Source: https://www.casewatch.net/fdawarning/prod/2017/professional.shtml
Timestamp: 2020-02-17 16:26:01
Document Index: 534104789

Matched Legal Cases: ['§ 321', '§ 321', '§ 355', '§ 331', 'art 111', 'art 111', '§ 342', '§ 343', 'art 101', '§ 343', '§ 343', '§343', '§ 343']

FDA Warning Letter to Professional Botanicals, Inc. 7/6/17
Allan C. Millet, Owner
Professional Botanicals, Inc.
1069 Stewart Drive
Ogden, UT 84404-1351
Ref: # HAF4W(DEN)-17-11-WL
Dear Mr. Millet:
On October 04-11, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 1069 Stewart Drive, Ogden, UT. In addition, FDA reviewed your websites at the internet addresses www.professionalbotanicals.com and www.veonatural.com, and has determined that you take orders there for your products. Based on the inspection, a review of the product labels collected during the inspection, and a review of your websites, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA 483 detailing our investigator’s observations during the inspection. We received your letter dated November 06, 2016, containing responses to those observations. Because the observations on the Form FDA 483 and your responses relate to compliance with the cGMP regulations for dietary supplements, we discuss our assessment of your responses in the cGMP section of this letter (entitled “Adulterated Dietary Supplements”).
Based on our recent review of your product labels and your website, www.professionalbotanicals.com, we have determined that the claims on your product labels and website establish that several of your firm’s products are drugs within the meaning of section 201(g)(1)(B) and/or (g)(1)(C) of the Act [21 USC § 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles (other than food) intended to affect the structure or any function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
We acknowledge your removal of the “search banner” from your website that allowed customers to search based on disease, as well as the product detail sheets. Examples of some of the claims on your product labeling that provide evidence that your products are intended for use as drugs include:
• “Designed to support inflammatory syndrome of a chronic nature.”
• “(b)(4) inflammatory (b)(4).”
Kidney Support – Cleanse & Support
• “[H]elping to break down kidney and gallstones...” (under Description)
• “I used to get kidney stones every 3 months, [sic] since we found Professional Botanicals and this wonderful product! I have only had one or two attacks in the last 5 years…” (under Customer Reviews)
Cranberry Complex – Urinary Immune Support
• “In addition to helping with urinary problems, cranberry may also help avoid gastrointestinal ulcers...”
Candida-X2 – Yeast Support
• “Fungal and yeast overgrowth cause those uncomfortable, itchy infection [sic]….approximately one billion people suffer from a fungal, mold or candida infection every year…”
• “…and then this powerful anti-fungal herb fights additional candida growth…”
• “I don’t often have yeast infections, but…..I’ve tried other products for this condition over the years but THIS STUFF REALLY DID the job…” (under Customer Reviews)
Lungs Mucus – Lung Support
• “Lungs Mucus is designed to support the body and lungs in times of congestion, mucus, or inflammation…”
Thyroid 3 – Hypo-Thyroid Support
• “Dr. Millet sent me to get blood work but put me on Thyroid 3 in the until [sic] I could get tests done. WOW [sic] What a difference it made…the last thing I wanted was to take a prescription thyroid medication…I started taking Ultimate Thyroid 3, I felt an immediate improvement,and [sic] I did not had [sic] to get a prescription…” (under Customer Reviews)
• “This powerful formula… and a return to normal blood pressure…”
Attack – Immune Support
• “A synergistic formula….build natural immunities to fight bacterial, microbiological, and inflammatory illnesses…”
AN-I Oil – Bacterial Support
• “An all-in-one anti-infection oil, AN-I Oil is designed for all types of injuries to support in the combat against infections and promote healing. It is especially good for open wounds...”
INF-D – Inflammatory Support
• “Designed to support the health of the immune system with regards to chronic inflammation. Give your immune system…to support the thinning and slowing of blood flow and the reduction of blood clot formation…”
Silver – Anti-Bacterial Support
• “…[R]egeneration of damaged cells and tissues, and helps prevent colds, the flu and organism caused diseases. It has also been used as a healing agent topically for rashes and skin irritations...”
• “My 5 year old contracted pink eye from one of the kids at daycare. I used a mixture of part water and part silver and used eyedropper to put it in his eye. The pink eye…was completely gone within 18 hours...” (under Customer Reviews)
WP Detox – Parasite Support
• “Supports the removal of worms and parasites from the intestinal tract and in the removal of liver and gallbladder flukes.”
Cell Detox – Cellular Detox Support
• “… I had a rash that itched so badly it was driving me crazy. I discovered it was caused by candida. I started a candida program but was surprised when I was told the rash was a result of the the [sic] candida moving into the blood. …suggested I start a blood cleanse using Cell Detox. … After the 10 days of using Cell detox, I was amazed. …my rash cleared up ... I didn't realize I even had a candida infection… also great for fungal, Molds [sic] and metals too.” (under Customer Reviews)
Your above-listed 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)(1) of the Act [21 USC § 321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 USC § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331 (d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
Even if your product labels and websites did not contain claims that render the products unapproved new drugs, our investigator observed the following violations of FDA’s Current Good Manufacturing Practice (cGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which would render your products adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below.
Additionally, several of your products are misbranded under section 403 of the Act [21 U.S.C. § 343] and FDA’s labeling regulations under 21 CFR Part 101. Our review of your product labels and websites revealed the following violations:
1. Your Veo Natural brand Pearl 3.0 Ultimate Meal Drink and Professional Botanicals brand Mealplex Ultimate Meal Drink products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that their labeling is false or misleading. The labeling of each product identifies the product as a “dietary supplement” while also describing it as a “meal drink” and a “meal replacement.” Under section 201(ff)(2)(B) of the Act [21 U.S.C. 321(ff)(2)(B)], the term “dietary supplement” means a product that, among other requirements, “is not represented for use as a conventional food or as a sole item of a meal or the diet.” Therefore, your products cannot be both dietary supplements and conventional foods or sole items of a meal. Because you represent them as both, their labeling is false or misleading.
