WARNING LETTER
Nutreglo Products, LLC.
MARCS-CMS 557713 —
October 30, 2018
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Drugs
Recipient:
Recipient Name
Ms. Erma P. Melvin
Recipient Title
Owner/President
Nutreglo Products, LLC.
1862 NW 38th Ave.
Fort Lauderdale,
,
FL
33311-4119
United States
Issuing Office:
Office of Human and Animal Food Operations, Division IV East
466 Avenida Fernández Juncos
San Juan
,
PR
00901-3223
United States
(787) 729-8500
October 30, 2018
WARNING LETTER
19-HAFE4-WL-01 / CMS No. 557713
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Ms. Erma P. Melvin
Owner/President
Nutreglo Products, LLC
1862 NW 38th Ave.
Fort Lauderdale, Florida 33311-4119
Dear Ms. Melvin:
The United States Food and Drug Administration (FDA) inspected your facility located at 1862 NW 38th Ave, Fort Lauderdale, FL 33311-4119, from February 27, 2018, through March 26, 2018. The inspection revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR 111). These violations cause your dietary supplements 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.
In addition, FDA reviewed your website at the internet address www.nutregloproducts.com in September 2018 and has determined that you take orders there for your Blood & Internal Cleanser (Powder), Blood & Internal Cleanser (Capsules), Belly Fat Flush (Powder), Sugar Control Formula (Powder), Herbal X (Powder), and Bitter Tea (32 oz. Liquid) products. We have also reviewed the product labels collected during this inspection. The claims on your website and product labels establish that your Blood & Internal Cleanser (Powder), Blood & Internal Cleanser (Capsules), Belly Fat Flush (Powder), Sugar Control Formula (Powder), Herbal X (Powder), and Bitter Tea (32 oz. Liquid) products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Additionally, even if the labeling for your products did not bear therapeutic claims that make them drugs, certain of your products would be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on the FDA’s home page at
http://www.fda.gov
.
Unapproved New Drugs and Misbranded Drugs
Examples of some of the claims on your website at the internet address www.nutregloproducts.com and product labels that provide evidence that your products are intended for use as drugs include the following:
Blood & Internal Cleanser (Powder)
On the product label:
• “1 Shake a day removes . . . Parasites”
• Your ingredient list includes “Reum-Arthritis blend”
• “Internal Cleansing is an important factor in our lives, to help prevent sickness and deadly diseases and to aid with constipation, Kidney ailment, Headache…High blood pressure…Diverticulitis, Piles…Diabetes, Appendicitis…Diarrhea, Eczema, Parasite infection… Varicose Veins...”
On the web page https://nutregloproducts.com/shop?olsPage=products%2Fblood-internal-cleanser-1lb, next to an image of your product label showing that the product is intended to “remove waste [and] toxins”:
• “Detoxifying is an important factor in our lives to help prevent sickness and deadly diseases and to aid with constipation. Detoxifying, helps with waste, toxins and parasites. Waste hinders the body from absorbing nutrients, the body so badly needs to insure good health. The body’s inability to properly rid itself of toxic elements causes an unhealthy build up within the digestive organs (AKA High stomach). Waste build up can also cause toxins and bacteria to spread throughout the body, causing sickness or even death.”
Blood & Internal Cleanser (Capsules)
On the product label:
• “Removes . . . Parasites”
• “Lowers Cholesterol, Diabetes & High Blood Pressure. Aids with Varicose Veins, Infection, Appendicitis…Piles, Eczema, Cancer…Headaches, Constipation…”
Belly Fat Flush (Powder)
On the product label:
• “Eliminates Intestinal Parasite* Infection*= Gut Worms…Constipation…”
Sugar Control Formula (Powder)
On the product label:
• Your product name, “Sugar Control Formula,” in conjunction with a list of the “Signs of Diabetes,” implies that the product is intended for the treatment of diabetes.
Herbal X (Powder)
On the product label:
• “Arthritis…Joint Pains…High Cholesterol…High Blood pressure…Diabetes.”
