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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Aloe Man International Corp 3/21/14

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770

 

VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-14-07
March 21, 2014
 
 
Mark A. Dixon
President/Owner
Aloe Man International Corp.
18800 NW 2nd Ave. Ste. 200
Miami, FL 33169
 
Dear Mr. Dixon:
 
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 18800 NW 2nd Ave. Ste. 102 Miami FL from May 2 through May 13, 2013. We also reviewed labeling on your firm’s website at www.aloemanintl.com in January 2014. The inspection, and our review of your product labeling, revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.
 
You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
The inspection and our review of your product labeling revealed the following significant violations:
 
Unapproved New Drugs
 
Based on our review of your product labeling on your firm’s website at www.aloemanintl.com, we have determined that your GAP Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator products are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].  The therapeutic claims on your labeling establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.   
 
Examples of some of the claims on your website, www.aloemanintl.com, that provide evidence that your products are intended for use as drugs include:
 
GAP Pills
 
  • “Our GAP Pills is one of the best blood cleaners on the market. GAP Pills helps the body to cleanse the blood. We found that when you cleanse the blood, you can:
 
Lower the blood pressure
Lower the sugar level
Lower the cholesterol levels and get good circulation
 
Now there is scientific proof that we must cleanse our blood on a daily basis to avoid heart attack and strokes”
 
“Clots can form and cause heart attacks, strokes and poor circulation through the body. If you have numbness in the little finger or dull pain in your shoulder or arm or pain in your chest whenever you walk up a flight of stairs; you may be in stroke territory right now! Don't wait! Don't die! Don't wait until your mouth is twisted to one side and your leg is dragging behind you and you can't even dress yourself! Don't wait until it is too late. Available in 100 and 200 tab bottles.”
 
GAP Liquid
 
  • “The GAP Liquid is one of the best blood cleansers on the market and, as you know, when you clean your blood you can lower the Blood Pressure, lower the Cholesterol, lower the Sugar Level…”
 
THE BODY HEALER
 
  • “[C]an be put on the skin, and can be dropped in the eyes, ears, or nostrils to help the body to heal itself”
 
The BIG C
 
  • “[H]elps to get rid of fluid and swelling in the brain”
 
SUPER CLEANSER
 
  • “[E]limination of inflammation…supports the body’s own ability to fight pain, and clear congestion, obstruction, and accumulation.”
 
MAXIMUM DESIRE
 
  • “[F]ight off…impotence”
 
SOC
 
  • “[H]as an abundance of herbs that provide large amounts of organic potassium chloride…It is very important to have enough potassium chloride present in the blood to keep fibrin…in the blood....If not, the fibrin can leave the blood…and can cause such things as fibroids, fibrocystic breast, sarcoidosis, fibromyalgia, etc.”
 
High Thyroid Regulator
 
  • “[S]upports the body in its ability to regulate an overactive thyroid”
 
Low Thyroid Regulator
 
  • “[S]upports the body in its ability to regulate an underactive thyroid”
 
These products are not generally recognized as safe and effective for the above referenced uses and, therefore, each of these products is a “new drug” 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 the 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 GAP Pills, GAP Liquid, SOC, Maximum Desire, and High Thyroid Regulator 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 uses. 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)].
 
Dietary Supplement CGMP Violations
 
Your dietary supplement products are 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 the Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 [21 CFR Part 111].  In addition, even if your GAP Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator products were not unapproved drugs, they would also be adulterated dietary supplements under section 402(g)(1) of the Act.
 
Further, with respect to your Body Healer product, we note that on your firm’s website, you state that your Body Healer product “can also work on the outside of the body” and “can be put on the skin, and can be dropped in the eyes, ears, or nostrils.” However, dietary supplements must be intended for ingestion. See section 201(ff)(2) of the Act [21 U.S.C. §§ 321(ff)(2)].  In other words, to be a dietary supplement, a product must be intended to be taken into the digestive tract by swallowing.  To the extent that your Body Healer product is intended for a delivery method other than ingestion, as evidenced by the statement on your website, the product is not a dietary supplement and may not be marketed as such.
 
