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").
Unapproved New Drugs
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:
INF-D
* "Designed to support inflammatory syndrome of a chronic nature."
(b)(4)
* "
(b)(4) inflammatory
(b)(4)."
Examples of some of the claims on your website, www.professionalbotanicals.com, that provide evidence that your products are intended for use as drugs include:
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)
Pressu-Norm
* "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.
Adulterated Dietary Supplements
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.
The significant violations documented during the inspection include, but are not limited to, the following:
1. You failed to establish product specifications for the identity, purity, strength and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). During the inspection it was determined that you create the product formulations for your dietary supplement products and provide product specifications to your contract manufacturer. However, your specifications for identity and purity are inadequate for determining the identity and purity of the finished batch of your dietary supplement products. Specifically, the specifications established for identity failed to provide a full description of the reference standard to be used. Additionally, the specification for composition failed to identify the analyte(s) of interest and how you would accurately measure the analyte(s) in the presence of other components. Also, it appears there are no specifications established for purity and strength.
2. You failed to identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision, as required by 21 CFR 111.510.
During the inspection, you stated that returned dietary supplements are not quarantined upon receipt; and we observed that returned dietary supplements were not identified and quarantined until a disposition decision was made. Moreover, you were not able to provide documentation of a material review and disposition decision for returned products that you destroyed. Under 21 CFR 111.535(b)(2), you must make and keep records of any material review and disposition decision on a returned dietary supplement.
In your November 06, 2016 response, you stated that you added a returned product bin to your quarantine section, trained personnel that products are not to be released until after review by quality control personnel, and trained quality control personnel on your procedure to review all product returns. However, you did not provide documentation of your revised written procedures reflecting that returned dietary supplements will be identified and quarantined until quality control personnel conduct a material review and make a disposition decision.
3. You did not establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. During the inspection, you stated that you did not have a written procedure for holding and distribution operations. You were made aware of this deficiency previously during our inspection conducted in February 2013.
We have reviewed your response dated November 06, 2016. However, your response only provides specifications relating to temperature control and does not provide written procedures for operations such as control of storage location and conditions that will protect the dietary supplement under distribution from contamination or deterioration.
Misbranded Products
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.
2. Your
Professional Botanicals brand Viral-Aid, Professional Botanicals brand Immu-Guard, Professional Botanicals brand INF-D, (b)(4), and Professional Botanicals brand Pressu-Norm products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because each 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).
For example, the label for Viralaid fails to declare the part of the plant from which the Panax Ginseng is derived.
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.
4. Your Professional Botanicals brand Immu-Guard, Professional Botanicals brand Viral-Aid, Professional Botanicals brand INF-D, Professional Botanicals brand Pressu-Norm, and
(b)(4) products are misbranded within the meaning of section 403(s)(2)(A)(ii)(II) of the Act [21 U.S.C. § 343 (s)(2)(A)(ii)(II)] in that the labels fail to include the total quantitative amount by weight per serving size of all other dietary ingredients contained in the proprietary blend as required by 21 CFR 101.36(c)(3).
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).
6. Your Professional Botanicals brand Viral-Aid, Professional Botanicals brand INF-D, Professional Botanicals brand Pressu-Norm, and
(b)(4) products are misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act [21 U.S.C. § 343(s)(2)(A)(ii)(I)] in that the labels fail to include the quantitative amount by weight per serving size of all other dietary ingredients as required by 21 CFR 101.36(b)(3).
7. Your Professional Botanicals brand Viral-Aid, Professional Botanicals brand Immu-Guard,
(b)(4), Professional Botanicals brand Pressu-Norm, and Professional Botanicals brand INF-D 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 labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(a), (g), and (h). For example:
a. For your Professional Botanicals brand Viral-Aid product we note the genus name Paeonia is listed with no species and for your Professional Botanicals brand Viral-Aid and Professional Botanicals brand Immu-Guard products we note the genus names Ganoderma and Artemisia are listed with no species. The genus name along with the species must be spelled out initially. If the same genus is being listed with a different species, then the genus may be abbreviated with the first letter of the genus being capitalized and followed by a period. Furthermore, for your Professional Botanicals brand Immu-Guard, the source of the thymus should be declared.
b. Your Professional Botanicals brand Viral-Aid product declares Scute and your Professional Botanicals brand Immu-Guard product declares Ji Xue Teng and Scute. However, these are not the common or usual names, and specifically, for a botanical, not the standardized common name noted in the reference, Herbs of Commerce.
c. Your Professional Botanicals brand Viral Aid and Professional Botanicals brand Immu-Guard products fail to declare the ingredients used to form the capsule.
