WARNING LETTER
Spartan Enterprises Inc. dba Watershed Wellness Center
MARCS-CMS 642030 —
March 08, 2023
Delivery Method:
Via Email
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Robert F. McCauley
Recipient Title
President/Owner
Spartan Enterprises Inc. dba Watershed Wellness Center
16280 National Parkway
Lansing
,
MI
48906
United States
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
FY23-HAFE6-01 CMS 642030
March 8, 2023
Dear Mr. McCauley:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 16280 National Parkway, Lansing MI, from June 29 through July 25, 2022. We also reviewed your websites at www.watershed.net and www.shop.watershed.net in December 2022, and your YouTube channel. Based on inspectional findings 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 can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
Unapproved New/Misbranded Drugs
This is to advise you that the FDA reviewed your product labels following the inspection of your facility. In addition, FDA reviewed your website www.shop.watershed.net in December 2022, and determined you take orders there for the products Dr. Bob’s Naturals Spirulina, Dr. Bob’s Naturals Magtein, Dr. Bob’s Naturals Tulsi-Holy Basil Extract Capsules, Dr. Bob’s Naturals Milk Thistle Liver Support, Dr. Bob’s Naturals Stone Breaker Powder, Dr. Bob’s Parasite Killer, Dr. Bob’s Naturals Parasite Killer Bundle, Dr. Bob’s Naturals Parasite Killer Bundle MINI, Dr. Bob’s Naturals Yew VeggieCaps, Dr. Bob’s Naturals Gingko Magic, and Dr. Bob’s Naturals Chlorella, and Raw Food World Ashwagandha Extract. We also reviewed your website www.watershed.net, which directs consumers to your website www.shop.watershed.net to purchase your products, and your YouTube Channel at www.youtube.com/c/DrBobMcCauley, in December 2022. The claims on your product labels, websites, and your YouTube Channel establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.SC. § 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 for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
From your website at www.watershed.net:
o
Spirulina [an ingredient in Dr. Bob’s Naturals Spirulina tablets]:
the following statements are included in the description: “Lowers LDL and Triglyceride Levels”, “Anti-Inflammatory Properties”, “Fights Anemia”
o
Ashwagandha [an ingredient in the Raw Food World Ashwagandha Extract]:
the following statements are included in the description: “It is commonly used to relieve…pain, skin, joint, digestive issues asn [sic] well as neurological issues.”
From your website at www.shop.watershed.net:
o
Dr. Bob’s Naturals Magtei:
“Magnesium repairs the damaged synapses of the brain, which is the cause of the various types of neurological and brain-related diseases.”
o
Dr. Bob’s Naturals Tulsi-Holy Basil Extract Capsules:
o “Regulates Insulin Levels to Help Balance Blood Sugar”
o “Contains Antibacterial, Antifungal Properties”
o “Holy Basil…regulates insulin levels…. It has Antibacterial, anti-fungal, and anti-inflammatory properties.”
o
Dr. Bob’s Naturals Milk Thistle Liver Support:
o “Milk Thistle ….is…anti-inflammatory”
o “Benefits:
􀂃 Reduces Cholesterol
􀂃 Anti-allergic
􀂃 Asthma Support
􀂃 Reduces Insulin Resistance
􀂃 Anti-inflammatory”
o
Dr. Bob’s Naturals Stone Breaker Powder:
“Stone Breaker (Chanca Piedra) has been used by the indigenous peoples of the Amazon Forests for centuries to treat and remove of [sic] kidney and gall stones. It helps dissolve the stones so they can be eliminated from the body. Chanca Piedra interferes with stone formation by relaxing urinary passages so small stones are more easily passed. It can be used in conjunction with lithotripsy, a shock wave procedure that fragments stones”
o
Dr. Bob’s Naturals Parasite Killer Bundle:
“Six Products that kill viruses, bacteria, yeast, mold, and fungus in the bloodstream and digestive tract. Silver: Kills viruses, bacteria, yeast, mold, and fungus in the bloodstream. (16 oz) Bismuth: Kills bacteria in the digestive tract. (16 oz) Papaya Seed Powder: Parasite removal. Parasite Killer BlendTM: Kills viruses, bacteria, yeast, mold, and fungus in the digestive tract. Dissolve Bioactive Silicate: Removes biofilm and nano-bacteria from the arteries and body. Proferment [sic].”