3. Your Professional Botanicals brand Immu-Guard and (b)(4) products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number.
5. Your Professional Botanicals brand Immu-Guard product is misbranded within the meaning of section 403(s)(2)(A) of the FD&C Act [21 U.S.C. §343(s)(2)(A)] in that the label declares EDS® (a blend of enzymes and co-factors) and AdPT®, but fails to list the name of each ingredient of the proprietary blends that is described in section 201(ff) and identified by the term “Proprietary Blend” or other appropriately descriptive term or fanciful name in accordance with 21 CFR 101.36(c). Further, your label fails to list the other dietary ingredients in descending order of predominance by weight in accordance with 21 CFR 101.36(c)(2). Further, your label fails to list the total weight of all other dietary ingredients contained in these proprietary blends in the Supplement Facts panel in accordance with 21 CFR 101.36(c)(3).
c. Your Professional Botanicals brand Viral-Aid, Professional Botanicals brand INF-D, Professional Botanicals brand Immu-Guard, Professional Botanicals brand Pressu-Norm, and (b)(4) product label’s proprietary blend fails to bear a symbol (e.g., an asterisk) in the column under the heading of %DV that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement “% Daily Value not established.” [21 CFR 101.36(b)(3)(iv)]
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
a. Your Veo Natural brand Pearl 3.0 Ultimate Meal Drink and Professional Botanicals brand Mealplex Ultimate Meal Drink product labels bear the claim, “LOADED WITH AMINO ACIDS…” The term “loaded with” can be considered a synonym for "high" or "good source”. Although your products use this term in their claims, they do not comply with the requirements in 21 CFR 101.54(b) for "High" claims or 21 CFR 101.54(c) for "Good Source" claims, which are nutrient content claims authorized by regulation, because there is no established Reference Daily Intake (RDI) or Daily Reference Value (DRV) for amino acids. Further, in accordance with 21 CFR 101.13(b), for a claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under 21 CFR 101.9 or under 21 CFR 101.36 (that is, a nutrient content claim), the nutrient must be included in the Nutrition Facts label. Your Nutrition Facts label does not list any amino acid. Further, as a meal replacement product subject to 21 CFR 101.9, amino acids may not be listed as they are not provided for in this regulation.
b. Your Professional Botanicals brand Mealplex Ultimate Meal Drink product is sold on your website, professionalbotanicals.com, with the claim of “no sugar added”. As set forth in 21 CFR 101.60(c)(2)(v), the term “no sugar added” may be used in the labeling of a product that does not meet the requirements for a “low” or “reduced calorie” food only if the product bears a statement that the food is not “low calorie” or “calorie reduced” and directs consumers’ attention to the nutrition panel for further information on sugar and calorie content. This product does not meet the requirements for a “low calorie” or “calorie reduced” food because it provides more than 40 calories per RACC (21 CFR 101.60(b)(2)(i)).
b. There is no provision for the inclusion of “Net Carbohydrates” within a Nutrition Facts label [21 CFR 101.9(c)]
a. “Fibersol 2,” “Pre-biotic Natural Fiber,” “AdPT” and “stevia leaf extract“ are not the common or usual names for these ingredients.
b. “EDS®” is not the common or usual name of the ingredients further noted to be “Amylase, Protease, Lipase, and Cellulase.”
d. “Contains” is not permitted by 21 CFR 101.4 within the ingredient list and is typically seen in accordance with section 403(w) of the Act. The “Contains” and “sweetener” phrases are intervening material per 21 CFR 101.2(e) and should be listed outside the nutrition information panel.
The term “Current”, as listed in the Supplement Facts label, is incorrectly spelled for your Professional Botanicals brand INF-D product.
For your (b)(4), Professional Botanicals brand Pressu-Norm, Professional Botanicals brand Viral Aid, and Professional Botanicals brand INF-D products, use of the term “Contains” is not provided for within the context of the dietary ingredient listing for dietary supplements, in accordance with 21 CFR 101.4 and 21 CFR 101.36; furthermore, it is considered intervening material.
We are unable to determine if your firm is using the full vertical format or tabular format. As specified in 21 CFR 101.9(j)(13)(ii), nutrition information may be provided in a tabular or linear (i.e., string) format rather than in vertical columns if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape or size cannot accommodate a standard vertical column or tabular display on any label panel. In addition, if there is not sufficient continuous vertical space (i.e. approximately 3 in.) to accommodate the required components of the nutrition label up to and including the mandatory declaration of iron, the nutrition label may be presented in a tabular display under 21 CFR 101.9(d)(11)(iii). If the standard vertical format is being used, we note that the heading “Nutrition Facts” does not span the full width of the information provided as required by 21 CFR 101.9(d)(2).
The nutrition information fails to include “Servings Per Container” as required by 21 CFR 101.9(d)(3).
Your Veo Natural brand Pearl 2.0 Ultimate Meal Drink product appears to be sold on your website, www.veonatural.com. We note that your website bears the nutrient content claim “LOW CALORIE”, but provides nutrition information specifying more than 40 calories per RACC (see 21 CFR 101.60(b)(2)(i)). Your website also bears the nutrient content claim, “PACKED WITH . . . ANTI-OXIDANTS,” but does not include the names of the nutrients that are the subject of the claim as part of the claim or link the term “ANTI-OXIDANTS” 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 (see 21 CFR 101.54(g)).
Your written response should be sent to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. If you have questions regarding any issues in this letter, please contact Ms. Schmidt at (303) 236-3046.