Bitter Tea (32 oz. Liquid)
On the product label:
• “High Blood Pressure & Diabetes Care…”
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 sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d) and 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 Blood & Internal Cleanser (Powder), Blood & Internal Cleanser (Capsules), Sugar Control Formula (Powder), Herbal X (Powder), Belly Fat Flush (Powder), and Bitter Tea (32 oz. Liquid) products are intended for prevention or 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 these products safely for their intended purposes. Accordingly, your Blood & Internal Cleanser (Powder), Blood & Internal Cleanser (Capsules), Sugar Control Formula (Powder), Herbal X (Powder), Belly Fat Flush (Powder), and Bitter Tea (32 oz. Liquid) products fail to bear adequate directions for their intended use and, therefore, the products are 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)].
Adulterated Dietary Supplements
Our investigators observed the following significant violations of FDA’s CGMP requirements for dietary supplements found in 21 CFR 111, which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your Blood & Internal Cleanser (Powder), Blood & Internal Cleanser (Capsules), Belly Fat Flush (Powder), Sugar Control Formula (Powder), Herbal X (Powder), and Bitter Tea (32 oz. Liquid) products did not have therapeutic claims which make them unapproved new drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] for the reasons described below.
We have received your written response dated April 9, 2018, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on March 26, 2018. Our comments regarding the sufficiency of your corrective actions are noted below, after the applicable violation.
1. You failed to establish the required specifications for any point, step, or stage 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). Your firm receives dietary ingredient components at your facility that you blend together before sending to your contract manufacturer. Your contract manufacturer conducts further manufacturing operations, and then packages and labels the finished products and ships them back to your firm. You then repackage and label the products at your firm before distributing the products under your own label. At the time of the inspection, you had not established the following specifications:
• For components:
• An identity specification for each component [21 CFR 111.70(b)(1)];
• Component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)]; and
• 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 [21 CFR 11.70(b)(3)].
• Specifications to provide sufficient assurance that the capsule products you receive from your contract manufacturer for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f).
• Specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g), for the capsule dietary supplement products that you repackage and label.
• Note that once you have established component specifications, you must determine whether the specifications are met in accordance with 21 CFR 111.75(a). Once you establish specifications in accordance with 21 CFR 111.70(f), you must determine whether the specifications are met, in accordance with 21 CFR 111.75(e). Once you establish specifications in accordance with 21 CFR 111.70(g), you must determine whether the specifications are met, in accordance with 21 CFR 111.75(g).
We have reviewed your response dated April 9, 2018; however, we are unable to evaluate the sufficiency of your corrective actions since your response is silent regarding actions taken to address the above listed violation.
2. 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, and for approving and rejecting any reprocessing, as required by 21 CFR 111.103. During the inspection, you acknowledged that you have not established and followed such quality control procedures.
To the extent that another firm manufactures, packages, and/or labels your dietary supplements on your behalf that your firm then 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 the 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)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). You must implement quality control operations in accordance with 21 CFR 111.65 to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. In addition, your firm’s quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of your dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Further, your firm must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 21 CFR 111.140(b)(2)).
We have reviewed your response dated April 9, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states, “In case of equipment malfunction or poor quality of materials, quality control manager must examine the material and after careful examination the quality control officer will determine to reprocess or dispose.” Based on this limited information it is unclear whether you have established written procedures for quality control operations and whether you perform all required quality control functions, such as reviewing documentation from the manufacturers with whom you contract relating to how the products you release into commerce are manufactured and whether they conform to established specifications in order for your quality control operations to approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution.
3. 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, you did not prepare or follow an MMR for the blending, repackaging, and labeling operations conducted by your firm.
We have reviewed your response dated April 9, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response lists the requirements for a MMR identified in 21 CFR 111.210. However, you did not provide any written master manufacturing records with your response.
4. You failed to prepare a batch production record every time you manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, you did not prepare a batch production record for any of the batches of dietary supplement you manufactured.
We have reviewed your response dated April 9, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response indicates that you intend to prepare batch production records; however, you did not provide any batch production records with your response.
