WARNING LETTER
Let's Talk Health, Inc.
MARCS-CMS 576771 —
August 06, 2019
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Mr. James L. Cartmill
Recipient Title
President
Let's Talk Health, Inc.
2411 Fenton St. Ste 102
Chula Vista
,
CA
91914
United States
Issuing Office:
Division of Human and Animal Food Operations West V
1431 Harbor Bay Parkway
Alameda
,
CA
94502-7070
United States
WARNING LETTER
August 6, 2019
WL# 576771
Dear Mr. James L. Cartmill:
The United States Food and Drug Administration (FDA) inspected your facility located at 2411 Fenton St. Ste 102, Chula Vista, CA on February 6, 8, and 11, 2019. Based on the inspection, a review of the product labels and promotional literature collected, and a review of your website and blog, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and related regulations through links on FDA's home page at www.fda.gov.
We have received your written response dated March 4, 2019, concerning our investigator’s observations noted on the FDA-483, Inspectional Observations, issued to you on February 11, 2019. 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.
Unapproved New Drugs and Misbranded Drugs
We reviewed your website at www.letstalkhealth.com in June 2019 and have determined that you take orders there for the products Cardio Advantage Plus, Urine-Eze, Re-Lev-It, Liposomal Symplex P, Liposomal Vitamin C, Melatonin, Liposomal B-Complex, Liposomal Curcumin, Liposomal Glutathione, and VariGone. We also reviewed your blog at blog/letstalkhealth.com in June 2019, which links to your website at
www.letstalkhealth.com, and following the February 2019 inspection, we reviewed additional materials collected during the inspection, including your product labels and brochures that accompany the product.
The claims on your website, blog, product labels, and brochures establish that your Cardio Advantage Plus, Urine-Eze, Re-Lev-It, Liposomal Symplex P, Liposomal Vitamin C, Melatonin, Liposomal B-Complex, Liposomal Curcumin, Liposomal Glutathione, and VariGone 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.
Examples of the claims that provide evidence that your products are intended for use as drugs include the following:
1. Cardio Advantage Plus [which contains ingredients such as Lycopene, Ethelene-Diamine-Tetra-Acetic Acid (EDTA), Carnitine, and Folic Acid] –
a. From your website:
i. “ . . . Cardio Advantage Plus . . . [contains] 16 nutrients that are clinically proven to help prevent the changes in the blood vessels that can result in heart disease.”
ii. “Cardio Advantage Plus assists in changing the biochemistry of the body so that the harmful changes that have already taken place can be slowly, but surely, REVERSED naturally without prescription drugs!”
iii. “Cardio Advantage Plus was designed to assist the body in overcoming the symptoms of heart disease by actually restoring the flow of blood to the damaged areas and helping to prevent future plaque formation.”
iv. “The nutrients contained in Cardio Advantage Plus are a proprietary blend of nutrients specially chosen . . . to assist the body in controlling blood pressure.”
v. “[L]ycopene may help prevent cardiovascular disease, diabetes, cancer and osteoporosis. Lycopene has even been found to have an inhibitory effect on cataract development and some rare cancer cells. As a powerful antioxidant, lycopene helps neutralize harmful free radicals, which are implicated in cancer, heart disease, macular degeneration, and other age-related illnesses. . . . [L]ycopene may help prevent cardiovascular disease, diabetes, cancers of the prostate, lung, stomach, pancreas, breast and colon as well as osteoporosis.”
vi. “There are literally thousands of studies available supporting [EDTA’s] ability to restore cardiovascular function. EDTA has been show . . . to relieve symptoms associated with atherosclerotic disease. . . . [EDTA] support[s] the removal of undesirable calcium and other minerals that promote plaque formation, blood clotting, and atherosclerosis. . ..
vii. “Carnitine . . . [has been used to show significant improvement in those with] mild cognitive impairment.”
viii. “Folic acid. . . [can] lower the rate of colon cancer by 71% when taken regularly as a supplement!”
b. The brochure that you enclose with shipped with customer products contains evidence of intended use in the form of a personal testimonial recommending or describing the use of Cardio Advantage Plus for the cure, mitigation, treatment, or prevention of disease: “We are on our third bottle and my husband’s blood pressure has dropped by 10+ points and my LDL cholesterol has also dropped.”