o
Dr. Bob’s Naturals Parasite Killer Bundle MINI:
“Dr. Bob’s Parasite Killer Bundle MINI is identical to Dr. Bob’s Parasite Killer Bundle except the bottles are 2 oz (NOT 16 oz). Six Products that kill viruses, bacteria, yeast, mold, and fungus in the bloodstream and digestive tract. Silver: Kills viruses, bacteria, yeast, mold, and fungus in the bloodstream. (2 oz) Bismuth: Kills bacteria in the digestive tract. (2 oz) Papaya Seed Powder: Parasite removal. Parasite Killer Blend
TM
: Kills viruses, bacteria, yeast, mold, and fungus in the digestive tract. Dissolve Bioactive Silicate: Removes biofilm and nano-bacteria from the arteries and body. Preferment – Probiotic.”
o
Dr. Bob’s Naturals Parasite Killer:
“Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and antibacterial ingredients with the intention of killing everything in the digestive tract. Once that is accomplished then the next step is to reintroduce probiotics, the friendly bacteria that…. keep our digestive tract free of parasites and unhealthy bacteria.”
From your YouTube Channel:
o
A video titled “Amazing herb – Little Known: YEW Tree with Taxane” [an ingredient in Dr. Bob’s Naturals Yew VeggieCaps]
at https://www.youtube.com/watch?v=kudldIcMIXU, in which the URL for your website www.watershed.net appears onscreen during the video and you state: “Very powerful anti-cancer properties…used in conjunction with chemotherapy and other cancer treatments, but not only does it have anti-cancer properties it also has a lot of other properties as well…the way that Taxane works in the body to fight cancer is it causes cell apoptosis in cancer cells. So it doesn’t allow the cancer cell to replicate…. Is also very powerful anti-inflammatory…on top of being anti-cancer…. you take two or three capsules a day as a maintenance dosage, or if you have a serious health challenge maybe you got cancer or something, you’re going to triple that dosage and do three of those three times a day ….”
o Your description of the video says, “Buy Yew Capsules Here” and hyperlinks to the Dr. Bob’s Naturals Yew VeggieCaps product page of your website, https://shop.watershed.net/index.php/herbal-extracts/immune-system-builder/yew/yewcaps.html, and also contains the following written statements:
􀂃 “Anti-inflammatory”
􀂃 “Taxane a chemical substance derived from a yew tree of the Pacific Coast: used yew tree experimentally as a drug in the treatment of cancer. It is derived from Yew trees – Taxus Brevafolia – and bushes and used to kill dividing cells, especially tumor cells.”
􀂃 “The taxanes are mitotic inhibitors, meaning that they inhibit tumors primarily by preventing cells from entering mitosis, a process of cell division. The taxanes accomplish this by inhibiting microtubule polymerization. In addition, taxanes appear to stimulate apoptosis, or programmed cell death, which is often inhibited in cancer cells.”
o
A video titled “Gingko Biloba Benefits” [an ingredient in Dr. Bob’s Naturals Gingko Magic]
at https://www.youtube.com/watch?v=6SstxpuWwZg, in which the URL for your website www.watershed.net appears onscreen during the video and you state: “It’s used for Alzheimer’s, memory loss ….Good for…ADHD ….It also helps with…arthritis….It also helps with…asthma…it is opening up those bronchial tubes and increasing circulation to the lungs….gingko biloba world’s most famous herb use for all your…fibromyalgia…increasing that circulation to relieve that pain…be good for MS [multiple sclerosis] as well for that reason….”
