The United States Food and Drug Administration (FDA) inspected your warehouse and distribution facility located at 1730 NW 79
th
Ave, Doral, Florida, from June 6, 2017, through July 14, 2017. Our inspection and review of your product labels identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations. You may find the FD&C Act and FDA regulations through links in the FDA’s home page at
http://www.fda.gov
.
Misbranded Drugs
Section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] defines “drug” as:
(A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure of any function of the body of man or other animals; and
(D) articles intended for use as a component of any articles specified in clause (A), (B), or (C).
A drug is deemed to be misbranded under section 502(f)(1) of the Act if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5 “Prescription drugs” within the meaning of section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)] are drugs that, because of their toxicity or potential for harmful effect, method of use, or collateral measures necessary to their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Thus, adequate directions for use cannot be written for prescription drugs so that a lay person can use them safely for their intended uses.
FDA collected a sample of your product, “Vegetal Vigra Special for men” (“Vegetal Vigra”). “Vegetal Vigra” is a “drug” within the meaning of section 201(g)(1)(B) and (g)(1)(C) of the FD&C Act because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and/or because it is an article intended to affect the structure or any function of the body of man or other animals. These intended uses are demonstrated by your product’s labeling and contents. The labeling for “Vegetal Vigra” collected during the inspection describes the following intended uses for the product:
- “Take one capsule orally 20 minutes before sexual intercourse. One capsule can last for 120 hours in (sic) action.”
- “For impotence”
- “Premature ejaculation”
- “Effective to enlarge the penis”
Additionally, FDA confirmed through laboratory analysis that a sample of your product “Vegetal Vigra” contained undeclared sildenafil, a phosphodiesterase type-5 (PDE-5) inhibitor that is the active pharmaceutical ingredient (API) in Viagra™, an FDA-approved prescription drug intended to treat erectile dysfunction. All PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer such drugs.
Due to the toxicity and other potential for harmful effect and the collateral measures necessary to its use, “Vegetal Vigra” is not safe for use except under the supervision of a licensed practitioner. In addition, “Vegetal Vigra” is intended for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. For these reasons, it is a prescription drug within the meaning of section 503(b)(1)(A) of the Act, and adequate directions cannot be written so that a layman can use it safely for its intended uses. Consequently, the labeling of this drug fails to bear adequate directions for its intended uses. “Vegetal Vigra” is not exempt from the requirements of section 502(f)(1) of the FD&C Act by regulations issued by FDA (see, e.g., 21 CFR 201.115). For these reasons, “Vegetal Vigra” is a misbranded drug under section 502(f)(1) of the FD&C Act.
Additionally, under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act [21 U.S.C. § 321(n)], provides that, in determining whether an article's labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations . . ..” The labeling for “Vegetal Vigra” does not declare that it contains sildenafil. The failure to disclose the presence of sildenafil in the product’s labeling renders “Vegetal Vigra” misbranded under section 502(a) of the FD&C Act. The presence of undeclared PDE-5 inhibitors contained in your product may pose serious health risks because consumers with underlying medical issues may take this product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The failure to disclose the presence of sildenafil renders your product’s labeling false or misleading. Therefore, “Vegetal Vigra” is a misbranded drug under section 502(a) of the FD&C Act.
The undeclared sildenafil in “Vegetal Vigra” also causes this product to be a misbranded drug under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] in that the product’s labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with the use of PDE-5 inhibitors. Consumers who use “Vegetal Vigra” would be unaware of the presence of the undeclared drug ingredient and placed at risk for its associated adverse events. We note that FDA has reviewed and approved products containing PDE-5 inhibitors and determined that such products require warning information pursuant to 21 C.F.R. 201.57. This warning information includes the potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. The receipt in interstate commerce of any drug that is misbranded is a prohibited act under section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].
Adulterated Dietary Supplements
During our inspection of your facility, our investigator observed significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21 Code of Federal Regulations Part 111 (21 CFR 111), which render your dietary supplement products adulterated under section 402(g)(1) of the FD&C Act [21 U.S.C. § 342(g)(1)] for the reasons described below. Our investigator’s observations were noted on a Form FDA 483, Inspectional Observations, issued to you on July 14, 2017. We received your firm’s undated response on August 7, 2017, to the observations noted in the Form FDA 483. We address each response below in relation to the relevant violation noted in the Form FDA 483. The significant violations documented during the inspection include, but are not limited to, the following:
1. Your firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, at the time of the inspection, you did not have any written procedures for fulfilling the requirements related to returned dietary supplements.
Once you establish such procedures, you must keep records of written procedures for returned dietary supplements and records of any material review and disposition decision for returned dietary supplements, as required by 21 CFR 111.535(b).
We have reviewed your undated response received by FDA on August 7, 2017, in which you state that you intended to implement new procedures by 4th Qtr. of 2017. The implementation of your corrective actions will be evaluated during our next inspection.
