Inspections, Compliance, Enforcement, and Criminal Investigations

Aloe Farms, Inc 7/15/16

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

July 15, 2016
 
Ref: 2016-DAL-WL-29
WARNING LETTER
UPS OVERNIGHT MAIL
 
Mrs. Catherine J. Martin
General Manager and Treasurer
Aloe Farms, Inc.
3102 Wilson Road
Harlingen, Texas 78552
 
Dear Mrs. Martin:
 
The U.S. Food and Drug Administration (FDA or we) inspected your facility, located at 41076 Schafer Road, Los Fresnos, Texas, from December 7 through 11, 2015. Based on our inspection and subsequent review of your product labeling collected during the inspection, as well as your firm's websites, we found 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. Our investigator's observations were noted on the FDA-483, lnspectional Observations, which was issued to you on December 11, 2015.
 
Acidified Foods and Food CGMP Violations
 
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, 21 CFR Part 114, Acidified Foods, and 21 CFR Part 110 current Good Manufacturing Practices. The Emergency Permit Control regulation was issued , in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov.
 
Based on your failure to comply with the requirements of CGMP in 21 CFR 110, 21 CFR 108, and 21 CFR 114, we have determined that your food products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed , or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
 
The inspection revealed the following significant violations:
 
1.    As a commercial processor in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, your firm failed to file scheduled processes with FDA for your Aloe Farms Aloe Vera Juice and (b)(4) Cranberry Flavored Aloe Vera Liquid Whole Leaf Full Strength Herbal Supplement which have been determined to be acidified food products.
 
In addition, a commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packaging of acidified foods in any state, as defined in section 201(a)(1) of the Act, to register and file a Form FDA 2541 (Food Canning Establishment Registration) with the FDA, as required by 21 CFR 1 08.25(c)(1 ). However, our inspection indicates that your firm processes acidified food products without being registered as a processor of acidified foods.
 
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More 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 2541 g (Food Process Filing Forms) to FDA in Electronic or Paper Format" available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm.
 
2.    Your firm failed to have your scheduled processes established by a qualified person who has expert knowledge acquired through appropriate training and experience in manufacturing of acidified foods, as required by 21 CFR 114.83.
 
Specifically, the scheduled process for your Aloe Farms Aloe Vera Juice and (b)(4) Cranberry Flavored Aloe Vera Liquid Whole Leaf Full Strength Herbal Supplement were not established or evaluated by a process authority.
 
You should evaluate any other products you manufacture to determine if they are acidified foods required to comply with 21 CFR Part 108 (Emergency Permit Control), and 21 CFR Part 114 (Acidified Foods).
 
3.    You failed to maintain food contact surfaces to protect food from being contaminated by any source, as required by 21 CFR 110.40(a).
 
Specifically, the investigator observed the conveyor belt used to convey washed aloe vera leaves from the cleaning room to the processing room to contain numerous small cracks that do not allow for the proper cleaning and sanitization.
 
4.    You failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition that protects against contamination of food and food contact surfaces, as required by 21 CFR 110.35(a).
 
Specifically, there is no utensil-washing sink installed in the production room to allow the washing, rinsing, and sanitizing of food utensils. According to your firm's Quality Assurance Manager, the utensils are washed inside the employee hand wash sink.
 
5.    You failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7).
 
Specifically, the investigator observed an approximately 1/4" gap at the bottom of the entrance door located at the southeast corner of the production room, the warehouse door located at the southwest corner of the production room, the warehouse door located at the southeast corner of the shipping/receiving area, and in the wall area surrounding the employee hand wash sink drain pipe located at the northeast corner of the production room. These gaps could allow pests to enter the production room.
 
6.    You failed to construct or maintain the plant in such a manner as to prevent drip and condensate from contaminating food and food contact surfaces, as required by 21 CFR 110.20(b)(4).
 
Specifically, the investigator observed small gaps at the roof-wall juncture of the north production room wall. Equipment used to extract aloe vera juice from pulp is stored below this area. These gaps could allow rain to enter the production room.
 
7.    You failed to adequately install and maintain plumbing in order to properly convey sewage and liquid disposable waste from the plant, as required by 21 CFR 110.37(b)(2).
 
Specifically, the investigator observed the PVC drain pipe of the employee hand wash sink located at the northeast wall of the production room to be leaking water and not capped to the sewer pipe at the exterior of the building.
 
Dietary Supplement CGMP Violations
 
Your (b)(4) Cranberry Flavored Aloe Vera Liquid Whole Leaf Full Strength Herbal Supplement is a dietary supplement within the meaning of Section 201 (ff) of the Act [21 U.S.C. 321 (ff)]. Based on our observations during the inspection, this product and any other dietary supplements you manufacture are adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111.
 
