As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Lone Star Botanicals Inc.
Tyler, TX
A food firm in Texas is on notice from the FDA after an inspection at its food manufacturing facility found violations of various federal regulations, including unapproved new drugs and misbranded drugs, hazard analysis and risk-based preventive controls, and misbranded foods.
In a Nov. 6, 2023 warning letter, the FDA described an April 17-21, 2023 inspection of Lone Star Botanicals Inc.’s food manufacturing facility in Tyler, TX.
The FDA’s inspection found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.
They determined that the ready-to-eat (RTE) seasoning products manufactured in the firm’s facility are adulterated as they were prepared, packed, or held under insanitary conditions where they may have become contaminated with filth or rendered injurious to health.
After the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations.
Some of the significant violations are as follows:
Unapproved New Drugs and Misbranded Drugs
FDA reviewed the firm’s website at the Internet address https://drbotanicalhealth.com/ in July 2023 and Oct. 2023 and has determined that they take orders there for their 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 the firm’s product labels collected during the inspection for their 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 their Dr. Botanical Health Product Brochure, which directs consumers to their website https://drbotanicalhealth.com/ to purchase their products. The claims on their website, product labels, and product brochure establish that the products are drugs 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 their 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 their product labels that provide evidence that their 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 their Dr. Botanical Health Product Brochure that provide evidence that their 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 ….”
Hazard Analysis and Risk-Based Preventive Controls:
1. The firm did not prepare, or have prepared, and implement a food safety plan. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). Their food safety plan must also include the following:
1) The written hazard analysis;
2) The written preventive controls;
3) The written supply-chain program;
4) The written recall plan;
5) The written procedures for monitoring the implementation of the preventive controls;
6) The written corrective action procedures; and
7) The written verification procedures.
However, the firm did not have a food safety plan with any of the required elements. For example, they 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 their facility to determine whether there are any hazards requiring a preventive control. Also, they 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 their facility will not be adulterated or misbranded. 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. 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. The firm 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. Specifically:
a. The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their 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 their 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.
The firm 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, they 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 their RTE seasoning products, they 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. The firm’s 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 their 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. 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 .
The firm does not have appropriate controls in place for contamination with environmental pathogens. They stated that they 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. They further stated that they do not use any sanitizers at their facility, such as for food-contact surfaces.
c. The firm 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. Their 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 their 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. The supply-chain program must include using approved suppliers and conducting supplier verification activities.
The firm does not have an appropriate supply-chain program in place. For example, they 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. The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter.
d. The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their 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 their 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. The supply-chain program must include using approved suppliers and conducting supplier verification activities. The firm does not have this program in place.
Misbranded Foods
1. The firm’s John Paine’s Steak Beast Unleashed All Purpose Rub product is misbranded in that the finished product label fails to declare the major food allergen “milk.”
2. The firm’s John Paine’s Steak Beast Beasty Bird is misbranded 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.
3. The firm’s John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded 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.
4. The firm’s John Paine’s Steak Beast Beasty Bird, Unleashed All Purpose Rub, Steak Seasoning, and Pork Rub products are misbranded 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.
5. The firm’s John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded in that they fail to list the name and place of business of the manufacturer, packer or distributor.
6. The firm’s 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 in that the nutrition information (e.g., Nutrition Facts label, “NFL”) is not in accordance with the requirements.
7. The firm’s John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub) are misbranded because the labels fail to declare the net quantity of contents on the principal display panel.
8. Even if the firm’s 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 because the product labels bear nutrient content claims, but the products do not meet the requirements to bear such claims. 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.
The full warning letter can be viewed here.
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