5. You failed to establish and follow written procedures to fulfill the requirements for product complaints, as required by 21 CFR 111.553, such as the requirement in 21 CFR 111.560 to review product complaints and investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications. Specifically, during the inspection, you told the investigator that you do not document and investigate product complaints. In establishing written procedures for product complaints, note that product complaint records must include the following: the name and description of the dietary supplement; the batch, lot, or control number of the dietary supplement, if available; the date the complaint was received and the name, address, or telephone number of the complainant, if available; the nature of the complaint including, if known, how the product was used; the reply to the complainant, if any; and findings of the investigation and follow‐up action taken when an investigation is performed (21 CFR 111.570(b)(2)(ii)(A)‐(F)).
We have reviewed your response dated April 9, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. Your response states, “After thorough examination and documentation of the return items, the quality control officer will determine, after duration of time whether this complaint is an isolated incident or a reoccurring situation.” However, your response does not include procedures for the review and investigation of a product complaint.
6. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, at the time of the inspection, you had not established written procedures for holding and distributing operations.
Once you have established written procedures for your holding and distributing operations, you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).
We have reviewed your response dated April 9, 2018; however, we are unable to evaluate the sufficiency of your corrective actions. You state that all finished products will be stored in a climate-controlled room, that out of town orders are securely packed and shipped via USPS, UPS, or FedEx, and that local deliveries are securely packed and delivered with a company vehicle. Your response fails to demonstrate that you have established written procedures for holding and distributing operations.
7. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, your “Return Products” procedure that you provided during the inspection does not include requirements for identification and quarantine of returned dietary supplements until quality control personnel conduct a material review and make a disposition decision, as required by 21 CFR 111.510.
Once you have established written procedures for your returned dietary supplements, you must make and keep records of such written procedures, as required by 21 CFR 111.535(b)(1).
We acknowledge your response, dated April 9, 2018; however, your response does not demonstrate that you have corrected this deficiency. Your response stated the process that your firm will employ when receiving returned dietary supplement products but did not include the associated written procedure or monitoring documents.
Misbranded Dietary Supplements
Even if your products did not have therapeutic claims that make them unapproved new drugs, your products are misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343], as follows:
1. Your Blood & Internal Cleanser Powder, Belly Fat Reducer+, and Bitter Tea products are misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, FDA collected and analyzed samples of your Blood & Internal, lot number GL BNIC-B#00123; Belly Fat Reducer, lot number MBFF-B#46; and Bitter Tea, lot number MOR-B#009, products to determine whether the nutrition information on your Supplement Facts panels accurately reflects the nutrient content of the products. Sample analysis findings were as follows:
• Your Blood & Internal Cleanser Powder label declares an iron content of 6 milligrams (mg) per serving. In accordance with 21 CFR 101.9(g)(4)(ii), for naturally occurring nutrients such as the iron in your product, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. Two analyses that FDA performed found the product to contain only 67.2% (4.36 mg, original analysis) and 69% (4.47 mg second analysis) of the declared amount. The declared amount of iron on your product label is false and misleading. The analytical worksheets for this product detailing the testing results (sample number 1023230) are enclosed.
• Your Belly Fat Reducer+ label declares a Vitamin B6 content of 50 mg per serving. In accordance with 21 CFR 101.9(g)(4)(ii), for naturally occurring nutrients such as the Vitamin B6 in your product, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. The two analyses that FDA performed found the product to contain only 3.8% of the declared amount (1.9 mg, original analysis) and 0.2% of the declared amount (.95 mg, second analysis) of Vitamin B6. The declared amount of Vitamin B6 on your product label is false and misleading. The analytical worksheets for this product detailing the testing results (sample number 1044411) are enclosed.
• Your Bitter Tea label declares a Vitamin C content of 37 mg per serving. In accordance with 21 CFR 101.9(g)(4)(ii), for naturally occurring nutrients such as the Vitamin C in your product, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. The two analyses that FDA performed found the product to contain only 1.4% of the declared amount (.52 mg, original analysis) and 0.1% of the declared amount (.04 mg, second analysis) of Vitamin C. The declared amount of Vitamin C on your product label is false and misleading. The analytical worksheets for this product detailing the testing results (sample number 1044412) are enclosed.
