Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
466 Fernández Juncos
San Juan, Puerto Rico 00901-3223
Telephone: (787) 729-8500FAX: (787) 729-8826
January 20, 2016
VIA UNITED PARCEL SERVICE
NEXT DAY – SIGNATURE REQUIRED
Ms. Mayra Rodriguez
Majopa Industries, Corp.
P.O. Box 1671
Guayama, PR 00785
Dear Ms. Rodriguez:
The Food and Drug Administration (FDA) conducted an inspection of your facility, located at 62 South Ashford Street, Guayama, Puerto Rico from July 30 to August 11, 2015. During our inspection, we collected labels for your Graviola Extract product. Your product label includes the address for the website, www.graviolagroup.com, which you identified as being operated by your product distributor for U.S. and foreign countries. We have determined that this website is labeling within the meaning of section 201(m) of the Act for your Graviola Extract product. We reviewed this website in October 2015. The claims on your product label and the www.graviolagroup.com website establish that your product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 21(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. In addition, the inspection showed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, found in Title 21 of the Code of Federal Regulations Part 111 (21 CFR Part 111). These violations render dietary supplements that are manufactured in your facility adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)], in that such products were prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. You may find the Act and related regulations through links on our website, at www.fda.gov.
Unapproved New Drug/Misbranded Drug
Specific examples of claims in your product labeling that promote your product as a drug include, but no limited to:
In your finished product label:
On the website www.graviolagroup.com:
- “Watch real cancer patients testimonials about the use of Graviola extract and the benefits that it provided…”
- “Is Graviola a Cancer Cure?...used to combat…depression…used to the treatment of worms and parasites…to cool fevers…crushed seeds are used against parasites internal and external, head lice, and worms, the roots are considered a sedative…Important information about Cancer…one of the most important discoveries related to cancer is that of the parasites…All cancer patients are infected with parasites…Dr. Hulda Clark book "The Cure for All Cancers" (The Cure For all cancers) discovered that cancer and parasite are related…The book concluded…all cancer patients are infected with parasites. Parasites…which the body simply is not any defense against cancer and succumbed to the attack of the cancer cells...herbal treatment by Dr. Clark where have completely stopped progress of cancer in their bodies with herbal treatment as said in the book...”“Acetogeninas…CANCER…(Cancer-related term)…Cancer cell resistance to chemotherapy Drugs: Mechanism of Action
Some cancer cells develop multidrug resistance (MDR)…capable of expelling anticancer agents (chemotherapy drugs) out of the cell…The process of expelling anticancer agents…”
- “Cancer and Chemotherapy…One of the most common treatments is chemotherapy…The cancer patient enters an exorbitant cost between chemotherapy…The Graviola extract can be used as a natural supplement in combination with the chemotherapy…”
- “Cancer and the Mood…Like others diseases there is a close relationship between…cancer…cancer…To improve the cancer…in the formation of a physiological cancer…”
Your Graviola Extract 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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, 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 Graviola Extract product 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 Graviola Extract product fails to bear adequate directions for its intended use and, therefore, your Graviola Extract 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)].
Adulterated Dietary Supplement
The website www.graviolagroup.com included on the product label refers to this product as a “dietary supplement;” therefore, we inspected your firm for compliance with the CGMP regulation for dietary supplements found in 21 CFR Part 111. We note that your product label does not identify the product as a dietary supplement. If you intend to market your product as a dietary supplement, it must comply with the applicable statutory and regulatory requirements, including 21 CFR Part 111 and the nutrition labeling requirements under 21 CFR 101.36. Based on FDA’s observations during the inspection of your facility, if this product were a dietary supplement, it would be adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because it has been prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements found in 21 CFR Part 111.
We have received your written response, dated August 17, 2015, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on August 11, 2015. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
The following serious violations of the CGMP for dietary supplements were observed during our inspection:
1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of each dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
We acknowledge your response letter dated August 17, 2015, to the Form FDA 483, and find your response to be inadequate. For example, your response included a blank document titled “Test and Retention Sample Log Graviola Extract”, but this document does not include finished product specifications nor does it state if the samples referenced are regarding finished product testing. This same document was provided to our investigator during the inspection and was identified by you as a batch production record (BPR).
2. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205(a). Our investigator found that you did not prepare or follow an MMR for any of your batches manufactured.
