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WARNING LETTER

Scientific Botanicals Company, Inc. 14/11/2014

Scientific Botanicals Company, Inc. - 11/14/2014


Recipient:
Scientific Botanicals Company, Inc.


United States

Issuing Office:
Seattle District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA  98021-4425
 
Telephone:   425-302-0340
FAX:   425-302-0402  

 

November 14, 2014
 
 
VIA CERTIFIED MAIL
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 15-04
 
Edward J. Madison, Owner
Scientific Botanical Company, Inc.
P.O. Box 1663
Mukilteo, Washington 98275
 
WARNING LETTER
 
Dear Mr. Madison:
 
The United States Food and Drug Administration (FDA) conducted an inspection of Scientific Botanicals Company, Inc., located at 8425 44th Avenue West, Mukilteo, Washington, on May 12, 14, 16, and 19, 2014. During the inspection, we collected labeling for your products. Based on our inspection and subsequent review of your product labeling, including your firm’s website, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov. Additionally, you will find guidance materials for manufacturers of dietary supplements.
 
The inspection and our review of your product labeling revealed the following significant violations:
 
Unapproved New Drugs
 
FDA reviewed your websites at the Internet addresses www.scientific-botanicals.com and www.licrogel.com, in November 2014, and has determined that you take orders there for the products “ANANABROM™,” “ANANACUR™,” “CURLONGA™,” “HYDROXO-12™,” “K-QUINONE™,” “MAXIFLAV™,” “PEPLIC™,” “ZINC-PLUS™,” “FOLIRINSE™,” “Licrogel,” “PANTEX,” “AMPEX,” “DOXIGEL,” “CRATOXY™,” “NatexHIP™,” “NatexROOT™,” “beta-PLEX™,” “CYSTASEPTIC™,” “ECHINACEA,” and “TRI-QUENCH™” products, which the websites promote for conditions that cause the products to be   drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites 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 your products are intended for use as drugs include:
 
ANANABROM ™
  • Health Benefits:…Ant-inflammatory…Thrombophlebitis…Upper Respiratory Infections…Scleroderma…”
  • “[I]leitis, Diverticulitis…Gastric, duodenal ulcers.  Circulatory diseases…Potentiation of antibiotics…Arthritis (rheum., osteo.)…Migrains (sic), Bronchial asthma…SEVERE arthritic pain…Cancer Therapy…”
           
ANANACUR ™
  • “[M]ost effective natural Anti-inflammatory…Health Benefits:…Anti-inflammatory …Upper Respiratory Infections…Spasmolytic…Gall Stones…Scleroderma & Psoriasis…”
  • “[I]leitis, Diverticulitis…Gastric, duodenal ulcers.  Circulatory diseases…Potentiation of antibiotics...Arthritis(rheum., osteo.)…Migrains (sic), Bronchial asthma…SEVERE arthritic pain…Cancer Therapy…”
 
CURLONGA ™
  • Health Benefits:…Anti-Inflammatory...Gall Stones…Hypercholersterolemia …Anticholesterolemic…”
 
HYDROXO-12 ™
  • “Health Benefits:…Osteoporosis…Asthma…Alcoholism…”
 
K-QUINONE ™
  • “Health Benefits:…Clotting Disorders…Anti-inflammatory...”
  • “Warfarin therapy has been shown to induce vascular calcification…Vitamin K enables these proteins to bind to calcium ions and platelet derived phospholipids in the clotting process…An ever-increasing list of drugs and supplements is being shown to lower vitamin K dependent protein levels…analgesics, antibiotics, anticoagulants, anticonvulsants, Vitamin E…”
 
MAXIFLAV ™
  • “Health Benefits:…Allergies…Asthma…Gout…Psoriasis…Idiopathic Thrombocytopenic Purpura…Chronic Statis Ulcers…Eczema…”
 
PEPLIC ™
  • Health Benefits:…Gastritis…Esophagitis…Duodenal Ulcers…Gastric Ulcers…”
 
ZINC-PLUS ™
  • Health Benefits…Infections/Wounds… Alopecia…Bone loss…Chronic Fatigue…”
 
CRATOXY ™
  • “Health Benefits…Hypertension…Angina….Osteoarthritis…”
NatexHIP ™
  • “Health Benefits…Direct anti-viral activity)…Lowers cholesterol and reduces platelet aggregation…DECREASES INFLAMMATION…DECREASES CANCER RISK…” 
NatexROOT ™
  • “Health Benefits…Anti-inflammatory…Anti-bacterial (Staph)…”
beta-PLEX™
  • “Health Benefits…Inflammation…”
 
Cystaseptic ™
  • “Health Benefits…Urinary Tract Infections with Tri-Quench…”
 
Echinacea
  • Health Benefits…UTI’s…Yeast Infections…Strep Throat…”
 
