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Supplement Safety Checker
Notice: Official Public Record

Professional Botanicals, Inc. FDA Warning (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 06, 2017

MODERATE SEVERITY Denver District Office 2017
Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to Professional Botanicals, Inc. on July 06, 2017 citing labeling violations. The letter was issued by Denver District Office.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

The labels do not bear the exact text for the FDA disclaimer statement in accordance with 21 CFR 101.93(c).

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)).

Potential Health Risks

Consumers should be aware of potential risks associated with products from Professional Botanicals, Inc..

Regulatory Context

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)].

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.

Key Entities Identified

21 CFR 101.36 21 CFR 101.93 21 CFR 101.4 section 403(w) section 403(w)

Frequently Asked Questions

What did the FDA find wrong with Professional Botanicals, Inc.?
The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
Are Professional Botanicals, Inc. products safe to use?
Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
What should I do if I've used Professional Botanicals, Inc. products?
If you have used products from Professional Botanicals, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter
Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.