8. Your Professional Botanicals brand Viral-Aid, Professional Botanicals brand INF-D, Professional Botanicals brand Immu-Guard, Professional Botanicals brand Pressu-Norm, and
(b)(4) 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 product does not comply with 21 CFR 101.36. For example:
a. Your
(b)(4) product label lists a % Daily Value for vitamin B-12, vitamin E, zinc, and selenium which is in the incorrect increment. The percentages based on RDI's must be expressed to the nearest whole percent in accordance with 101.36(b)(2)(iii)(C).
b. Your
(b)(4) product label lists vitamin A, vitamin C, vitamin E, and vitamin B12 in the wrong order. The vitamins must be presented in accordance with 21 CFR 101.36(b)(2)(i)(B) and 101.9(c).
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)]
d. Your Professional Botanicals brand INF-D product label declares a %DV for vitamin C and calcium that is not correct based on the amount per serving declared.
e. Your Professional Botanicals brand Immu-Guard product declares vitamin B3, vitamin B5, and vitamin B9 which is not the nomenclature or synonym specified for niacin, folate, and pantothenic acid in 21 CFR 101.9 or 101.36(b)(2)(i)(B).
f. Your Professional Botanicals brand Immu-Guard product label declares biotin with an amount of 1% DV and calcium with 0% DV. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
9. Your Professional Botanicals brand Viral-Aid, Professional Botanicals brand INF-D, Professional Botanicals brand Pressu-Norm, and
(b)(4) products are misbranded within the meaning of sections 403(q)(1)(B) 21 U.S.C. §343(q)(1)B] and 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the labels fail to list the number of servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii).
10. Your Professional Botanicals brand Viral-Aid, Professional Botanicals brand INF-D, Professional Botanicals brand Immu-Guard, and Professional Botanicals brand Pressu-Norm products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
11. 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(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, milk, as required by section 403(w)(1) of the Act. Specifically, your Veo Natural brand Pearl 3.0 Ultimate Meal Drink and Professional Botanicals brand Mealplex Ultimate Meal Drink product is manufactured using whey protein concentrate that is derived from milk.
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)].
12. 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically:
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)).
13. 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(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information does not meet the requirement as defined in 21 CFR 101.9. Specifically:
a. Trans Fat is not listed as required by 21 CFR 101.9(c)(2)(ii).
b. There is no provision for the inclusion of "Net Carbohydrates" within a Nutrition Facts label [21 CFR 101.9(c)]
c. The statement of the amount per serving for calories, Total Fat, Saturated Fat, Cholesterol, Sodium, and Potassium are not listed in the correct increments [21 CFR 101.9(c)(1), (c)(2), (c)(2)(i), (c)(3), (c)(4) and (c)(5), respectively]
d. % Daily Value declaration for all vitamins and minerals, except Vitamin A and Copper, are not in accordance with 21 CFR 101.9(c)(8)(iii).
e. In general, the Nutrition Facts label does not bear hairlines and bolding as required by 21 CFR 101.9(d).
14. 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(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example,
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."
c. Naturally occurring constituents of an ingredient, such as the list of amino acids following pea protein isolate, are not considered ingredients and are not permitted in the ingredient list under 21 CFR 101.4.
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.
15. 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(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). The Veo Natural Pearl 3.0 label also fails to include the name of the business as required in 21 CFR 101.5(a).
16. 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(e) of the Act [21 U.S.C. § 343(e)] and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA)
[15 U.S.C. §1453(a)(3)] for failing to declare the net quantity of contents in terms of avoirdupois pound and ounce (21 CFR 101.7(b)(1)). In addition, under 21 CFR 101.7(j)(3), the term "net weight" shall be used when stating the net quantity of contents in terms of weight.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. It is your responsibility to ensure that your firm complies with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
We also offer the following comments regarding the labeling of your products:
- Your Professional Botanicals brand Viral-Aid, Professional Botanicals brand INF-D, Professional Botanicals brand Pressu-Norm, and (b)(4) products bear Other Ingredients within the Supplement Facts label. We note that the ingredient list should be separate from the Supplement Facts. Furthermore, we refer you to 21 CFR 101.36(e) regarding the formatting of the Supplement Facts labels, specifically with respect to the use of heavy bar, light bars, and hairline rules.
- The labels do not bear the exact text for the FDA disclaimer statement in accordance with 21 CFR 101.93(c).
- 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 for vitamins and minerals is not separated from information on other nutrients by a bar in accordance with 21 CFR 101.9(d)(8).
- The use of colons after the headings Serving Size, Calories and Calories from Fat is not permitted.
- The nutrition information fails to include "Servings Per Container" as required by 21 CFR 101.9(d)(3).
- The headings, nutrient names, and percentages are not bolded as required by 21 CFR 101.9(d)(1)(iv).
- You appear to be using the 1993 nutrition labeling format. This format does not permit the declaration of quantitative amounts of vitamins and minerals in the nutrition label.
- 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)).
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation that would assist us in evaluating your corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining violations.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related to 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 re-inspection related costs.