Furthermore, your Blood & Internal Cleanser Powder product declares “This Product is Registered as a Dietary Supplement.” This statement is misleading because dietary supplement products are not registered with the FDA. Finally, your Belly Fat Reducer+ product displays a photo showing a pomegranate and pineapple; this photo is misleading because it suggests that the product contains pomegranate and pineapple, but these ingredients are not listed in the ingredient list.
2. Your Blood & Internal Cleanser Powder, Blood and Internal Cleanser Capsules, Belly Fat Flush+, Sugar Control Formula, Belly Fat Reducer+, HerbalX, and Bitter Tea products are misbranded within the meaning of section 403(e)(1) [21 U.S.C. § 343(e)(1)] in that each product label does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
3. Your Blood & Internal Cleanser Powder, Belly Fat Reducer+, Belly Fat Flush+ and Sugar Control Formula products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.§ 1453(a)(2) of the Fair Packaging and Labeling Act. Specifically, for your Blood & Internal Cleanser (powder) and Belly Fat Reducer+ products net quantity of contents must be displayed in both metric (grams, kilograms, milliliters, liters) and U.S. Customary System (ounces, pounds, fluid ounces) terms. Further, your Belly Fat Flush+ and Sugar Control Formula products we also note that the term “NW” on the labels which is not an acceptable term to be used in the declaration of the net quantity of contents in accordance with 21 CFR 101.7(j)(3).
4. Your Belly Fat Flush+, Sugar Control Formula, Belly Fat Reducer+, and Bitter Tea products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
5. Your Belly Fat Flush+, Blood & Internal Cleanser Powder, Blood & Internal Cleanser Capsules, Belly Fat Reducer+, Bitter Tea, and HerbalX products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each the product label fails 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, you stated to our investigator and indicated in your response Senna leaf powder is in an ingredient of your Belly Fat Flush+ product but this ingredient is not declared on the product’s label. In addition, your Blood & Internal Cleanser (capsules) product fails to declare the ingredients of the capsule itself. Finally, the following terms with the corresponding product are not the common or usual names of ingredients: cinchona (Sugar Control Formula and HerbalX products); ruta and horsetail parsley (Blood & Internal Cleanser (capsules) product); horny goat weed and trigonella (Belly Fat Reducer+ product); zinc (Bitter Tea product); “some proprietary blended ingredients” (HerbalX product); amino acid (Bitter Tea and Belly Fat Reducer+ products), and “herbal digestive aid”, “… blend” and hercampuri (Blood & Internal Cleanser (powder) product).
6. Your Belly Fat Flush+, Belly Fat Reducer+, HerbalX, and Bitter Tea products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on each label is not in accordance with 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Specifically, serving size must include the equivalent metric quantity in parentheses.
7. Your Blood & Internal Cleanser Powder, Blood & Internal Cleanser Capsules, Belly Fat Flush+, Sugar Control Formula, Belly Fat Reducer+, HerbalX, and Bitter Tea products are 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 on the labeling does not comply with 21 CFR 101.36. For example:
• Your Blood & Internal Cleanser Powder, Blood & Internal Cleanser Capsules, Belly Fat Flush+, Sugar Control Formula, Belly Fat Reducer+, HerbalX, and Bitter Tea products list dietary ingredients in the ingredient list whose information is not declared within the Supplement Facts panel, as required by 21 CFR 101.36(b)(3);
• Your Belly Fat Flush+, Belly Fat Reducer+, HerbalX and Bitter Tea products declare an amount of zero (0) for total carbohydrates, protein, sodium, and/or fats. Any (b)(2)-dietary ingredient (including their components) not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared in accordance with 21 CFR 101.36(b)(2)(i);
• Your Blood & Internal Cleanser Capsules product does not list the dietary ingredients contained in the proprietary blend formula as required by 21 CFR 101.36(c).
