- Delivery Method:
- UPS Overnight
- Product:
- Drugs
Food & Beverages
- Recipient:
-
Recipient Name
Tommy W. Kerzee
- Lone Star Botanicals Inc.
2001 Broussard St.
Tyler, TX 75701-8406
United States
- Issuing Office:
- Division of Human and Animal Food Operations East III
United States
Secondary Issuing Offices
November 6, 2023
CMS 659735
WARNING LETTER
Dear Tommy Kerzee:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, located at 2001 Broussard St., Tyler TX 75701 on April 17-21, 2023. Your firm manufactures and repackages, among other food products, ready-to-eat (RTE) seasoning blends. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA- 483), Inspectional Observations, listing the deviations found at your firm. Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) seasoning products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the Preventive Controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your seasoning blends and Dr. Botanical Health products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343).
FDA also reviewed your product labels, product brochure, and website at the Internet address https://drbotanicalhealth.com/. The claims on your product labels, product brochure, and your website establish that certain of your products 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. 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.
On May 3, 2023, FDA received your written response to the Form FDA 483, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings, response that your firm provided, product labeling collected during the inspection, and your website, we are issuing this letter to notify you of FDA’s concerns and provide detailed information describing our findings. We also address your response below.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website at the Internet address https://drbotanicalhealth.com/ in July 2023 and October 2023, and has determined that you take orders there for your Dr. Botanicals Health products Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Cordyceps Mushroom Based Superfood Powder, Organic Acai Plant Based Superfood Powder, Organic Inulin Prebiotic Fiber Superfood Powder, Organic Chaga Mushroom Based Superfood Powder, Organic Maca Plant Based Superfood Powder, Organic Reishi Mushroom Based Superfood Powder, and Organic Rhodiola Rosea Plant Based Superfood Powder. In addition, FDA reviewed your product labels collected during the inspection for your Dr. Botanical Health products Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, and Organic Cordyceps Mushroom Based Superfood Powder, as well as your Dr. Botanical Health Product Brochure, which directs consumers to your website https://drbotanicalhealth.com/ to purchase your products. The claims on your website, product labels, and product brochure establish that the products 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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
- Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder
o “Anti-inflammatory”
o “It’s known to help reduce anxiety ….”
o “It…reduces anxiety and depression ….”
o “Ashwagandha powder can help reduce inflammation ….”
- Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder
o “Helps Fight Colds & the Flu”
o “It’s often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea ….”
o “It also has anti-inflammatory properties, which makes it useful for treating allergies and sinus infections … scientifically proven to be effective at treating colds and flu, particularly at the onset of a cold or flu.”
o “Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu … Not only can elderberry help prevent colds and flu, but it can also be used to treat allergies, including hay fever, and sinus infections. It’s thought to be particularly effective against allergies and sinus infections ….”
- Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder
o From the list of hyperlinked “Tags” on the product page:
“anxiety”
“depression”
o “Rich in medicinal properties, Lion’s Mane mushrooms are thought to guard against dementia, reduce mild depression and anxiety, and help speed up recovery from injuries to the nervous system. Our extract powder can also help to regulate diabetes ….”
o “The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties.”
o “Lion’s mane mushrooms have been used medicinally for…skin diseases…reduce inflammation…. They are also used to help treat skin conditions such as psoriasis and eczema, as well as mental health conditions such as depression and anxiety.”
- Dr. Botanical Health Marine Collagen
o “Stabilizes blood sugar”
o “Reduces inflammation”
o “This powerful supplement is proven to stabilize blood sugar…reduce inflammation….”
o “[I]t can…reduce inflammation….”
- Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder
o From the list of hyperlinked “Tags” on the product page:
“anti-inflammatory”
Examples of some of the claims on your product labels that provide evidence that your products are intended for use as drugs include:
- Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder
o “Contains Anti-Tumor Properties”
o “Anti-Inflammatory”
- Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder
o “Contains Ant-Inflammatory Properties”
o “Helps Fight Infections Like Cold & Flu”
o “Fights Harmful Bacteria”
- Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder
o “Helps Combats [sic] Depression, Anxiety & Stress”
o “Anti-Inflammatory”
- Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder
o “Anti-Inflammatory”
Examples of some of the claims on your Dr. Botanical Health Product Brochure that provide evidence that your products are intended for use as drugs include:
- Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder
o “Ashwagandha. ...reduces anxiety and depression ….”
- Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder
o “The phytochemicals found in elderberries are known to fight infection, particularly in the respiratory system. High in antioxidants, it lowers cholesterol ….”
- Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder
o “Medicinally, Lion’s Mane mushrooms are thought to protect from dementia, reducing mild depression and anxiety, and increase recovery from nervous system injuries.”
- Dr. Botanical Health Marine Collagen
o “Marine Collagen is a powerful supplement proven to…reduce inflammation….”
- Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder
o “The benefits of this adaptogen also extends to fighting inflammation.”
- Dr. Botanical Health Organic Acai Plant Based Superfood Powder
o “Acai also helps lower cholesterol levels ….”
- Dr. Botanical Health Organic Inulin Prebiotic Fiber Superfood Powder
o “It is known for aiding in…constipation, diarrhea, and diabetes!”
- Dr. Botanical Health Organic Chaga Mushroom Based Superfood Powder
o “The health benefits of these mushrooms…include…lowering cholesterol, blood sugar and blood pressure…and fight unhealthy inflammation.”
- Dr. Botanical Health Organic Maca Plant Based Superfood Powder
o “Maca may also help…lower blood pressure ….”
- Dr. Botanical Health Organic Reishi Mushroom Based Superfood Powder
o “[T]hese mushrooms lower cholesterol, reduce allergic reactions ….”
- Dr. Botanical Health Organic Rhodiola Rosea Plant Based Superfood Powder
o “[T]his herb has been traditionally used to reduce anxiety, depression ….”
Your Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Cordyceps Mushroom Based Superfood Powder, Organic Acai Plant Based Superfood Powder, Organic Inulin Prebiotic Fiber Superfood Powder, Organic Chaga Mushroom Based Superfood Powder, Organic Maca Plant Based Superfood Powder, Organic Reishi Mushroom Based Superfood Powder, and Organic Rhodiola Rosea Plant Based Superfood Powder 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)]. With certain exceptions not applicable here, 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 safely used at the direction, and under the supervision, of a licensed practitioner.
Your Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Acai Plant Based Superfood Powder, Organic Inulin Prebiotic Fiber Superfood Powder, Organic Chaga Mushroom Based Superfood Powder, Organic Maca Plant Based Superfood Powder, Organic Reishi Mushroom Based Superfood Powder, and Organic Rhodiola Rosea Plant Based Superfood Powder 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 Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Acai Plant Based Superfood Powder, Organic Inulin Prebiotic Fiber Superfood Powder, Organic Chaga Mushroom Based Superfood Powder, Organic Maca Plant Based Superfood Powder, Organic Reishi Mushroom Based Superfood Powder, and Organic Rhodiola Rosea Plant Based Superfood Powder 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)].
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:
1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).
However, you did not have a food safety plan with any of the required elements. For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140). You must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.160). Specifically:
a. You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your facility manufactures RTE seasoning products that contain allergens (such as milk) which are processed using the same utensils on the same production day as products that do not contain milk. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR § 117.135(c)(2)).
You do not have controls in place for allergen cross-contact or perform and document the review of labels for proper declaration of allergens. For example, you do not identify ingredients used in the seasonings that contain allergens to prevent allergen cross-contact during manufacturing. The John Paine’s Steak Beast Unleashed All Purpose Rub, Net. Wt. 12oz. bears a label that contains an allergen statement that reads in part: “***Contains Dairy.***”; however, the ingredient list for this product did not include butter powder as an ingredient, which contains a major allergen, milk.
b. For your RTE seasoning products, you did not identify and evaluate contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is hazard requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Your facility manufactures RTE seasoning products which are exposed to the environment during blending and filling. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR § 117.135(c)(3)). In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)).
You do not have appropriate controls in place for contamination with environmental pathogens. You stated that you use Mrs. Meyer’s Clean Day Multi-Surface Concentrate as the main cleaning solution for cleaning all areas of the facility including food-contact surfaces. This is labeled as a household cleaner, not for use on food-contact equipment in a food manufacturing facility. You further stated that you do not use any sanitizers at your facility, such as for food-contact surfaces.
c. You did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE seasoning products made from onion powder, garlic powder, white pepper, paprika, cayenne pepper and celery powder which have been associated with vegetative bacterial pathogens such as Salmonella. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial pathogens as a hazard requiring a preventive control. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as Salmonella, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (See 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410).
You do not have an appropriate supply-chain program in place. For example, you do not approve suppliers or conduct appropriate supplier verification activities for the manufacturing of John Paine’s Steak Beast Unleashed All Purpose Rub (Lot: JPUL230216004), which consists of salt, brown sugar, onion powder, garlic powder, white pepper, black pepper, paprika, cayenne pepper, celery powder, and hickory smoke seasoning. Salmonella in RTE seasoning products is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii)).
d. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures and repackages RTE seasoning products made from white pepper, cayenne pepper, and paprika. These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/ processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). You do not have this program in place.