A review of the labels for your Aloe Farms Aloe Capsules and (b)(4) Whole Leaf Aloe Vera Capsules shows that they include directions for use "[a]s a convenient means of adding this substance to the diet." Based on your use of this statement, it appears you may intend to market these products as dietary supplements. As discussed further below, these products are not properly labeled as dietary supplements. If you intend to market these products as dietary supplements, you must comply with the applicable statutory and regulatory requirements, including 21 CFR Part 111 and the nutrition labeling requirements under 21 CFR 101.36.
 
The inspection revealed the following significant violations:
 
8.    You failed to establish component specifications that are necessary to ensure that the specifications for purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2) and to establish limits on those types of contamination that may adulterate or 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(b)(3). During the inspection, you told our investigator that you had not established component specifications for the dietary supplements that you manufacture.
 
9.    You failed to establish finished product specifications for identity, purity, strength, and composition for the finished batch of each dietary supplement you manufacture, as required by 21 CFR 111.70(e).
 
Specifically, you have not established finished product specifications for any of the dietary supplement products you manufacture. Once you have established the required specifications, you must verify your finished dietary supplements meet those product specifications for identity, purity, strength, and composition, using the procedure set forth in 21 CFR 111.75(c).
 
10.    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). During the inspection, you told our investigator that you have not developed any type of written MMR for each batch size of dietary supplement that your firm manufactures.
 
11.    You failed to prepare a batch production record (BPR) every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). Your BPRs must include information that meets the requirements of 21 CFR 111.260. You told our investigator that you do not prepare a batch production record every time that you manufacture a batch of dietary supplement.
 
12.    You failed to qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). You confirmed, during the inspection, that you relied on certificates of analysis (COA) from the suppliers of components used in your dietary supplement products to confirm the identity of these components, but failed to qualify the suppliers of components used in your dietary supplement products by establishing the reliability of the supplier's COA through confirmation of the results of their tests or examinations.
 
Specifically, you received from your supplier certificates of analysis for potassium sorbate, ascorbic acid, and citric acid used to manufacture the (b)(4) Cranberry Flavored Aloe Vera Liquid Whole Leaf Full Strength Herbal Supplement and relied on their results without qualifying the suppliers through confirmation of the results of their tests or examinations.
 
13.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. When our investigator asked if you have developed written procedures for the responsibilities of the quality control operations, you stated that you have not. Further, during the inspection, you could not provide written procedures for quality control operations including the information required under 21 CFR 111.105 and 111.123.
 
14.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. During the investigation you confirmed to our investigator that you do not have written procedures for holding and distributing operations. Please note that your holding and distributing operations must operate in compliance with Subpart M of 21 CFR Part 111.
 
Unapproved New Drugs and Misbranded Drugs
 
We reviewed your websites at the internet addresses http://www.thealoeverastore.us/ and http://www.aloeverafarms.com/skin-solutions.html in January and April 2016, and have determined that you take orders there for several of your topical products, including your Aloe Vera Hand & Body Therapy, Multi-Defense Anti-Aging Moisturizer, Daily Aloe Vera Antioxidant Gel, Hydra Aloe Mist, Moisture Restore Night Treatment, Aloe Face Cleaner, and Aloe Vera Gel.
 
The claims on your website establish that the Aloe Vera Hand & Body Therapy, MultiDefense Anti-Aging Moisturizer, Daily Aloe Vera Antioxidant Gel, Hydra Aloe Mist, Moisture Restore Night Treatment, Aloe Vera Gel, and Aloe Face Cleaner products are drugs under sections 201 (g)(1)(B) and/or 201 (g)(1)(C) of the Act [21 U.S.C. § 321 (g)(1)(B) and/or 201 (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the website claims that provide evidence that these products are intended for use as drugs include:
 
•  Aloe Vera Gel
"Perfect for those with ulcers ... "
•  "Aloe vera Gel... cures everything. If you have a blister: Aloe Vera."
•  "HOW IT WORKS ... :
o  Speeds Healing, tensile strength and repair of damaged skin, wounds, burns, and other injuries
o  Fight infections with it's antibacterial properties
o  Anti-inflammatory agents reduces inflammation and redness
o  Relieves itching and swelling of irritated skin ... "
 
Multi-Defense Anti-Aging Moisturizer
•  From Product Description: "[M]otivate cell regeneration ... "
 
Daily Aloe Vera Antioxidant Gel
•  From Product Description: "[P]rotect skin's collagen. With the ability to balance skin and reduce wrinkles ... "
 
Hydra Aloe Mist
•  From Product Description: "(R]epair skin while balancing pH ... "
 
Your Aloe Vera Gel, Aloe Vera Hand & Body Therapy, Multi-Defense Anti-Aging Moisturizer, Daily Aloe Vera Antioxidant Gel, Hydra Aloe Mist, Moisture Restore Night Treatment, and Aloe Face Cleaner products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 C.F.R. § 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 Aloe Vera Gel product is intended for treatment of one or more diseases that are not amenable to self-diagnosis and treatment. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, this 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 these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Additionally, based on our review of the product label, collected during the inspection of your facility, your Aloe Farms Aloe Vera gelee product is labeled for use in healing "minor cuts," "scrapes," "burns," "rashes," "sunburns," "scars," and "bedsores." Its labeled ingredients are Aloe Vera Fillet, Carbomer (thickener), and Vitamin C (preservative).
 