o During the video, the following written statements appear as on-screen text:
􀂃 “Reduces Risk for Dementia/Alzheimer’s”
􀂃 “Helps fight Fibromyalgia”
􀂃 “Helps fight Headaches/Migraines”
o Your description of the video says, “Buy Our Ginkgo Veggie Capsules Here” and hyperlinks to your website https://shop.watershed.net/index.php/herbal-extracts/brainhealth/gingko-biloba/ginkgo-veggiecaps.html, and also contains the following written statements:
􀂃 “Helps fight Headaches/Migraines”
􀂃 “Reduces Memory Loss”
􀂃 “Helps fight Muscle and Nerve Pain”
o
A video titled “Increase your Synaptic Activity with Magnesium for the Brain” [an
ingredient in Dr. Bob’s Naturals Magtein]
at https://www.youtube.com/watch?v=AoZv9ESLFpY, in which the URL for your website www.watershed.net appears onscreen during the video and you state: “[m]agnesium…a lot of people have heart attacks just because they are short on magnesium….there’s another type of magnesium that gets to your brain….they started autopsying Alzheimer’s patients after they passed away and stupid monkeys and smart monkeys and they found the people with the Alzheimer’s and stupid monkeys had absolutely no magnesium in the brain and smart monkeys were full of magnesium in the brain. Well what does that tell you? Magnesium is really needed in the brain it increases synaptic activity and actually increases synapses themselves in the brain.”
o During the video, the following written statement appears as on-screen text:
􀂃 “6 grams (2 tsp or 12 capsules) per day if you have memory issues or DEMENTIA”.
o Your description of the video hyperlinks to the Dr. Bob Naturals Magtein product page of your website, https://shop.watershed.net/index.php/supplements/magtein/magtein-miracle-magnesium-for-the-brain-veggie-capsules.html, and contains the following written statements:
􀂃 “Magnesium repairs the damaged synapses of the brain.”
􀂃 “Decreases the Onset Of Memory Loss”
􀂃 “Repairs Damaged Synapses”
From your product labels:
o
Dr. Bob’s Naturals Ginkgo Magic:
“Ginkgo is an anti-inflammatory”
o
Dr. Bob’s Naturals Yew VeggieCaps:
“The Yew tree (taxus brevifolia) contains a substance called taxane. Taxanes . . . prevent harmful cells from entering mitosis. Taxane has been used in chemotherapy for many years.”
o “Anti-Inflammatory”
o
Dr. Bob’s Naturals Parasite Killer:
“Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral and anti-bacterial ingredients with the intention of killing everything in the digestive tract.”
o
Dr. Bob’s Naturals Spirulina:
“Helps Balance Blood Sugar”
o
Dr. Bob’s Naturals Chlorella:
“Helps Balance Blood Sugar”
o
Dr. Bob’s Holy Basil Extract:
“Tulsi, or Holy Basil…. regulates insulin helping balance blood sugar levels in the body. It also contains antibacterial, antifungal, and anti-inflammatory properties.”
o
Dr. Bob’s Naturals Milk Thistle Liver Support:
“Milk Thistle …. is also…anti-inflammatory ….”
o “Reduces Cholesterol
o Reduces Insulin Resistance
o Anti-Inflammatory
o Asthma Support”
o
Dr. Bob’s Naturals Stone Breaker Capsules:
“Gall and Kidney Stone Removal”
o “Stone Breaker (Chanca Piedra) has been used…to treat and remove kidney and gall stones. It helps dissolve the stones …. Chanca Piedra interferes with stone formation by relaxing urinary passages so small stones are more easily passed.”
Your 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 used safely at the direction, and under the supervision, of a licensed practitioner.