2. Urine-Eze (from your website) –
a. Your website includes the following customer review, which you reviewed and selected for posting on your website: “Get a lot of UTI’ as of late and this product is super good to fight them off.”
b. “Naturally Inhibits Bacterial Growth”
c. “[A]ssists in prohibiting bacteria from adhering to the urinary tract lining. In addition, vitamins A and C [ingredients in the product] help to heal the irritated and inflamed areas.”
3. Re-Lev-It (from your website) –
a. Your website includes the following customer review, which you reviewed and selected for posting on your website: “I’ve had RA for three years and three months ago months ago my doctor took me off Enbrel and methotrexate because I’m in stage three kidney disease. After 4-6 weeks my symptoms were so bad it was difficult to get out of bed and I couldn’t use my right hand and was put on pain medication. After being told by another person about [Re-Lev-It] I ordered it. Much to my delight I am almost symptom free and off pain meds completely!!!!”
b. “Chiropractor Recommended for Inflammation”
c. “All-Natural Pain Support”
d. “anti-inflammatory”
e. “reducing inflammation and pain”
f. “Dramatic results have been reported for people suffering from the pain associated with arthritic, rheumatism, lower back pain muscle pain, neuralgia, and migraines.”
g. “. . . DLPA [an ingredient in Re-Lev-It] . . . has a strong antidepressant action to help relieve anxiety.”
h. “Nattokinase [an ingredient in Re-Lev-It] is commonly used orally for cardiovascular diseases including heart disease, high blood pressure, high cholesterol, stroke, chest pain (angina), deep vein thrombosis (DVT), “hardening of the arteries" (atherosclerosis), hemorrhoids, varicose veins . . . and peripheral artery disease (PAD).”
i. “Boswelia Extract [an ingredient in Re-Lev-It, is] used for osteoarthritis, rheumatoid arthritis, joint pain (rheumatism), bursitis, and tendonitis. Other uses include ulcerative colitis, abdominal pain, asthma, hay fever . . . syphilis . . . and cancer.”
4. Liposomal Symplex P (from your website)-
a. Your website includes the following customer review, which you reviewed and selected for posting on your website: “This product has halted and improved my mother’s Parkinson’s.”
b. “Assists in Naturally Reducing Symptoms of Neuromuscular Conditions”
c. “Some of the signs of CoQ-10 [an ingredient in Liposomal Symplex P] deficiency are muscle aches and pains, liver dysfunction and neuro-muscular deterioration.”
5. Liposomal Vitamin C – Your website provides a link to your Let’s Talk Health blog article titled “Link Between Vitamin C and Combating Cancer,” which includes statements such as, “The importance of Vitamin C in combating cancer is of paramount importance.”
6. Melatonin and Liposomal B-Complex – Your blog titled “Lack of Sleep Linked to Cancer & Alzheimer’s Disease” recommends your Melatonin and Liposomal B-Complex products to prevent cancer and Alzheimer’s.
7. Re-Lev-It & Liposomal Curcumin – Your blog titled “Inflammation Triggers Chronic Disease,” which links directly to and from your website, touts the risks of chronic inflammation in the development of diseases such as Allergy, Alzheimer’s, Anemia, Ankylosing Spondylitis, Autism, Congestive heart Failure, Guillain-Barre, Heart Attack, Multiple Sclerosis, and Stroke, and asserts that “[t]he solution to relieving inflammation can be found in a brilliant yellow spice common in Indian cuisine that you can find in any grocery store. This spice is Tumeric, which has been used for centuries to treat wounds, infections, colds, and liver disease. Curcumin is the main active ingredient in turmeric. . . . Liposomalized curcumin is absorbed at substaintially [sic] higher rate.” [Curcumin is an ingredient in Re-Lev-It and Liposomal Curcumin.]