2. Your firm failed to 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). In accordance with 21 CFR 111.83(b), the reserve samples must:
- be held using the same container‐closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)];
- be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)];
- be retained for at least (1) year past the shelf life date (if shelf life dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(3)]; and
- consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specification [21 CFR 111.83(b)(4)].
Specifically, your firm did not ensure reserve samples are taken for your Vivaben dietary supplement product which is received and distributed by your firm.
We have reviewed your undated response received by FDA on August 7, 2017, that states that you will implement a hold and reserve sample procedure and program for all of your dietary supplement products by the 1st Qtr. of 2018. We will verify the adequacy of your proposed corrective action during our next inspection.
3. Your firm 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. Specifically, at the time of inspection, your firm had not established written procedures for the responsibilities of quality control operations.
Once you have established your quality control written procedures, you must implement quality control operations in your holding operations, as required by 21 CFR 111.65, and you must implement a system of production and process controls to ensure the quality of the dietary supplements, as required by 21 CFR 111.55.
We have reviewed your undated response received by FDA on August 7, 2017, in which you state that new procedures were to be developed by 4th Qtr. of 2017. We are unable to evaluate the adequacy of your corrective action because you did not provide documentation to show that you have established the required written procedures.
As a distributor that contracts with a manufacturer to manufacture, package, or label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 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 supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements. In particular, the FD&C 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). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations 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 111.105). Further, you 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 111.140(b)(2)).
Misbranded Dietary Supplements
During our inspection, we collected the labeling of your dietary supplement products, including “Vivaben Softgels” (Menopause Formula), and “Cardiovid Plus” products. After further review of the labels, we have determined that these products are misbranded foods under section 403 of the FD&C Act (21 U.S.C. § 343) in that the labels for these products do not comply with the labeling requirements in 21 CFR Part 101.
1. Your Cardiovid Plus product is misbranded within the meaning of section 403(q)(1)(A) of the FD&C Act [21 U.S.C. §343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b). For example, the Cardiovid Plus directions of use suggest the consumer take one (1) or two (2) softgels daily, but the serving size lists one (1) softgel. The serving size listed should be two (2) softgels.
2. Your Cardiovid Plus product is misbranded within the meaning of section 403(q)(5)(F) of the FD&C Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutritional information on the labeling of your product does not comply with 21CFR Part 101.36. For example:
- Your Cardiovid Plus product label fails to declare the % DV for the (b)(2)-dietary ingredients and fails to state “Daily Value not established” for the (b)(3)-dietary ingredients in accordance with 21 CFR 101.36(b)(2)(iii) and 101.36(b)(3)(iv).
- Your Cardiovid Plus product label fails to declare the EPA, DHA, vitamin B-12, folic acid, and vitamin B6 dietary ingredients within the Supplement Facts label.
- Your Cardiovid Plus product label declares total carbohydrates, protein, and sodium. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in 21 CFR 101.9(c), shall not be declared.
3. Your Vivaben Softgels (Menopause Formula) and Cardiovid Plus products are misbranded within the meaning of section 403(i)(2) of the FD&C 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 101.36 and 21 CFR 101.4. For example,
- Your Vivaben Softgels (Menopause Formula) product’s Makers Nutrition “specification” sheet lists soybean oil, but the product label fails to declare the common or usual name of this dietary ingredient.
- Your Cardiovid Plus product label declares the dietary ingredient fish oil, but fails to declare the specific common or usual name of each type of fish used in accordance with 21 CFR 101.4(b)(14).
- Your Cardiovid Plus product’s InnovaGel certificate of analysis for batch number 1701045 lists the ingredient dicalcium phosphate, but the product label fails to declare the common or usual name of this dietary ingredient.
4. Your Vivaben Softgels (Menopause Formula) is misbranded within the meaning of section 403(k) of the FD&C Act [21 U.S.C. § 343(k)] in that the product contains artificial coloring and the label fails to state that fact. Specifically, your Vivaben Softgels (Menopause Formula) product’s Makers Nutrition “specification” sheet indicates the color green for the softgels, but the product label fails to declare any color additive ingredients. The label of a food to which any coloring has been added must declare the coloring in the statement of ingredients in the manner specified in 21 CFR 101.22(k)(1) and 10.22(k)(2).
5. Your Vivaben Softgels (Menopause Formula) product label is misbranded within the meaning of section 403(s)(2)(C) of the FD&C Act [21 U.S.C. § 343(s)(2)(C)] because the 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).
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the FD&C Act and its implementing regulations. We advise you to review your website, product inventory, product labels and other labeling for your products to ensure that the claims you make for your products or the presence of undeclared active pharmaceutical ingredients do not cause your products to violate the FD&C Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action by FDA without further notice. The FD&C Act authorizes the seizure of illegal products and injunctions against the manufacturers and/or distributors of those products [21 U.S.C. §§ 332 and 334].
You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. You should include any documentation necessary to show that correction has been achieved. 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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Section 743 of the FD&C 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 FD&C 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 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.