Your Dr. Bob’s Naturals Yew VeggieCaps, Gingko Magic, Milk Thistle Liver Support, Stone Breaker Capsules and Powder, and Magtein 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. Bob’s Naturals Yew VeggieCaps, Gingko Magic, Milk Thistle Liver Support, Stone Breaker Capsules and Powder, and Magtein 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)].
Adulterated Dietary Supplements
The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR 111). Based on these violations, your Dr. Bob’s Naturals NootriTonic ULTRA, Dr. Bob’s Naturals Parasite Killer, and Raw Food World Sleep Deep Powder products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they were prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
The violations include the following:
1. You failed to establish specifications required under 21 CFR 111.70. Specifically:
a. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). For example, Chanca Piedra is an ingredient in your Dr. Bob’s Naturals Parasite Killer, but you did not establish such component specifications for Chanca Piedra. Likewise, Yuan Zhi is an ingredient in your Raw Food World Sleep Deep powder, but you did not establish such component specifications for Yuan Zhi.
b. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or lead to the adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). For example, you did not establish any finished product specifications for Dr. Bob’s Naturals NootriTonic ULTRA, Raw Food World Sleep Deep Powder, and Dr. Bob’s Naturals Parasite Killer.
Once you have established specifications required under 21 CFR 111.70, you must determine whether the specifications are met, as required by 21 CFR 111.75. You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).
We have reviewed your responses, dated August 12 and August 23, 2022, in which you state you will establish specifications for the purity, strength, and composition of each of the ingredients used in your supplements, and that you will develop procedures to demonstrate that the products you manufacture meet your specifications. We also reviewed your January 22, 2023, response in which you state you have overhauled and improved your document protocols. However, you did not provide any supporting documentation, such as copies of your specifications. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that you have established component and finished product specifications.
2. You must prepare and follow a master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a), and the MMR must include the information required under 21 CFR 111.210. The MMRs used in the manufacture of your Dr. Bob’s Naturals NootriTonic ULTRA, Raw Food World Sleep Deep Powder, and Dr. Bob’s Naturals Parasite Killer, failed to include the following information, as required by 21 CFR 111.210:
a. The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label [21 CFR 111.210(d)].
b. A statement of theoretical yield of a manufactured dietary supplement at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)].
c. A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
d. Written instructions, including specifications for each step, point or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h)(1)].
e. Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
f. Written instructions, including specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h)(3)].
g. Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
In addition, the MMRs for Dr. Bob’s Naturals Parasite Killer and Raw Food World Sleep Deep Powder also do not include the strength, concentration, weight, or measure of each dietary ingredient for each batch size [21 CFR 111.210(a)] and an accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)], nor does the MMR for Dr. Bob’s Naturals Parasite Killer include a complete list of components to be used [21 CFR 111.210(b)].
We have reviewed your responses dated August 12, 2022, and August 23, 2022, in which you state you will develop written instructions and include them with your MMRs to reflect your procedures in greater detail, including quality control points, manufacturing stages, reserve collection and storage. You also state that you will implement in writing detailed manufacturing procedures, including which utensils are used, and how they should be cleaned and properly stored. We also reviewed your January 22, 2023, response in which you state you have overhauled and improved your document protocols. However, you did not provide any supporting documentation, such as copies of revised MMRs for your products. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that you revised your MMRs and that they are compliant with 21 CFR 111.210.
3. You must prepare a batch production record (BPR) every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a), and the BPR must include the information required under 21 CFR 111.260. The BPRs you provided for your Raw Food World Sleep Deep (Lots 8070, 8079), Dr. Bob’s Naturals Parasite Killer (Lots 7036, 7087), and Dr. Bob’s Naturals NootriTonic ULTRA (Lots 8067, 8044) dietary supplements lacked the following information that must be included in a BPR, as required by 21 CFR 111.260:
a. The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
b. The date and time of maintenance, cleaning and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records where this information is retained [21 CFR 111.260(c)].
c. The unique identifier that you assigned to each component, packaging, and label used [21 CFR 111.260(d)].