8. Liposomal Glutathione – Your blog titled, “The Vital Importance of Glutathione,” which links directly to and from your website, asserts that glutathione supplementation can be used to “combat a wide number of ailments including: Parkinsons, Heart, Kidney, and Liver Diseases, Cancer, Alzheimer’s, . . . Autoimmune Illnesses, Arthritis, Asthma.”
9. VariGone (from your website) –
a. Your website includes the following customer reviews, which you reviewed and selected for posting on your website:
i. “Works for getting rid of hemorrhoids too.”
ii. “Even the pool of broken veins and discoloration around my ankles has improved immensely.”
b. “Assist Elimination of Broken Veins and Discoloration” . .”
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), 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 Cardio Advantage Plus, Re-Lev-it, Liposomal Symplex P, Liposomal Vitamin C, Melatonin, Liposomal B-Complex, Liposomal Curcumin, and Liposomal Glutathione products are 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 products safely for their intended purposes. Accordingly, your Cardio Advantage Plus, Re-Lev-it, Liposomal Symplex P, Liposomal Vitamin C, Melatonin, Liposomal B-Complex, Liposomal Curcumin, and Liposomal Glutathione 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
Your dietary supplements products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they products have been prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practice (CGMP) regulations for dietary supplements found in Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Additionally, even if the product labeling for your Cardio Advantage Plus, Urine-Eze. Re-Lev-It, Liposomal Symplex P, Liposomal Vitamin C, Melatonin, Liposomal B-Complex, Liposomal Curcumin, Liposomal Glutathione, and VariGone did not have therapeutic claims which make these products unapproved new drugs and/or misbranded drugs, these products would still be adulterated dietary supplements within the meaning of section 402(g)(1) of the Act because the products have been prepared, packed, or held under conditions that do not meet the CGMP regulations in 21 CFR Part 111.
Your significant violations are as follows:
1. 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you informed our investigator that you do not have written procedures for responsibilities of the quality control operations and that you do not perform or document all required quality control operations, such as material review and disposition decisions.
As a distributor that contracts with a manufacturer to manufacture, package, and/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)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements. 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)). 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 with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
You must implement a system of production and process controls that covers all stages of your labeling and 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 supplement and that the dietary supplement is packaged and labeled as specified in a master manufacturing record, as required by 21 CFR 111.55. You must establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 101.103. The quality control personnel must ensure that your operations ensure the quality of the dietary supplement and that the dietary supplement is labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Furthermore, you must have documentation of the quality control personnel review and approval for release or rejection for any labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and 111.140(b)(2). However, you provided no documentation of the quality control review to ensure the quality of the dietary supplements you distribute and that they are packaged and labeled according to the master manufacturing record.
These are repeat violations from the previous inspection of your firm in 2016.
We acknowledge your response, dated March 4, 2019, in which you state that you are including the whole process of documenting quality control material review and disposition decisions that will include a quality control, date and time of disposition with a required signature in the MOU agreement with your contract manufacturer. You state further that you will be including written procedures, specifications, master manufacturing records, batch records, ensuring reserve samples are collected, receiving records, packaging, labeling, returned dietary supplements, and product complaints in your scope of work through your MOU agreement with your contract manufacturer, and that you will complete corrective actions within 90 days. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that you made a similar statement in a correspondence to FDA dated May 23, 2016, in which you responded to the same citation by stating that you had made an agreement to transfer all quality control operations to your contract manufacturer, but we saw no evidence of such corrective action during the February 2019 inspection.
2. Your firm 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 told investigators that you label certain dietary supplement products at your facility but do not have an MMR for those products you label.
This is a repeat violation from the previous inspection of your firm in 2016.