Specifically, during the inspection, investigators observed the following significant violations:   
 
1.    Your firm failed to 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).  Specifically, your firm does not perform any testing to verify the identity of the raw materials used in the manufacturing of your dietary supplements.  For example, you did not conduct identity testing for the following dietary ingredients:
 
a.   Bayberry, Quassia bark, and Clove used in the manufacturing of Body Healer (lots 10240, 10241, 10242) which were distributed via, but not limited to, invoice numbers 3041 dated 4/8/13, 3111 dated 4/24/13, and 3130 dated 4/29/13.
 
b.   Marigold, Lilly of Valley, and Echinacea used in the manufacturing of Immuno Force (lots 70733, 70734, 70735) which was distributed via, but not limited to, invoice numbers 256 dated 4/18/13 and 3152 dated 5/1/13.
 
c.   Ginger, Hydrangea, and Irish Moss used in the manufacturing of Formula C (lots 10181, 10182, 10183) which was distributed via, but not limited to, invoice numbers 3076 dated 4/12/13 and 3135 dated 4/29/13. 
 
2.    Your firm failed to qualify suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, your firm does not qualify your suppliers to establish the reliability of their certificates of analysis for components other than dietary ingredients used in the manufacture of your dietary supplements. 
 
3.    Your firm failed to establish required specifications for 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, as required by 21 CFR 111.70(a).
 
  • You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
  • You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met, as required by 21 CFR 111.70(c).
  • You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with dietary supplements, as required by 21 CFR 111.70(d).
  • You failed to establish product specifications 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, as required by 21 CFR 111.70(e).
  • You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, as required by 21 CFR 111.70(g).
 
Once you have established the above specifications, you must determine whether the specifications have been met as required by 21 CFR 111.73 and make and keep records in accordance with 111.95(b). 
 
4.    You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation and batch size of a dietary supplement that you manufactured as required by 21 CFR 111.205(a), in accordance with the requirements in 21 CFR 111.205(b). Specifically, you did not follow your master manufacturing record for Body Healer (lots 10240, 10241, 10242), Immuno Force (lots 70733, 70734, 70735), and Formula C (lots 10181, 10182, 10183).
 
5.    You failed to prepare a complete batch record every time you manufactured a batch of dietary supplements as required by 21 CFR 111.255. Specifically, the batch record for your Body Healer (lots 10240, 10241, 10242), Aloe Man Big “C” (lots 70733, 70734, 70735) and Dr. Johnson’s Formula-C (lots 10181, 10182, 10183) failed to contain the following information for a batch record as required in 21 CFR 111.260:
 
  • The batch, lot or control number for each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement [21 CFR 111.260(a)(2)].
  • The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
  • 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 the records [21 CFR 111.260(c)].
  • The identity and weight or measure of each component used [21 CFR 111.260(e)].
  • 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 which were obtained during the monitoring of operations [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(e) and (g) [21 CFR 111.260(i)].
  • Documentation of the manufacture of the batch at the time of performance [21 CFR 111.260(j)], including:  

 

o   The date on which each step of the MMR was performed as required by 21 CFR 111.260(j)(1).
 
o   The initials of the persons performing each step as required by 21 CFR 111.260(j)(2) including;
 

The initials of the person responsible for weighing or measuring each component used in the batch as required by 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 as required by 21 CFR 111.260(j)(2)(ii).

The initials of the person responsible for adding the component to the batch as required by 21 CFR 111.260(j)(2)(iii).

The initials of the person responsible for verifying the addition of components to the batch as required by 21 CFR 111.260(j)(2)(iv).

 

  • Documentation, at the time of performance, of packaging and labeling operations [21 CFR 111.260(k)], including:
 
o   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 as required by 21 CFR 111.260(k)(1).
o   The results of any tests or examinations conducted of packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results as required by 21 CFR 111.260(k)(3).
 
  • Documentation at the time of performance that quality control personnel reviewed any monitoring operations [21 CFR 111.260(l)(1)(i)].
  • Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)].
 
6.      Your firm does not have written procedures for quality control operations. Therefore, you have 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. 
 
7.      You failed to quarantine components prior to their use in the manufacture of the finished dietary supplements as required by 21 CFR 111.155(c). 
 