d. The identity and weight or measure of each component used [21 CFR 111.260(e)].
e. A statement of the actual yield or statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
f. The actual results obtained during any monitoring operations [21 CFR 111.260(g)].
g. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)].
h. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)].
i. Documentation, at the time of performance, of the manufacture of the batch, including the information required under 21 CFR 111.260(j) [21 CFR 111.260(j)].
j. Documentation, at the time of performance, of packaging and labeling operations, including the information required under 21 CFR 111.260(k) [21 CFR 111.260(k)].
k. Documentation at the time of performance, that quality control personnel reviewed the batch production record, and approved and released, or rejected, the batch for distribution [21 CFR 111.260(l)(3)].
l. Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)].
We have reviewed your responses, dated August 12 and August 23, 2022, in which you state you will keep detailed cleaning and sanitation records for each production run of any supplement you are manufacturing, that cleaning procedures in sanitation records will become part of all your SOPs, and that each batch record will reflect what cleaning and sanitation was done before and after the batch was manufactured. We also reviewed your January 22, 2023, response in which you state you have overhauled and improved your document protocols. However, you did not provide any supporting documentation, such as copies of BPRs for your products. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that you have revised your BPRs and that they are compliant with 21 CFR 111.260.
4. You failed to maintain your physical plant in a clean and sanitary condition, as required by 21 CFR 111.15(b)(1). Specifically:
a. In your repacking room, there was green residue built up on a ceiling vent for the A/C unit, on the protective grating on a ceiling vent, and on various ceiling tiles. Further, your “Weekly Cleaning Procedure” includes wiping down walls and vents but does not include instructions for cleaning the ceiling tiles.
b. In your new packing room, there were several multicolored stains on the walls of the room that were in direct contact with the table used for manufacturing powdered and capsuled dietary supplements. There was dark brown residue built up on a ceiling vent for the A/C unit. You stated during the inspection that this room is used to repack and manufacture dietary supplements such as Dr. Bob’s Naturals Parasite Killer and to repack food products such as your Empress Blend mix, which contains raw pistachios. You provided two cleaning procedures for this room during the inspection, neither of which contains instructions for preventing allergen cross-contact, nor were you able to provide evidence of implementation of either of these procedures.
c. In the warehouse our investigator observed a lawn mower, a snow blower, three orange gas containers, four bags of weed killer (one of which was opened), two canisters of pest control spray, two containers of engine/motor oil, and assorted lawn and gardening equipment that were directly touching or immediately surrounding a number of your products.
We have reviewed your responses and acknowledge that in your August 23, 2022, response you indicated that the green and brown residues are caused when you do not change filters often enough, and that you will change the filters in the rooftop/heating and cooling unit.
In addition, you stated that you cleaned the wall that had the stain on it. You also stated that all gasoline, oil, and other petroleum products have been removed from the building entirely and that you have hired a contractor to maintain the outside of the facility. However, you did not provide evidence of corrective actions, such as photographs of replaced filters, cleaned ceiling tiles and vents, and the warehouse. Further, your response did not indicate that you would update your cleaning and/or maintenance procedures to include cleaning ceiling tiles and a filter replacement schedule, nor did you provide a copy of updated cleaning and/or maintenance procedures. Therefore, we are unable to evaluate the adequacy of your corrective action.
5. Your quality control personnel did not approve or reject written procedures that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically, during the inspection, we reviewed your “Production Quality Control SOP,” “Incoming Quality Control (IQC) SOP,” “Finished Batches Meeting Product Specifications SOP,” and none of these procedures included a signature from your quality control personnel. Likewise, your quality control personnel did not approve all MMRs, as required by 21 CFR 111.123(a)(1). Specifically during the inspection, we reviewed the MMRs for Dr. Bob’s Naturals NootriTonic ULTRA (50g), Raw Food World Sleep Deep Powder (2 oz.), and Dr. Bob’s Naturals Parasite Killer (60 capsules), and none of these MMRs included a signature from your quality control personnel.
