
To the extent you contract with other manufacturers (b)(4) to manufacture, package, or label dietary supplements 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 your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (June 25, 2007)].
 
Further, your firm supplies product labels to your contract manufacturer, (b)(4) for the Moringa products. Therefore, you must establish label specifications, as required by 21 CFR 111.70(d) for the Moringa dietary supplements.
 
The violations described above are not meant to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and applicable FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, injunction and seizure under sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].
 
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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees [21 U.S.C. 379j-31(a)(2)(8)]. For a domestic facility, 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.
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Please send your written reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice by phone at 410-779-5463 or by email at david.rice@fda.hhs.gov.
 
Sincerely yours,
/S/
Evelyn Bonnin
District Director
Baltimore District Office

Page Last Updated: 01/19/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English