• Your Blood & Internal Cleanser Capsules declaration of 22.5 servings per container does not correlate with a serving size of 2 capsules and 90 capsules per container, as required by 21 CFR 101.36(b)(1)(ii);
• Your Blood & Internal Cleanser Powder, Belly Fat Flush+, Belly Fat Reducer+, HerbalX, and Bitter Tea product labels declare caloric amounts that do not correlate with the listed amounts of carbohydrate, fat and protein, as required by 21 CFR 101.36(b)(2)(i) and 21 CFR 101.9(c)(1)(i)(B);
• Your Belly Fat Flush+, Belly Fat Reducer+, HerbalX, and Bitter Tea products either declare no amount or an amount of total carbohydrate that does not correlate with the listed subcomponents of total carbohydrate per 21 CFR 101.9(c)(6);
• Your Belly Fat Flush+ lists an incorrect unit of measure for calcium per 21 CFR 101.9(c)(8)(iv);
• Your HerbalX product fails to list the quantitative amount of calcium per serving and the %DV for potassium, as required by 21 CFR 101.36(b)(2) and 21 CFR 101.36(b)(2)(iii), respectively. In addition, your Belly Fat Reducer+ product declares a quantitative amount of dietary fiber without the calculated percent of the Daily Value for fiber. The percent of the Daily Value for all (b)(2)-dietary ingredients declared must be listed in accordance with 21 CFR 101.36(b)(2)(iii).;
• The %DV appears to be incorrect for the quantitative amount per serving of the listed dietary ingredient in the respective product: iron (Blood & Internal Cleanser (powder) product); saturated fat and total carbohydrates (Belly Fat Flush+ product); dietary fiber (HerbalX product) and dietary fiber, iron, Vitamin C and Vitamin A (Bitter Tea product) per 21 CFR 101.36(b)(2)(iii)(B) and 21 CFR 101.9(c)(8)(iv).
8. Your Belly Fat Reducer+ and Bitter Tea products bear nutrient content claims, but the products do 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 food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in 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 label of your Bitter Tea product declares “Packed with Antioxidants,” but the claim does not meet the requirements to make such a claim. Nutrient content claims using the term “antioxidant” must comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that is the subject of the claim, as required by 21 CFR 101.54(g)(1), and these nutrients must have recognized antioxidant activity, as required by 21 CFR 101.54(g)(2). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), as required by 21 CFR 101.54(g)(3). Further, nutrient content claims using the term "antioxidant" must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)]. The antioxidant claim on your label does not indicate the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol. The use of a nutrient content claim that uses the term “antioxidant” but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(1)(A) of the Act.
9. Your Blood & Internal Cleanser Capsules, Belly Fat Flush+, Sugar Control Formula, Belly Fat Reducer+, HerbalX and Bitter Tea products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because each product does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(d) and (g).
10. Your Blood & Internal Cleanser Capsules, Belly Fat Flush+, Sugar Control Formula, Belly Fat Reducer+, HerbalX and Bitter Tea products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because each label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
11. Your Belly Fat Reducer+ product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains ingredients identified as “Ashwaganda (Indian Ginseng)” and “Eleuthero root, Siberian Ginseng”. These ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
The violations cited in this letter are not intended to be an all-inclusive list 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, including FDA regulations.
You should take prompt measures to correct all violations cited in this letter. Failure to promptly correct these violations may result in legal action by FDA 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 the 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 mean 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 reinspection 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, the FDA may assess fees to cover any reinspection-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 violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.
Your reply should be directed to: District Director, Food and Drug Administration, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Beira Montalvo, Compliance Officer, at (561) 416-1065, Ext. 1108, or via e-mail at
Beira.Montalvo@fda.hhs.gov
.
Sincerely yours,
/S/
Ramon A. Hernandez
District Director, San Juan District Office
and Program Division Director,
Office of Animal and Human Food Operations,
Division IV East
Content current as of:
01/15/2019
Regulated Product(s)
Drugs