We have reviewed your responses dated August 12, 2022, and August 23, 2022, in which you state you will implement a more detailed quality control protocol and that you are working with a consultant to make the necessary corrections in your current system. We also reviewed your January 22, 2023, response in which you state you have overhauled and improved your document protocols. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that your quality control unit is reviewing and approving your written procedures and master manufacturing records.
Misbranded Dietary Supplements
Even if your Dr. Bob’s Naturals Ginkgo Magic, Yew VeggieCaps, and Parasite Killer products were not unapproved new drugs, the products would be misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. Additionally, your Dr. Bob’s Naturals NootriTonic ULTRA and The Raw Food World Sleep Deep Powder products also do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:
1. Your Dr. Bob’s Naturals Ginkgo Magic, Dr. Bob’s Naturals Yew VeggieCaps, Dr. Bob’s Naturals NootriTonic ULTRA, Dr. Bob’s Naturals Parasite Killer, and The Raw Food World Sleep Deep Powder products are each 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.
2. Your Dr. Bob’s Naturals Ginkgo Magic, Dr. Bob’s Naturals Yew VeggieCaps, Dr. Bob’s Naturals NootriTonic ULTRA, Dr. Bob’s Naturals Parasite Killer, and The Raw Food World Sleep Deep Powder products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because they do not include a statement of identity as a “dietary supplement,” as required by 21 CFR 101.3(g).
3. Your Dr. Bob’s Naturals Yew VeggieCaps, Dr. Bob’s Naturals Parasite Killer, Dr. Bob’s Naturals NootriTonic ULTRA, and The Raw Food World Sleep Deep Powder 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 all common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically:
a. The Dr. Bob’s Naturals Yew VeggieCaps and Dr. Bob’s Naturals Parasite Killer products are manufactured into capsules, but the label fails to declare the ingredients that form the capsule itself.
b. The Dr. Bob’s Naturals Yew VeggieCaps product label fails to declare the standardized common name of Pacific Yew for the declared dietary ingredient
Taxus brevifolia
(“Yew powder”), as listed in the reference Herbs of Commerce.
c. The Raw Food World Sleep Deep Powder product label fails to declare the standardized common name of polygala for the declared dietary ingredient
Yuan zhi
. Additionally, the product label fails to declare the standardized common name of oriental arborvitae for the declared dietary ingredient bai zi ren (
Platycladus orientalis
).
d. The Dr. Bob’s Naturals NootriTonic ULTRA product label fails to declare the common or usual name for alpha-GPC, fruit punch flavor, and P5P.
e. The Dr. Bob’s Parasite Killer fails to declare the standardized common name for the ingredients “Mimosa Pudica” and “Chandra Piedra” as listed in Herbs of Commerce. Mimosa Pudica is not a standardized common name, but an other common name. In addition, we note that your website indicates that “Chandra Piedra’ is an unidentified species of
Phyllanthus
.
4. The Raw Food World Sleep Deep Powder product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the product label fails 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.
5. Your Dr. Bob’s Naturals Ginkgo Magic, Dr. Bob’s Naturals Yew VeggieCaps, Dr. Bob’s Naturals NootriTonic ULTRA, Dr. Bob’s Naturals Parasite Killer, and The Raw Food World Sleep Deep Powder products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the products are derived, as required by 21 CFR 101.4(h)(1). Specifically:
a. The Dr. Bob’s Naturals Ginkgo Magic product label fails to include the part of the plant from which the Ginkgo biloba extract is derived.
b. The Dr. Bob’s Naturals Yew VeggieCaps product label fails to include the part of the plant from which the Yew powder is derived.
c. The Dr. Bob’s Naturals Parasite Killer product label fails to include the part of the plant from which its botanical ingredients are derived, including clove powder, wormwood, guarana, bearberry, epazote, and “mimosa pudica.”
d. The Raw Food World Sleep Deep Powder product label fails to declare in English the part of the plant from which the bai zi ren and yuan zhi are derived.