We acknowledge your response letter dated August 17, 2015, to the Form FDA 483, and find your response to be inadequate. For example, the document titled “Master Manufacturing Plan” for “Graviola Extract” failed to include the following requirements:
a. The strength, concentration, weight or measure of each dietary ingredient for each batch size [21 CFR 111.210(a)]
b. A complete list of components to be used [21 CFR 111.210(b)]
c. An accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)].
d. The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement
e. A statement of any intentional overage amount of a dietary ingredient
f. A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]
g. A representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)]
h. Written instructions, including specifications, for each 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 MMR [21 CFR 111.210(h)(1)]
i. Procedures for sampling and a cross reference to procedures for tests or examinations [21 CFR 111.210(h)(2)]
3. You failed to establish specifications for your dietary supplement labels, as required by 21 CFR 111.70(d). Specifically, our investigator found that you do not have label specifications for your Graviola Extract product.
We acknowledge your response letter dated August 17, 2015, to the Form FDA 483, and find your response to be inadequate. Your response did not include procedures regarding labeling and packaging specifications which ensure finished product labeling and packing are safe and suitable and that finished products are properly labeled.
4. You failed to establish 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 or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, your firm does not have written procedures for quality control operations.
We acknowledge your response letter dated August 17, 2015, to the Form FDA 483, and find your response to be inadequate. Your response did not address quality control operations regarding dietary supplement manufacturing performed by your firm.
5. You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b). Specifically, you failed to establish component specifications for identity, purity, strength, composition, and limits on contaminants for your graviola extract dietary supplements. Please note that once you have established the identity specifications for each component, you must verify that the specifications are met in accordance with 21 CFR 111.75(a)(1)(i) and 21 CFR 111.75(a)(2), and you must make and keep records in accordance with 21 CFR 111.95(b).
We acknowledge your response dated August 17, 2015, to the Form FDA 483. We cannot assess the adequacy of your response because sufficient evidence was not provided to demonstrate specifications for identity, purity, strength, composition, and limits on contaminants have been established for all components used in the manufacture of graviola extract dietary supplement products.
6. Your firm failed to prepare a batch production record (BPRs) every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255(a) Specifically, you stated to our investigator BPRs were not utilized by your firm during the manufacturing of any of the graviola extract dietary supplement products produced by your firm.
We acknowledge your response letter, dated August 17, 2015, to the Form FDA 483, and find your response to be inadequate. The document titled “Test and Retention Sample Log Graviola Extract” which was included in your response was the same document identified by yourself during the inspection as a BPR and provided a copy of this BPR to our investigator. This document does not include complete information relating to the production and control of each batch. Also, each batch record must accurately follow the appropriate MMR for each unique formulation of dietary supplement you manufacture and for each batch size.
7. Your firm also failed to establish and follow written procedures for the following:
a. Personnel [21 CFR 111.8]
b. Physical Plant and Pest Control [21 CFR 111.16]
c. Packaging and Labels [21 CFR 111.153]
d. Manufacturing Operation [21 CFR 111.353]
e. Holding and Distributing [21 CFR 111.453]
f. Product Complaints [21 CFR 111.553]
We acknowledge your response letter, dated August 17, 2015, to the Form FDA 483. Your response cannot be evaluated because of a lack of supporting documentation.
Also, in your response letter dated August 17, 2015, to FDA-Form 483, Inspectional Observations, you state that you initiated a voluntary recall, and you temporarily ceased distribution of Graviola Extract locally in Puerto Rico and through the Graviola Group website until the recall is terminated and your reconditioning proposal is revised. The reconditioning proposals submitted to the agency which address the label for your Graviola Extract product was reviewed and deemed inadequate, see e-mail from Ms. Wanda Torres, Recall Coordinator, dated 01/19/16. Please continue to provide updates regarding the voluntary recall and any further reconditioning proposals. In addition, we note that your reconditioning proposals did not include any corrective actions regarding the www.graviolagroup.com website disease claims related to your Graviola Extract product.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determining 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Your written response should be directed to the Food and Drug Administration, attention: Carlos A. Medina, Compliance Officer, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Medina at (787) 729-8617 or via email at email@example.com.
San Juan District
Mr. Edwin Cardona
375 Arboles de Montehiedra St
San Juan, PR 00926
This page was posted on March 28, 2019.