WARNING LETTER
Vital Hierbas Naturales Corporation
MARCS-CMS 540077 —
March 30, 2018
Recipient:
Recipient Name
Maria Carlin Rangel
Vital Hierbas Naturales Corporation
2100 W 24th St
Chicago
,
IL
60608
United States
Issuing Office:
Chicago District Office
United States
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187
Warning Letter
FY18-HAFE6-04
March 30, 2018
UPS NEXT DAY
SIGNATURE REQUIRED
Maria Carlin Rangel, President
Vital Heirbas Naturales Corporation
2100 W 24th St
Chicago, IL 60608
Dear Ms. Rangel,
This is to advise you that the Food and Drug Administration (FDA) reviewed your product labels for Vital Clean Parasit, Vital Depresion Tea, VitalAshma Tea, VitalRelief Tea, VitalDiurec Tea, Vital Arthri Tea, Nopalinasa Vital Flax Seed Plus Vital, and VitalDiabe Tea following an inspection of your facility at 2100 W 24th St, Chicago, IL 60608 between August 22, 2017 and September 12, 2017. The claims on your product labels establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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, we have determined that your VitalWoman Tea, VitalRelax Tea, and VitalLaxan Tea products are misbranded under section 403 of the Act [21 U.S.C. 343] and its implementing regulations under 21 CFR part 101, and that, even if your Vital Clean Parasit and Nopalinasa Vital Flax Seed Plus Vital products were not drugs under section 201(g)(1)(B) of the Act, they would be misbranded under section 403 of the Act [21 U.S.C. 343] and its implementing regulations under 21 CFR part 101.
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 FDA’s home page at
www.fda.gov
.
Examples of some of the claims on your product labels that provide evidence that your products are intended for use as drugs include:
Vital Clean Parasit
• “Basil: Helps to relieve stomachache… and to eliminate parasits”
• “Aloe Vera: … [c]ontributes to overcome squares of ulcers and indigestion.”
• “Garlic: … protects against infection, Helps to expel parasites.”
• “Walnut Shell: Helps the scaring of ulcers.”
• Pasaya Seed: Helps … indigestion and intestinal inflammation. Contributes to elimination of parasites”
• “Pumpkin Seeds: … [h]elps eliminate intestinal worms and disorders.”
• “Bentonite: Helps to remove parasites and toxins of the colon walls.”
• “Epasete: Helps to cure stomachaches and indigestion. Antiparasite.”
• “Parsley: … antiparasite.”
• “Fiber: Reduces constipation, expels toxins in the colon and helps to prevent colon cancer.”
VitalDepresion Tea
• The product name.
VitalAshma Tea
• “…Evita la asfixia”
• English Translation: Avoids suffocation.
VitalRelief Tea
• “Ayuda a reducer las flemas, gripa, resfriados, decaimiento, escalofrios, fiebre y tos”
• English Translation: Helps to reduce phlegm, flu, colds, fatigue, chills, fever and cough.
VitalDiurec Tea
• “Evita sistitis, inflamaciones, mal de orin.”
• English Translation: Avoids cystitis, inflammations, difficulty urinating.
VitalArthri Tea
• “Ayuda a combatir artritis y reumas. Limpia a la sangre, nivela el acido urico”
• English Translation: Helps fight arthritis and rheumatism. Cleans the blood, levels out uric acid.
Nopalinasa Vital Flax Seed Plus Vital
• “Flax seed: Helps treat and prevent cancer. Prevents colon cancer, gastritis and colitis.”
• “Prickly Pear Cactus: Extremely beneficial for lowering blood sugar levels.”
• “Apple: … [h]elps . . , fight cellulitis.”
• “Celery: … [h]elps to combat cellulitis.”
VitalDiabe Tea
• “Ayuda a regular la insulin, neutraliza el azucar, Evita mareos, debilidad y sed.”
• English Translation: Helps regulate insulin, neutralizes sugar, prevents dizziness, weakness, and thirst.
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 products Vital Clean Parasit, VitalDepresion, and Nopalinasa Vital Flax Seed Plus Vital 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, Vital Clean Parasit, VitalDepresion, and Nopalinasa Vital Flax Seed Plus Vital 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)].
Misbranded Food
Your Vital Woman Tea, VitalRelax Tea, and VitalLaxan Tea products are misbranded under section 403 of the Act [21 U.S.C. 343] in that their labels do not comply with the labeling requirements in 21 CFR part 101. Additionally, even if the labels of your Vital Clean Parasit and Nopalinasa Vital Flax Seed Plus Vital products did not contain claims that cause these products to be unapproved new drugs, these products would still be misbranded foods under section 403 of the Act [21 U.S.C. 343] in that their labels do not comply with the labeling requirements in 21 CFR part 101, for the reasons described below.
Your Vital Clean Parasit and Nopalinasa Vital Flax Seed Plus Vital products are misbranded under section 403(q)(1)(c) of the Act [21 U.S.C. § 343(q)]. Specifically,
• Trans fat is not declared (21 CFR 101.9(c)(2)(i)).
• Sugars is not declared (21 CFR 101.9(c)(6)(ii).
• Potassium is declared but with no value listed.
• “4.8Q” is not an appropriate caloric content declaration (21 CFR 101.9(c)(1).
• Vitamins and minerals are not declared (21 CFR 101.9(c)(8)).
• The nutrition label for the Nopalinasa Vital Flax Seed Plus Vital product fails to declare vitamin C when a nutrient content claim is made on the label (i.e. “Pineapple: Excellent source of vitamin C.” (21 CFR 101.9(c)(8).
Your Clean Parasit, VitalWoman Tea, VitalRelax Tea, VitalLaxan Tea products are misbranded under section 403(i)(2) of the act [21 U.S.C. § 343(i)(2)] because the ingredients are not by their common or usual name in English and some of the English ingredient statements do not match the Spanish ingredient statements. Specifically:
• For your Clean Parasit product fiber is not an appropriate common or usual name for an ingredient. Additionally, 11 ingredients are listed in English while only 10 ingredients are listed in the foreign language.
• For your VitalWoman Tea product, uva ursi and borraja, are not declared by their common or usual names.
• For the VitalRelax Tea product, all the ingredients, azahar mano, tila trompo, tila esuella, toronjil, tumvaquero, muerdago, and brasil damiana are not declared by their common or usual name.
• For the VitalLaxan Tea, the ingredient boldus is not declared by its common or usual name.
The agency has received your response letter, dated September 20, 2017, to the violations discovered during our inspection. The response letter did not address any corrections to the labels of your products.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all your products and labeling are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, but not limited to, seizure and/or injunction.
Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should explain the specific steps you have taken to correct the violations noted above. Your response should include any documentation necessary to show that the violations have been corrected. If you cannot complete all corrections within fifteen working days, please explain the reason for the delay and state the date by which you will correct any remaining violations.
Your written response should be sent to Lauren Crivellone, Compliance Officer, FDA Chicago District Office, U.S. Food and Drug Administration, 550 W. Jackson Blvd., Suite 1500, Chicago, IL 60661.
If you have any questions about the content of this letter, please contact Ms. Crivellone via email at
lauren.crivellone@fda.hhs.gov
or by phone at (312)-596-4157.
Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Division of Human and Animal Food
Operations Division 6 East
Content current as of:
04/10/2018