Based on the labeling described above, Aloe Farms Aloe Vera gelee is a drug, as defined in section 201 (g) of the Act, [21 U.S.C. § 321 (g)), because it is intended for use in the cure, mitigation, treatment, or prevention of disease, and/or because it is intended to affect the structure or any function of the body of man.
 
Drug products intended for external analgesic indications are being evaluated in the OTC Drug Review. FDA has published a Tentative Final Monograph (TFM) for OTC external analgesics that proposes the conditions under which OTC external analgesic products are generally recognized as safe and effective and not misbranded (48 FR 5852, February 8, 1983). While the TFM includes active ingredients for the pain and/or itching associated with minor cuts, scrapes, burns, and sunburns, it does not include any ingredients for use in the "healing" of these indications, nor does it include any indications related to scars and/or bedsores. Such indications are not included in any rulemaking being considered under the OTC Drug Review. Further, we are not aware of a product with these ingredients for topical application to treat any of the conditions found in the labeling of Aloe Farms Aloe Vera gelee having been available in the U.S. market as an OTC drug at the inception of the OTC Drug Review or otherwise being eligible for inclusion. We are also not aware of any evidence establishing that the product, as formulated and labeled, is generally recognized as safe and effective as an OTC external analgesic drug product. Thus, the current marketing of Aloe Farms Aloe Vera gelee violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331 (d) and 355(a)) because it is a "new drug" and it is not the subject of an approved New Drug Application.
 
As a distributor of aloe vera containing products, you also should be aware of the tentative order that published in the Federal Register on June 19, 2008 titled "Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients." This tentative order proposes that any OTC drug products that contain aloe vera as an active ingredient and are labeled with claims or directions for use as an external analgesic or topical antimicrobial would not be generally recognized as safe and effective, and therefore would be considered new drugs. Should this rule finalize as written, any external analgesic and/or antimicrobial OTC drug product containing aloe vera as an active ingredient must first be the subject of an approved NDA prior to its introduction into interstate commerce (73 Fed. Reg. 34895 at 34896, 34897; June 19, 2008).
 
Further, 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 C.F.R. § 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 Aloe Vera gelee product is offered for conditions that are not amenable to self-diagnosis and treatment. In particular, the treatment of bedsores is not an indication included for consideration in the OTC Drug Review, and it is not amenable to self-diagnosis and treatment. Therefore, it is impossible to write adequate directions for a layperson to use this product safely for its intended purposes. Accordingly, this 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)].
 
Lastly, please be aware that all drug products are subject to drug establishment registration and drug listing requirements described in section 510 of the Act (21 U.S.C. § 360) and in 21 CFR 207, drug labeling described in section 502 of the Act (21 U.S.C. § 352) and in 21 CFR 201, and current good manufacturing practices (CGMPs) for drugs described in section 501 of the Act (21 U.S.C. § 351) and in 21 CFR 210 and 211, among other requirements.
 
Misbranded Dietary Supplements
 
Your (b)(4) Cranberry Flavored Aloe Vera Liquid Whole Leaf Full Strength Herbal Supplement is a dietary supplement within the meaning of Section 201 (ff) of the Act [21 U.S.C. 321 (ff)]. Based on our observations during the inspection, this product is misbranded for the reasons below.
 
A review of the labels for your Aloe Farms Aloe Capsules and (b)(4) Whole Leaf Aloe Vera Capsules shows that they include directions for use "[a]s a convenient means of adding this substance to the diet. "Based on your use of this statement, it appears you may intend to market these products as dietary supplements. As mentioned above, and as described further below, these products are not properly labeled as dietary supplements. If you intend to market these products as dietary supplements, they must be labeled in accordance with 21 CFR 101.1, 21 CFR 101.3, and the nutrition labeling requirements in 21 CFR 101.36. Specific deviations from these regulations are noted below.
 
15.    Aloe Farms Aloe Capsules and (b)(4) Original Whole Leaf Aloe Vera Capsules deviate from Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they do not declare all ingredients listed on the product labels in accordance with 21 CFR 101.4(g). For example, the products are encapsulated but the capsule ingredients are not listed.
 