We acknowledge your response, dated March 4, 2019, in which you state you will incorporate your contract manufacturer’s MMRs for implementation at your location. Your response indicates that you are in the process of creating and executing a Memorandum of Understanding (MOU) with your contract manufacturer and anticipate completing your MMR in no less than 90 days. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that you promised corrective action in a letter to FDA dated May 23, 2016, relating to the same citation, in which you stated that you had made an agreement to transfer all manufacturing responsibilities to your contract manufacturer, including the responsibility to prepare manufacturing records for each unique formulation of a dietary supplement, but we saw no evidence of such corrective action during the February 2019 inspection.
3. 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). Specifically, you told investigators that you do not collect and hold reserve samples of the product that is packaged and labeled in your facility.
We acknowledge your response dated March 4, 2019, in which you state that you will create in your standard operating procedures (SOP) an agreement with your contract manufacturer utilizing “best practices” for accomplishing the requisite storage of reserve samples at a mutually agreed location specifying specific climate control and other environmental conditions; however, we are unable to evaluate the adequacy of your response because you did not provide the MOU agreement or SOP documenting your corrective actions.
4. Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required under 21 CFR 111.553, and for the review and investigation of product complaints, as required under 21 CFR 111.560. Specifically, during the inspection your firm did not have written procedures or SOPs for documenting, receiving, investigating and reviewing product complaints.
This is a repeat violation from the previous inspection of your firm in 2016.
We acknowledge your response dated March 4, 2019, which states that that you do not have a written policy for step by step processes but that you review and document complaints in conjunction with your contract manufacturer. Your recent response indicates that you are in the process of creating and executing a Memorandum of Understanding (MOU) with your contract manufacturer and anticipate completing your product complaint SOPs in no less than 90 days. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that in a communication to FDA dated May 23, 2016, you stated that you were going to establish written procedures regarding reviewing and investigating product complaints and adverse event reporting, but we saw no evidence of such corrective actions during the February 2019 inspection.
5. Your firm failed to establish and follow written procedures to fulfill the requirements for dietary supplement returns, as required by 21 CFR 111.503. Specifically, you told our investigators that you did not have written procedures for returned dietary supplements. Once you have established written procedures for returned dietary supplements, you must make and keep records of such procedures and related investigations, as required by 21 CFR 111.535.
This is a repeat violation from the previous inspection of your firm in 2016.
We acknowledge your response date March 4, 2019, in which you state that you do not have a written policy that provides a step‐by‐step process for returned dietary supplement products but that you will include the process for documenting returns in an MOU with your contract manufacturer. Your recent response indicates that you are in the process of creating and executing an MOU with your contract manufacturer and anticipate completing your product return SOPs in no less than 90 days. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that in a communication to FDA dated May 23, 2016, you stated that you were going to establish written procedures to document the handling of returned dietary supplements, in conjunction with your contract manufacturer, but we saw no evidence of such corrective actions during the February 2019 inspection.
6. Your firm failed to establish and follow written procedures for fulfilling the requirements for labels and product that you receive for packaging or labeling as a dietary supplement, as required under 21 CFR 111.153. Specifically, you told our investigators that you did not have a written procedure for receiving labels, finished dietary supplements or unlabeled dietary supplements. Once you establish such procedures, you are required to make and keep records of such procedures and your compliance with them, as required by 21 CFR 111.180.
This is a repeat violation from the previous inspection of your firm in 2016.
We acknowledge your response date March 4, 2019, in which you state that you currently go through a rigorous label approval process with your contract manufacturer before a purchase order may be submitted to them. You state that you will memorialize that process in your MOU agreement to have this process in written format included in your Standard Operating Practices. Your recent response indicates that you are in the process of creating and executing a Memorandum of Understanding (MOU) with your contract manufacturer and anticipate completing your product packaging and labeling SOPs in no less than 90 days. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that in a communication to FDA dated May 23, 2016, you stated that you had made an agreement to transfer all label specifications and labeling to your contract manufacturer, but we saw no evidence of such corrective actions during the February 2019 inspection.
7. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you told our investigators that you do not have written procedures for holding and distribution of your dietary supplements. Once you have established these procedures, you must make and keep records required for holding and distributing operations, as required by 21 CFR 111.475.
This is a repeat violation from the previous inspection of your firm in 2016.