6. Your Dr. Bob’s Naturals Ginkgo Magic, Dr. Bob’s Naturals Yew VeggieCaps, and Dr. Bob’s Naturals Parasite Killer products are misbranded within the meaning of section 403(q)(1)(A) [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Specifically:
a. The dosage amount listed on Dr. Bob’s Naturals Ginkgo Magic product label suggest the consumer take a “maintenance dosage” of 2-4 capsules daily or a “health challenge” dosage of 5-8 capsules daily, but the serving size listed is 2 capsules.
b. The dosage amount listed on Dr. Bob’s Naturals Yew VeggieCaps product label suggests the consumer take a “maintenance dosage” of 2 capsules daily or a “health challenge” dosage of 5-8 capsules daily, but the serving size listed is 2 capsules.
c. The dosage amount listed on Dr. Bob’s Naturals Parasite Killer product label indicates two to four capsules on an empty stomach. Furthermore, the serving size of 750 mg in the Supplement Facts label does not correlate with the dosage declaration.
7. Your Dr. Bob’s Naturals Ginkgo Magic, Dr. Bob’s Naturals Yew VeggieCaps, Dr. Bob’s Naturals NootriTonic ULTRA, Dr. Bob’s Naturals Parasite Killer, and The Raw Food World Sleep Deep Powder products are misbranded within the meaning of sections 403(q)(5)(F) and 403(q)(1)(A) of the Act [21 U.S.C. §§ 343(q)(1)(A) and (q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36.
Specifically:
a. Dr. Bob’s Naturals Ginkgo Magic:
i. The product label lists its dietary ingredient, ginkgo biloba extract, outside the nutrition label of the supplement facts label. This dietary ingredient should be listed inside the supplement facts label along with its quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).
ii. The product label declares nutrients with quantitative amounts of zero. Any (b)(2)-dietary ingredients not present, or in amount that can be declared as zero in 21 CFR 101.9(c), shall not be declared, in accordance with 21 CFR 101.36(b)(2).
b. Dr. Bob’s Naturals Yew VeggieCaps
i. The product label lists its dietary ingredient, “yew powder”, outside the nutrition label of the supplement facts label. This dietary ingredient should be listed inside the supplement facts label along with its quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).
ii. The product label contains nutrients which may be declared as zero. Any (b)(2)-dietary ingredients not present, or in amount that can be declared as zero in 21 CFR 101.9(c), shall not be declared, in accordance with 21 CFR 101.36(b)(2).
c. Dr. Bob’s Naturals NootriTonic ULTRA
i. The product label lists dietary ingredients, including alpha-GPC, tyrosine, phosphatidylserine, theanine, carnitine, and P5P, outside the nutrition label of the supplement facts label. These dietary ingredients should be listed inside the supplement facts label along with each dietary ingredient’s quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).
ii. The product label declares dietary ingredients with quantitative amounts of zero. Any (b)(2)-dietary ingredients not present, or in amounts that can be declared as zero in 21 CFR 101.9(c), shall not be declared, in accordance with 21 CFR 101.36(b)(2).
iii. The serving size for the product must be expressed in common household measures as set forth in 21 CFR 101.9(b) and must be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams).
iv. The title, “Supplement Facts,” is not in bolded font nor set at full width of the nutrition label in accordance with 21 CFR 101.36(e)(1).
d. Dr. Bob’s Naturals Parasite Killer product label lists dietary ingredients, including papaya seed, golden seal leaf, clove powder, wormwood, guarana, bearberry, epazote, pumpkin seed, grapefruit seed, “mimosa pudica,” cayenne pepper, and black walnut hull, outside the nutrition label of the supplement facts label. These dietary ingredients should be listed inside the supplement facts label along with each dietary ingredient’s quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).