16.    Your Aloe Farms Aloe Capsules deviate from Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the label fails to identify the product by using the term "dietary supplement" as required by 21 CFR 101.3(g).
 
17.    Your (b)(4) brand Cranberry Flavored Aloe Vera Liquid Herbal Supplement product is 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 you have elected to present on the labeling of your product does not comply with 21 CFR 101.36. Specifically,
 
•  Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 101.9(c), shall not be declared. [21 CFR 101.36(b)(2)(i)].
 
•  Calories must be expressed to the nearest 5-calories increment. [21 CFR 101.9(c)(1)].
 
•  For dietary ingredients for which DRV's have been established, "<1 %" shall be used to declare the % Daily Value when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the % Daily Value when rounded to the nearest percent is zero. [21 CFR 101.36(b)(2)(iii)(C)].
 
•  The label does not include the quantitative amount by weight per serving in metric units of the (b)(2)-dietary ingredient, vitamin C. [(21 CFR 101.36(b)(2)(ii)(B)].
 
•  The Supplement Facts panel shows a serving size of 2 fl. oz. and 16 servings per container which would result in a package which contains only 32 fl. oz., not the 128 fl. oz. noted as the net quantity of contents.
 
Misbranded Conventional Foods
 
18.    Your Aloe Farms brand Aloe Vera Juice product is misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product label is false or misleading. For example:
 
•  The label uses the term "Natural" on the front of the package to describe the product. This use of the term "natural" is false or misleading. 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 expect to be in the food (58 FR 2302, 2407, January 6, 1993). This product is manufactured with potassium sorbate which is a synthetic ingredient. We also note that your product contains ascorbic acid, 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 product label is false or misleading.
 
•  The claim "No Carbohydrates," on the firm's website, www.aloeverafarms.com, is false or misleading because one serving of the Aloe Vera Juice contains 4 g of Total Carbohydrates, based on the label declaration.
 
•  The characterization of the Aloe Vera Juice as "fresh" on the firm's website, www.thealoeverastore.us, is false 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). The webpage states "Our freshly make Aloe Farms Aloe Vera Juice. The miracle plant ... is bottled fresh and pure .... " The product is made with several preservatives and has been cooked. Therefore, it cannot be characterized as "fresh."
 
•  The Aloe Vera Juice 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 "Aloe Vera Juice," "Contains 99% Juice," "lngredients: ... Aloe Vera Juice," and "May mix it with other vegetable or fruit juices ... " These statements are false and misleading because they represent this product as a fruit or vegetable juice. Juice is defined as "the aqueous liquid expressed or extracted from one or more fruits of 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. 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.1
 
19.    Your Aloe Vera Juice product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does 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, the claim "Polysaccharide Rich," on the firm's website, www.aloeverafarms.com, and on the Aloe Vera Juice product label, does not meet the requirements for "rich in" claims. Nutrient content claims that use the defined terms "rich in ," "excellent source," or "high," may be used in the labeling of a food only if the food contains 20 percent or more of the daily value (DV) of that nutrient per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)]. Such claims may not be made about a nutrient for which there is no established DV. There is no established DV for polysaccharides.
 
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 that 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 and to establish procedures to ensure that these violations do not recur. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
We offer the following comment on your dietary supplement product labels:
 
•  Your (b)(4) brand Cranberry Flavored Aloe Vera Liquid Herbal Supplement product should indicate the Daily Value has not been established for sugars. See 21 CFR 101.36(b)(2)(iii)(F).
 
We also offer the following comments on your conventional food product labels:
 
• The Aloe Vera Powder label does not meet the requirement in 21 CFR 101.105(j)(3) because it fails to use the term "net weight" when stating the net quantity of contents in terms of weight.
 
•  For the Aloe Vera Powder label, the weight in pounds or ounces should be followed by the metric equivalent in parenthesis [15 U.S.C. § 1453(a)(2) of the Fair Packaging and Labeling Act (FPLA)].
 
•  The net quantity of contents declaration of the Aloe Vera Juice label does not adhere to 21 CFR 101.105(k) because it is not expressed in the largest whole unit (gallons).
 
•  The nutrition information in the Aloe Vera Juice label does not meet formatting requirements in 21 CFR 101.9(d). For example, the heading "Nutrition Facts" is not set the full width of the label, several nutrients are not bolded, and a hairline is missing [21 CFR 101.9(d)(2)].
 
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. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection 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 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.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the above violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
Your written response should be sent to Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Thao Ta at (214) 253-5217.
 
Sincerely,
/S/
Amy Barringer
Acting Dallas District Director
 
___________________________________________
1 See Guidance for Industry: Ingredients Declared as Evaporated Cane Juice, available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRequlatorylnformation/LabelingNutrition/ucm181491.htm

Page Last Updated: 08/17/2016
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