We acknowledge your response date March 4, 2019, in which you state that you currently practice a comprehensive process in receiving, holding and distributing, and that you will work with your contract manufacturer in the scope of your MOU to create a written policy regarding these issues that will mirror the best practices from their Standard Operating Procedures. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that in a communication to FDA dated May 23, 2016, you stated that you were going to contract with your outside IT consultant to develop a system for tracking lot number with customer orders and develop written standard operating procedures for holding and distributing operations, but we saw no evidence of such corrective actions during the February 2019 inspection.
8. Your firm failed to establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21 CFR 111.16. Specifically, you told the investigator that you did not have any written procedures for cleaning the physical plant or for pest control. Once you have established these procedures, you must make and keep records required for cleaning the physical plant and for pest control, as required by 21 CFR 111.23.
This is a repeat violation from the previous inspection of your firm in 2016.
We acknowledge your response date March 4, 2019, in which you state that you have maintained a long‐standing relationship with your pest control company that includes bi‐weekly inspections and service, that you will codify this relationship with Standard Operating Procedures that reflect your current practice, and that you will also consult with your contract manufacturer through your MOU to ensure compliance with any issues you may not be currently addressing. Your response indicates that you are in the process of creating and executing a Memorandum of Understanding (MOU) with your contract manufacturer and anticipate completing your SOPs for cleaning the physical plant and pest control in no less than 90 days. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that in a communication to FDA dated May 23, 2016, you stated that you had ongoing cleaning and pest control services, and that you were going to establish written standard operating procedures to codify the existing services that you currently implement, but we saw no evidence of such corrective actions during the February 2019 inspection.
9. Your firm failed to establish and follow written procedures for fulfilling the requirements for personnel, as required by 21 CFR 111.8. Specifically, you told the investigator that you did not have any written procedures for personnel procedures or qualifications. Once you have established these procedures, you must make and keep records required for fulfilling the requirements for personnel, as required by 21 CFR 111.14.
This is a repeat violation from the previous inspection of your firm in 2016.
We acknowledge your response dated March 4, 2019, in which you state that your current practices include specific procedures for personnel regarding cleanliness, hygiene and strict observance of mandatory "stay at home" requirements for illnesses, and that you will include these in your joint Standard Operating Procedures with your contract manufacturer and also include your current employee handbook that includes employee qualification requirements. Your recent response indicates that you are in the process of creating and executing a Memorandum of Understanding (MOU) with your contract manufacturer and anticipate completing your personnel SOPs. We cannot assess the adequacy of your proposed corrections at this time because you have not provided any documentation demonstrating those corrections. We also note that in a correspondence to FDA dated May 23, 2016, you stated that you had trained your staff on preventing microbial contamination and hygienic practices, and that you were going to develop written standard operation procedures to codify your existing practices, but we saw no evidence of such corrective actions during the February 2019 inspection.
Dietary Supplement Misbranding
Several of the dietary supplements you distribute are misbranded under section 403 of the Act [21 U.S.C. § 343], as described below. Additionally, even if your Cardio Advantage Plus were not an unapproved new drug and misbranded drug, it would be misbranded as a dietary supplement under section 403 of the Act, as described below:
10. Your Energy Food for Joints product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, shellfish, as required by section 403(w)(1) of the Act. Specifically, your product is labeled with the statement “Warning: This product contains shellfish” on the panel to the right of the information panel. Further, the common or usual name of the shellfish is required to be listed.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
11. Your Agua Vitae “Water of Life,” Brain Booster, Energy Food for Joints, Prosta-Plex Plus, Agua Vitae Men, Dense Bone, Agua Vitae Women, Diatrol Plus, Cardio Advantage Plus, 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 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) Table 2. Specifically:
a. Your Agua Vitae “Water of Life” supplement facts label shows a serving size of 1 ounce. Your “Suggested Use” says to take 1-3 ounces per day with meals. As such, your serving size should be 3 ounces.