e. The Raw Food World Sleep Deep Powder product label lists dietary ingredients, including “bai zi ren” and “yuan zhi,” outside the nutrition label of the supplement facts label. These dietary ingredients should be listed as the standardized common name of each dietary ingredient inside the supplement facts label along with its quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).
f. Dr. Bob’s Naturals Ginkgo Magic, Dr. Bob’s Naturals Yew VeggieCaps, and Dr. Bob’s Naturals NootriTonic ULTRA products Supplement Facts labels each declare a statement referencing a 2,000 calorie diet. This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). Furthermore, for the Dr. Bob’s Naturals Yew VeggieCaps there is no provision for the statement “Not a significant source of vitamin D, calcium, iron, and …” in the Supplement Facts label.
8. Your Dr. Bob’s Naturals NootriTonic ULTRA product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. In accordance with 21 CFR 101.7(b)(1), statements of weight shall be in terms of avoirdupois pound and ounce. The net quantity of contents statement, expressed in terms of weight, must specify both metric (i.e., grams or kilograms) and U.S. Customary System (i.e., ounces or pounds), to comply with 21 CFR 101.7 and 15 U.S.C. 1453(a)(2) of the Fair Packaging and Labeling Act.
9. The Dr. Bob’s Naturals Parasite Killer product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product label lists black walnut in the ingredients statement while the “Contains” statement declares that no tree nut is present in the product, which is not in accordance with section 403(w) 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, and soybeans, 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, 21 U.S.C. § 343(w)(1)(B)].
10. Your Dr. Bob’s Naturals Ginkgo Magic, Dr. Bob’s Naturals NootriTonic ULTRA, and The Raw Food World Sleep Deep Powder are each misbranded withing the meaning of section 403(r)(6) [21 U.S.C. § 343(r)(6)] in that the products make structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).
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.
We also have the following comments:
1. You may confirm the identity of other components (that are not dietary ingredients) by relying on a certificate of analysis from the supplier of the component that you receive provided that you:
• First establish component specifications, as required by 21 CFR 111.70(b).
• Meet the requirements of 21 CFR 111.75(a)(2)(ii).
Your Dr. Bob’s Naturals NootriTonic ULTRA product label declares “stevia’ in the Ingredient list. If you are using highly purified steviol glycosides obtained from stevia leaves in your product, please note that “stevia” refers to the botanical and is not the common or usual name of these highly purified ingredients. Rather, the common or usual name for highly purified steviol glycosides depends on the ingredient composition. If the sweetener is purified to contain 95 percent or more of a single steviol glycoside, the specific name of that single steviol glycoside is the common or usual name. For example, the name “rebaudioside A” should be used for ingredients with 95% or more rebaudioside A; the name “stevioside” should be used for ingredients with 95% or more stevioside. If the sweetener is purified to contain 95 percent or more of a mixture of two or more steviol glycosides, the name “steviol glycosides” would be the common or usual name.
2. Your Raw Food World Sleep Deep Powder product displays text in pinyin; pinyin is considered a foreign language. A product is misbranded if the product label contains information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. [section 403(f) of the Act [21 U.S.C. § 343(f)] and 21 CFR 101.15(c)].
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action including, without limitation, seizure and injunction.
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 reply should be addressed to the U.S. Food and Drug Administration; Attn: Lauren Crivellone, Compliance Officer, via email at ORAHAFEAST6FirmResponses@fda.hhs.gov or at 550 W. Jackson Blvd, Chicago, IL 60661. You may reach Ms. Crivellone at 312-206-5264 or via email at Lauren.Crivellone@fda.hhs.gov if you have any questions about this matter.
Sincerely,
/S/
Lawrence Stringer
Acting Program Division Director
Office of Human and Animal Food
Operations Division East 6
Content current as of:
04/25/2023
Regulated Product(s)
Drugs
Food & Beverages