In your May 3, 2023, response, you included a written contract from a third-party consultant, signed May 1, 2023, to “write and implement your FDA-compliant Food Safety Program for repacking dry spices, herbs, teas and superfoods, train you and assure your operation is fully compliant with all FDA requirements.” The contract also stated, “all FDA-compliant Food Safety Program documentation to be completed within 3 weeks of receiving back a signed proposal, a deposit payment and a completed client intake questionnaire.” We cannot fully evaluate your response because you did not submit the completed food safety program or how you will assure that your facility is compliant with all FDA requirements.
Misbranded Foods
1. Your John Paine’s Steak Beast Unleashed All Purpose Rub product is misbranded within the meaning of 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen “milk” as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines a major food allergen as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as any food ingredient that contains protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded 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 is 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, except that 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, 21U.S.C. § 343(w)(1)(B)].
Specifically, your Steak Beast Unleashed All Purpose Rub is manufactured using butter powder, which contains milk. However, “milk” is not declared in the ingredient statement, and the “Contains” statement does not declare the common or usual name of the food source from which the major food allergen is derived. The term “dairy” is not the appropriate name of the food source that must be used in the “Contains” statement.
2. Your John Paine’s Steak Beast Beasty Bird is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the common or usual name of the food. The statement of identity “Beasty Bird” is not provided by law or regulation, is not the common or usual name of a food, and is not appropriately descriptive, as required by 21 CFR 101.3(b).
3. Your John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products bear or contain an artificial coloring but do not bear labeling stating that fact. Specifically, the formulation for Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub lists “color – orange” as an ingredient, and the Beasty Bird formulation lists “color – red” as an ingredient. However, none of the product labels declare the artificial color in the ingredient statements. Note that if these color additives are certified, they must be declared in accordance with the 21 CFR 74, Listing of Color Additives Subject to Certification.
4. Your John Paine’s Steak Beast Beasty Bird, Unleashed All Purpose Rub, Steak Seasoning, and Pork Rub products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label in descending order of predominance by weight in the finished food. Specifically,
a. Your Beasty Bird formulation indicates “brownulated (sic) sugar” is the predominant ingredient; however, the ingredient statement on the product label declares salt as the first ingredient. According to 21 CFR 101.4(a)(1), ingredients shall be listed by their common or usual name in descending order of predominance by weight. The formulation also lists the following ingredients that are not declared on the label: celery salt (the label only lists “celery”), white pepper, cayenne pepper, and hot paprika.
b. Your Unleashed All Purpose Rub formulation lists butter powder as an ingredient; however, this ingredient is not declared on the label, as required by 21 CFR 101.4. Additionally, the Unleashed All Purpose Rub formulation indicates the product is made from one part Unleashed and two parts Steak Beast Original seasoning, which also includes the following ingredients that are not declared on the Unleashed All Purpose Rub label: sugar (only "brown sugar” is declared on the label), black pepper, white pepper, cayenne pepper (the label only lists “pepper”), and celery salt.
c. Your Steak Beast Steak Seasoning formulation includes the following ingredients that are not declared on the product label: celery salt (as the label only lists “celery”), white pepper, and cayenne pepper. Note that the formulation does not include onion powder, but the label declares onion powder.
d. Your Chop Beast Pork Rub formulation includes the following ingredients that are not declared on the product label: celery salt (the label only lists “celery”), and white pepper.
e. Your Beasty Bird, Unleashed All Purpose Rub, Steak Beast Steak Seasoning, and Chop Beast Pork Rub formulations include celery salt as an ingredient. If celery salt is a multi-component ingredient, each ingredient of the celery salt must also be declared.