b. Your Brain Booster supplement facts label shows a serving size of 4 capsules. Your “Suggested Use” says to “Take 4 capsules daily. For best results, take 2 capsules in the morning with breakfast and 2 in the evening with dinner.” As such, your serving size should be 2 capsules.
c. Your Energy Food for Joints supplement facts label shows a serving size of 6 capsules. Your “Suggested Use” says to “6 capsules daily. For best results, take 3 capsules with your morning meal and 3 capsules with your evening meal.” As such, your serving size should be 3 capsules.
d. Your Prosta-Plex Plus supplement facts label shows a serving size of 6 capsules. Your “Suggested Use” says to “For best results, take 3 capsules twice daily.” As such, your serving size should be 3 capsules.
e. Your Agua Vitae Men supplement facts label shows a serving size of 8 capsules. Your “Suggested Use” says to “For best results, take 4 capsules with your morning & evening meals.” As such, your serving size should be 4 capsules.
f. Your Dense Bone supplement facts label shows a serving size of 4 capsules. Your “Suggested Use” says to “For best results, take 2 capsules in the morning and 2 in the evening.” As such, your serving size should be 2 capsules.
g. Your Agua Vitae Women supplement facts label shows a serving size of 8 capsules. Your “Suggested Use” says to “For best results, take 4 capsules with your morning & evening meals.” As such, your serving size should be 4 capsules.
h. Your Diatrol Plus supplement facts label shows a serving size of 4 capsules. Your “Suggested Use” says to “Take 4 capsules daily. For best results, take 2 capsules with your morning and evening meals.” As such, your serving size should be 2 capsules.
i. Your Cardio Advantage Plus supplement facts label shows a serving size of 4 capsules. Your “Suggested Use” says to “Take 4 capsules daily. For best results, take 2 with your morning and evening meals.” As such, your serving size should be 2 capsules.
j. Your Menopause supplement facts label shows a serving size of 4 capsules. Your “Suggested Use” says to “Take 4 capsules daily. For best results, take 2 with breakfast and 2 with dinner.” As such, your serving size should be 2 capsules.
12. Your Agua Vitae “Water of Life” product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. §343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, your product contains chemical preservatives, sodium benzoate and potassium sorbate; however, it fails to bear labeling stating that fact in accordance with 21 CFR 101.22(j).
13. Your Cardio Advantage Plus, Agua Vitae “Water of Life”, Menopause, Diatrol Plus, Agua Vitae Men, Dense Bone, Brain Booster, Energy Food for Joints, Prosta-Plex Plus, and Agua Vitae Women products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example
a. Your Agua Vitae “Water of Life” supplement facts label lists two ingredients, “Mineral Complex” and “Citrus Bioflavonoids,” which are themselves comprised of multiple ingredients but you do not list those sub-ingredients.
b. Your Agua Vitae Men supplement facts label lists ingredients, “Male Essentials Complex,” “Trace Mineral Complex,” “Energy Complex,” “Fruit & Vegetable Complex,” and “Antioxidant Complex,” which are themselves comprised of multiple ingredients but you do not list those sub-ingredients.
c. Your Agua Vitae Women supplement facts label lists ingredients, “Female Essentials Complex,” “Trace Mineral Complex,” “Energy Complex,” “Fruit & Vegetable Complex,” and “Antioxidant Complex,” which are themselves comprised of multiple ingredients but you do not list those sub-ingredients.
d. Your Cardio Advantage Plus, Menopause, Diatrol Plus, Agua Vitae Men, Dense Bone, Brain Booster, Energy Food for Joints, Prosta-Plex Plus, and Agua Vitae Women products declare in the ingredient statement “vegetable capsule(s)” but fail to list the ingredients that make up the capsule.
e. Your Agua Vitae “Water of Life” product label does not declare the common or usual name of polysaccharide fiber or chuchuhuasi.
f. Your Diatrol Plus product does not declare the standardized common name for Gymnema sylvestre as noted in Herbs of Commerce.
g. Your Menopause and Brain Booster product labels list in the Supplement Facts the names DHEA and DMAE bitartrate, respectively. These names need to be spelled out.