8.      You did not 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). Specifically, your firm does not collect reserve samples of any of the dietary supplement products that you distribute as capsules and tablets. Although you collect reserve samples for liquid dietary supplements that you manufacture, you only collect four-ounce samples. Four ounces is not a sufficient quantity, because it is not at least twice the quantity necessary to conduct tests or examinations to determine whether or not the dietary supplement meets product specifications, as required under 21 CFR 111.83(b)(4).
 
9.      A qualified person did not investigate product complaints that involved possible failures of dietary supplements to meet specifications, or other CGMP requirements as required by 21 CFR 111.560(a)(2). For example, you did not investigate a complaint of illness you received on 11/7/12.  Furthermore, you failed to keep product complaint records in accordance with 21 CFR 111.570(b)(2)(ii). Your complaint record did not include a product description, lot number, name and contact information of the complainant, product use, and investigation findings. More generally, your firm has not established written procedures for recording product complaints, as required by 21 CFR 111.553.
 
10.    You did not establish and follow written procedures for fulfilling requirements for returned dietary supplements, as required by 21 CFR 111.503. 
 
11.  You failed to comply with 21 CFR 111.27(a), which requires use of equipment and utensils of appropriate design, construction, and workmanship to enable them to be suitable for their intended use. Specifically, your (b)(4), used to measure ingredients for the manufacturing of dietary supplements, is not intended for commercial use.
 
Misbranded Dietary Supplements
 
Your Immuno Force and Dr. Johnson’s Formula-C dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101. Further, if your Body Healer product did not have disease claims, which make this product an unapproved drug, it would also be misbranded for the same reason if it is intended for ingestion and qualifies as a dietary supplement under section 201(ff) of the Act.  
 
1.    Your Dr. Johnson’s Formula-C product is misbranded under Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] in that the product label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product.
 
2.    Your Dr. Johnson’s Formula-C, Dr. Johnson’s Body Healer, and Aloe Man’s Immuno Force 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 ingredients by their common or usual name.
 
  • Your Dr. Johnson’s Formula-C lists “Arismatis” and “Amomi” as dietary ingredients; however, they are not listed by their common or usual name. Your Dr Johnson’s Formula-C product label also declares “Other Herbs Not Mentioned” and therefore you do not include the common or usual name of all dietary ingredients when they are present in a dietary supplement in accordance with 21 CFR 101.36(b)(3) and 21 CFR 101.4(h).
  • Your Aloe Man’s Immuno Force product label lists “Our Lady’s Tears”, but this name is not the common or usual name for this botanical dietary ingredient in accordance with 21 CFR 101.4(h).
  • Your Dr. Johnson’s Formula-C, Dr. Johnson’s Body Healer, and Aloe Man’s Immuno Force product labels declare a “stabilizer” under other ingredients; however the labels fail to declare the common or usual name of the specific stabilizer ingredient in accordance with 21 CFR 101.4.
 
3.    Your Dr. Johnson’s Formula-C, Dr. Johnson’s Body Healer, and The Aloe Man’s Immuno Force products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the labels fail to declare the quantitative amount by weight per serving of each dietary ingredient or the proprietary blend of dietary ingredients as required by 21 CFR 101.36(b)(3) and 21 CFR 101.36(c). 
 
4.    Your Dr. Johnson’s Formula-C and Aloe Man’s Immuno Force 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 parts of the plants from which some of these botanical dietary ingredients were derived in accordance with 21 CFR 101.4(h)(1). For example, Dr. Johnson’s Formula-C fails to list the part of the plant for all of the botanical ingredients listed in the information panel and Aloe Man’s Immuno Force fails to list the part of the plant from which “Swallow” and “Our Lady’s Tears” were derived.
 
The above is not intended to be an all-inclusive list of violations in connection with your products. You should take prompt action to correct all violations. It is your responsibility to ensure that your firm complies with all requirements of the Act and and FDA’s regulations. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.  
 
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.
 
You should respond 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 noted above. You should include in your response documentation and any 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.
 
Please send your written reply to the Food and Drug Administration, Attention: Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
                                                                       
Sincerely,
/S/
Elizabeth W. Ormond
Acting Director, Florida District