5. Your John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that they fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5
6. Your John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, Unleashed All Purpose Rub), and Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g., Nutrition Facts label, “NFL”) is not in accordance with the requirements under 21 CFR 101.9. Specifically,
a. The nutrients declared in the NFLs are not in accordance with 21 CFR 101.9(c). For example:
i. The NFLs on the John Paine’s Steak Beast products do not include the following required information: Total Sugars (rather than Sugars), Added Sugars, Vitamin D, Calcium, Iron, and Potassium, as required by 21 CFR 101.9(c).
ii. The NFLs on the Dr. Botanical Health products do not include Sodium, Total Carbohydrates, Dietary Fiber, Total Sugars, Added Sugars, Vitamin D, Calcium, Iron, and Potassium, as required by 21 CFR 101.9(c).
b. The NFL format is not in accordance with 21 CFR 101.9(d). For example:
i. The labels on the John Paine’s products use a footnote not provided for in 21 CFR 101.9(d)(9).
ii. The declaration of Calories from Fat on the John Paine’s product labels is no longer permitted in the updated NFL.
iii. The heading “Nutrition Facts Per 12 oz (340g)” on the John Paine’s product labels is not in accordance with 21 CFR 101.9(d)(2).
iv. The heading “Nutrition Facts Per 100g Bag” on the Dr. Botanical Health product labels is not in accordance with 21 CFR 101.9(d)(2).
v. The John Paine’s product labels declare a “Servings Per Package” of 227 servings, a serving size of “¼ tsp (5g),” and net quantity of contents of “12oz (340g).” The information in the NFL appears to be incorrect because 227 x 5g servings equates to 1,135g, which does not equal the net quantity of contents declared on the label.
c. The NFLs of the Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder include the ingredient statements. The NFL requirements under 21 CFR 101.9 does not provide for the inclusion of the ingredient statements. The ingredient statements must be separately declared on the principal display panel (PDP) or the information panel, in accordance with 21 CFR 101.4.
d. The Calories declarations on both the Dr. Botanical Health products are not expressed in the appropriate units and/or increments as required by 21 CFR 101.9(c). Additionally, the Organic Lion’s Mane Carbohydrates declaration is also not expressed in the appropriate units and/or increments.
e. The Dr. Botanical Health product labels fail to list the percent daily values (%DV), as required by 21 CFR 101.9(c).
7. Your John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub) are misbranded within the meaning of section 403(e)(2) [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel, as required by 21 CFR 101.7(a).
8. Even if your Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products were not unapproved new drugs and misbranded drugs, they 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 bear 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 in 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, your Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products bear the claim “Powerful Antioxidant.” Nutrient content claims using the term “antioxidant” must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(1)], and these nutrients must have recognized antioxidant activity [21 CFR 101.54(g)(2)]. The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), as required by 21 CFR 101.54(g)(3). In addition, such a claim must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term “antioxidant” or “antioxidants” may be linked 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 [21 CFR 101.54(g)(4)].
Your claim “Powerful Antioxidant” does not include the names of the nutrients that are the subject of the claim, or link the nutrients with the claim by use of a symbol.
Your Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder also bears the nutrient content claim “Rich in Vitamins & Nutrients,” but the product does meet the requirements to bear the claim. In accordance with 21 CFR 101.54(b), the terms “rich in,” “high,” or “excellent source of” may be used to characterize the level of a nutrient on the label and in the labeling of foods, provided that the food contains 20 percent or more of the RDI or Daily Reference Value (DRV) per reference amount customarily consumed. However, your product label does not list any vitamins and does not specify which nutrients the product is “rich in.”
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We also have the following comments on your Dr. Botanical Health products:
- Your Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products are marketed as conventional foods. For example, you have included a “Nutrition Facts” panel on the product labels. However, these labels also contain the statement, “Statements regarding dietary supplement have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent and [sic] disease or health condition.” To the extent you intend these products to be conventional foods, you should not refer to them as dietary supplements. We note that, under section 201(ff)(2)(B) of the Act, a dietary supplement “means a product that . . . is not represented for use as a conventional food or as a sole item of a meal or the diet.”
- For your Dr. Botanical Health product labels, the provisions in 21 CFR 101.7(j)(3) state that the term “net weight” must be used when stating the net quantity of contents in terms of weight. In addition, the regulation does not provide for the term “servings” as part of the net quantity of contents statement.
- The statement of the place of business must include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. 21 CFR 101.5(d). Please note that the regulation does not provide for the use of PO Box in lieu of a street address.
- We note that the product labels for your Dr. Botanical Health products bear the disclaimer, “May be packaged in a facility that also packs nuts.” Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls. See Questions and Answers
Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry. The firm should make every effort to ensure that they and their suppliers have adequate GMP's in place to prevent the unintentional inclusion of allergens in their products and ingredients.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to René R. Ramirez, Compliance Officer, U.S. Food and Drug Administration One Main Place, 1201 Main Street, STE 7200, Dallas, TX 75202, or via email at rene.ramirez@fda.hhs.gov. If you have any questions regarding the content of this letter, please contact Mr. Ramirez at 210-308-1425 or rene.ramirez@fda.hhs.gov.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