14. Your Agua Vitae “Water of Life,” Brain Booster, Prosta-Plex Plus, Diatrol Plus, and Menopause products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail 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). For example:
a. The Agua Vitae “Water of Life”label does not identify the part of the plant for the Aloe Very, Noni, Elderberry, Cranberry, Pomegranate, Aronia, Maqui, Acai, Mangosteen, Goji, Tumeric (sic), Milk Thistle, Green Tea, or Myrrh.
b. The Brain Booster does not list the part of the plant for the Bacopa, Gingko, and Green Tea.
c. The Prosta-Plex Plus does not list the part of the plant for the Saw Palmetto.
d. The Diatrol Plus does not list the part of the plant for the Garcinia Cambogia.
e. The Menopause product label lists “aerial part” which is not a specific part of the plant for the alfalfa in the “Proprietary MenoRelief Complex.”
15. Your Agua Vitae “Water of Life,” Agua Vitae Women and Prosta-Plex Plus 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 of your products do not comply with 21 CFR 101.36. For example,
a. Your Agua Vitae “Water of Life” product label contains nutrients in quantitative amounts which may be declared as zero. Any (b)(2)-dietary ingredients not present, or in amounts that can be declared as zero in 21 CFR 101.9(c), must not be declared [21 CFR 101.36(b)(2)].
b. Your Prosta-Plex Plus product lists beta carotene but fails to list the amount of Vitamin A. Similarly, your Agua Vitae Women product lists Vitamin A and elsewhere in the Supplement Facts lists beta carotene. Beta-Carotene may be declared as the percent of vitamin A that is present as beta-carotene, except that the declaration is required when a claim in made about beta-carotene. [21 CFR 101.36(b)(i)(B)(3)]
c. Your Prosta-Plex Plus product label lists Vitamin C, “Vitamin D-3”, and zinc but fails to declare the source of each dietary ingredient as required by 21 CFR 101.36(d). We also note Vitamin D should be listed as the dietary ingredient; if the source ingredient for Vitamin D is listed in the Supplement Facts, then it must be listed by its common or usual name and placed in parentheses immediately following or indented beneath the name of the dietary ingredient. [21 CFR 101.36(d)]
d. The following products declare an incorrect %DV based upon the quantitative amount of the listed dietary ingredient in the Supplement Facts label:
i. Agua Vitae Men and Agua Vitae Women product labels--potassium
ii. Dense Bone—Vitamin D and Vitamin K
e. Your Agua Vitae “Water of Life” product label incorrectly declares the quantitative amount of sodium with “**” (Percent Daily Value Not Established) and fails to correctly place the dietary ingredient before potassium. [21 CFR 101.9(c)(4) and (9), 21 CFR 101.36(b)(2)(i)(B), and 21 CFR 101.36(b)(2)(iii)(C)]
16. Your Agua Vitae Men and Agua Vitae Women products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is misleading because it fails to state a material fact [see section 201(n) of the Act (21 U.S.C. § 321(n))]. Specifically, the labels of these products fail to bear the following warning statement about the risk of fatal poisoning in children under 6:
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Dietary supplements in solid oral dosage form that contain iron or iron salts are required to bear this warning statement [see 21 CFR 101.17(e)]. The labels on your Agua Vitae Men and Agua Vitae Women products, which are in capsule form, declare iron as an ingredient. However, the labels do not include the warning statement required by 21 CFR 101.17(e).
17. Your Agua Vitae “Water of Life” 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 an ingredient identified as Siberian Ginseng. That ingredient 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 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, including FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen 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 cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
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 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. 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 reinspection-related to costs from the responsible party for the domestic facility.
Please send your written response to the attention of:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case#576771
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-2922 ext 103.
Sincerely,
/S/
Darla R. Bracy, District Director
Office of Human and Animal Foods
Division West 5
cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capital Avenue – MS7602
P. O. Box 997413
Sacramento, California 95899-7435
Content current as of:
08/20/2019
Regulated Product(s)
Drugs