April 3, 2019

CMS # 558414

WARNING LETTER

UPS Overnight

Mr. John W. Sigrist, President/Owner

Texas Aloe Corporation, Inc.

1947 Mile 6 North

Mercedes, Texas 78570-4680

Dear Mr. Sigrist

From April 25, 2018, through May 3, 2018, and August 28 through August 30, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your Aloe Vera Juice and Aloe Vera Leaves manufacturing facility located at 1947 Mile 6 North, Mercedes, Texas 78570. During the inspection, we also collected labeling for your products. Based on a subsequent review of your product labels collected during the inspection and a subsequent review of your website at the internet address www.aloeking.com, we have identified 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 website at www.fda.gov.

We acknowledge receipt of your response dated September 7, 2018, concerning our investigator’s observations issued to you at the close of the inspection.

Unapproved New/ Misbranded Drugs

FDA reviewed your website at the Internet address www.aloeking.com in February 2019 and has determined that you take orders there for your products Aloe Vera Juice and Aloe Vera Leaves. The claims on your website establish that the Aloe Vera Juice product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.   

Your website contains evidence of intended use in the form of a personal testimonial recommending or describing the use of Aloe King Aloe Vera Juice for the cure, mitigation, treatment, or prevention of disease. The testimonial states, “Your juice has stopped my acid reflux problem . . . Before I started taking Aloe King Aloe Vera Juice I was taking Zantac daily, no more Zantac, it has been replaced by Aloe King!”

Your Aloe King Aloe Vera Juice product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product 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 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 product Aloe King Aloe Vera Juice is 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 product safely for its intended purposes. Accordingly, your Aloe King Aloe Vera Juice product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Unapproved New Drug Promoted for Topical Use

Your website www.aloeking.com also contains the claim for your Aloe Vera Leaves product, “used . . . to treat wounds, skin infections, burns, and numerous dermatologic conditions.”

The above claim for the product demonstrates that it is a drug, as defined by the Act, 21 U.S.C. § 321(g), because it is intended to cure, mitigate, treat, or prevent disease or to affect the structure or function of the body of man or other animals. Moreover, this product is a “new drug,” as defined by 201(p) of the Act [21 U.S.C. § 321(p)], because there is no evidence that it is generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. There are no approved applications in effect for this product.

Misbranded Food

 Even if your Aloe Vera Juice product were not an unapproved and misbranded drug, violations of the food labeling rules found in 21 CFR part 101 would cause it to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Our review of your product labeling collected during our inspection and subsequent review of your website revealed the following violations:

1.    We have reviewed the labeling for your Aloe Vera Juice product and determined that it is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labeling is false and misleading, as follows:

a.  The product label characterizes the product as a fruit or vegetable juice, but it does not meet the regulatory definition of juice. The label bears the statements, “100% Pure Juice” and “100% Aloe Vera Juice.” In addition, the product page on your website www.aloeking.com, which is listed on your product label and where the product can be purchased, also bears the statements, “100% Pure Aloe Vera Juice,” “Aloe Juice,” and “Pure Aloe Vera Juice.”

These statements are false and misleading because they represent the product as a fruit or vegetable juice. Juice is defined as “the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” [21 CFR 120.1(a)] Although we do not dispute that Aloe Vera is a member of the vegetable kingdom in the broad sense of classifying an article as “animal,” “vegetable,” or “mineral,” FDA considers the term “vegetable” in the context of the juice definition to refer more narrowly to edible plant parts that consumers are accustomed to eating as vegetables in their diet.[1] Aloe Vera is not a vegetable in this sense. While consumers can purchase pieces of Aloe Vera, consumers do not eat Aloe Vera as a “vegetable”. There are other plant juices used for human food that similarly are not “vegetable juice” or “fruit juice” for purposes of the juice definition (e.g. maple syrup and sorghum syrup).

Further, we note that during the inspection management stated that the product does not contain 100% aloe, and that in fact the product contains approximately (b)(4)% aloe and (b)(4)% water. However, as stated above, the product label and website bear statements that the product contains 100% aloe, and water is not declared on the finished product label.

b.  FDA considers use of the term “natural” on a food label to be truthful and non-misleading when nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be in the food (58 FR 2302, 2407, January 6, 1993). Your website states that your Aloe Vera Juice is “natural stabilized.” This is an example of a use of the term “natural” for this product that is false or misleading. Your product includes synthetic ingredients because it is stabilized with (b)(4), which are synthetic ingredients added as preservatives.

We also note that your product contains (b)(4), which may be natural or synthetic, depending on how it is produced. We are unsure of how it is produced for your product, but if it is synthetic, it is another reason why the use of the term “natural” on your website is false or misleading.

c.  The characterization of the Aloe Vera Juice as “fresh” on the firm’s website is false or misleading because it does not meet the requirements of 21 CFR 101.95. The term “fresh” when used on the label or in labeling of a food in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation, except as provided in paragraph 21 CFR 101.95(c). Your website states, “Providing ‘Farm Fresh’ High Quality Pure Aloe Vera juice, leaves, plants and gel for over 40 years” and “Our vision was to bring farm fresh Aloe Vera Gel, Aloe Vera Juice, and Aloe Vera Leaf to the mainstream consumer market in its most natural form.”  However, your Aloe Vera Juice product is made with several preservatives and has been cooked. Therefore, it cannot be characterized as “fresh” In accordance with 21 CFR 101.95(c).

d.  Your website www.aloeking.com bears a statement on your homepage that describes your manufacturing facility as FDA approved. This statement is misleading because FDA does not approve manufacturing facilities.

2.    Your “Aloe Vera Juice” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. The product contains water and (b)(4) but the product label’s ingredient statement fails to list these ingredients. 

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. 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 your firm complies with all requirements of federal law and FDA 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, including, without limitation, seizure and/or injunction.

Additional Comment

We note that during the August 2018 inspection, your firm stated that the Aloe Vera used in your Aloe Vera Juice product varied in pH from approximately (b)(4) to (b)(4) based on growing conditions. Your firm also stated that (b)(4) is added to (b)(4) your Aloe Vera Juice product. (b)(3)(A)Commercial processors who manufacture, process, o, as well as the process filing requirements of 21 CFR 108.25(c)(2). An acidified food is a low-acid food (pH greater than 4.6) to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity greater than 0.85. 21 CFR 114.3(b), (d). Your response dated September 7, 2018 included an attached copy of FDA form 2541, food canning establishment registration, which lists your “Aloe Vera Vegetable Juice” as an acidified food. We note that our Low-Acid Canned Food (LACF) office has not received an electronic or hard copy of your form 2541 or a process for your Aloe Vera Juice. The paper form should be mailed to the address listed on the FDA 2541 or an electronic form can be submitted online. Information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format’’ available at: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.

You may also contact the LACF Registration Coordinator by email at LACF@FDA.HHS.GOV or by phone at 240-402-2411 if you have any questions.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please submit your response to Paul E. Frazier, Compliance Officer, at the address of 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions, please contact Mr. Frazier at (214) 253-5340. 

Sincerely,

/S/                                                           

Edmundo Garcia Jr.

District Director

Program Division Director

Office of Human and Animal Food, WD3

Cc:      

Lori Woznicki, Food and Drug Inspections Branch

Manager Division of Regulatory Services

Texas Department of State Health Services

1100 E. 49^th Street – Mail code 1987

Austin, Texas 78756

[1] https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM502679.pdf