Tri-Quench™
  • “Iodide – One Mineral Can Help A Myriad Of Conditions From Atheroslerosis To “COPD”…kept infection away as well as any "modern" antibiotic ointment…potassium iodide (usually abbreviated by it’s (sic) Latin initials “SSKI”)…prevent any "airline sinusitis" or other respiratory infection…it inhibits or kills bacteria, viruses, and fungi before they can cause an infection…bladder infection…iodine (a close “relative” off?? SSKI) would eliminate even the most severe cases of fibrocystic breast disease…helped ovarian cysts disappear within two to three months with the same quantity of SSKI…"Dupuytren's contracture" and "Peyronie's disease" are two "fibrotic" conditions that can be helped considerably by SSKI…a combination tablet called "Iodo-niacin" (iodide 120 milligrams, niacin 15 milligrams) taken for several months could actually reverse atherosclerotic clogging of arteries…recommend 4 to 6 drops of SSKI and niacin-containing B-complex daily (along with many other things) for anyone with significant cholesterol-related atherosclerotic clogging…If you have chronic bronchitis and or emphysema ("COPD", "COLD") SSKI is an invaluable tool…With regular SSKI use, bronchial infection is a much less frequent happening…”
 
Licrogel
  • “[I]nhibits the growth of several unrelated DNA and RNA viruses including Herpes Simplex Types I and II, Vaccinia, Polio, and SARS-Coronavirus…”
  •  “[A]active ingredients in LICROGEL reduce both frequency and severity of herpetic outbreaks…LICROGEL may be used for both oral and genital herpes…”
  • “[B]eneficial for Herpes Zoster lesions and prevention of post herpetic neuralgias...”
           
PANTEX
  • “[I]s intended for...ECZAMATIOUS RASHES…NEURODERMATITIS… ALOPACIA AREATA…ATOPIC DERMATITIS...”
  • “[I]s indicated in any condition where topical steroids are providing relief but there is concern about side effects…”
 
AMPEX
  • “Health Benefits:…Psoriasis…”
 
DOXIGEL
  • “Health Benefits:… Seborrheic dermatitis...”
 
Folirinse™
  • “[I]s readily absorbed as a anti-gingivitis mouth wash and rinse…”
           
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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. §355(a)]; see also section 301(d) of the Act [21 U.S.C. §331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your “ANANABROM™,” “ANANACUR™,” “CURLONGA™,” “HYDROXO-12™,” “K-QUINONE™,” “MAXIFLAV™,” “PEPLIC™,” “ZINC-PLUS™,”  “CRATOXY™,” “CYSTASEPTIC™,” “ECHINACEA,” “TRI-QUENCH™,” “Licrogel,” and “PANTEX” products are offered for conditions that are not amenable to self-diagnosis  and treatment by individuals who are not medical practitioners; therefore,adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of theAct, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbrandeddrug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. §331(a)].
 
Adulterated Dietary Supplements
 
Even if your “ANANABROMTM,” “ANANACURTM,” “CURLONGATM,” “HYDROXO-12TM,” “K-QUINONETM,” “MAXIFLAVTM,” “PEPLICTM,” “ZINC-PLUSTM,” “CRATOXYTM,” “NatexHIPTM,” “NatexROOTTM,” “beta-PLEXTM,” “CystasepticTM,” “Echinacea,” “Tri-QuenchTM,” products did not have therapeutic claims, which make them drugs, these products and all dietary supplement products that you manufacture would still be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).  
 
Specifically, during our inspection, our investigators observed the following violations, which were noted on form FDA 483, Inspectional Observations, issued to you on May 19, 2014. We received your written response dated June 2, 2014, to the Form FDA 483. 
 
Our inspection revealed the following violations:
 
1.    You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm manufactures dietary supplements; however, you stated during the inspection that you do not perform any identity testing for your dietary ingredients, and that you rely on your vendor’s certificate of analysis to ensure identity. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of the dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements of 21 CFR 111.75(a)(1)(ii), and FDA has granted such a petition. Your firm has not petitioned FDA for such an exemption.
 
We have reviewed your response letter, dated June 2, 2014, and have determined that your response is inadequate. You state in your response letter that "All raw materials are confirmed with a Certificate of Analysis provided by their manufacturers." As stated above, you must conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(l)(i). A Certificate of Analysis may not be used in lieu of an identity test.
 
2.    You failed to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70(a). Specifically, you stated during the inspection that you do not have established specifications for your components [21 CFR 111.70(b)], in-process materials [21 CFR 111.70(c)], finished products [21 CFR 111.70(e)], and labeling and packaging components [21 CFR 111.70(g)].
 
We have reviewed your response letter, dated June 2, 2014, and have determined that your response cannot be evaluated because of lack of supporting documentation. You state in your response letter that "Again, we do in fact have multiple check points during production to ensure product parameters. Likewise, no written protocol was provided at time of inspection." However, you have not provided us with documentation of specifications that you have established for any point, step, or stage in the manufacturing process where control is necessary to ensure product quality. We therefore cannot determine whether such "check points" are adequate.
 
3.    You failed to collect any representative samples from each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet specifications, as required by 21 CFR 111.80(a). You stated to our investigator during our inspection of your facility that representative samples are not being collected. 
 
We have reviewed your response letter, dated June 2, 2014, and we have determined that your response cannot be evaluated because of lack of supporting documentation. You state in your response letter that "We will begin systematic sampling as required." However, you did not provide us with a description of your sampling plan. We, therefore, could not determine the adequacy of your sampling plans. 
 
4.    You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that are distributed, as required by 21 CFR 111.83(a). You stated to our investigator during our inspection of your facility that reserve samples are not being collected. 
 
We have reviewed your response letter, dated June 2, 2014, and have determined that your response cannot be evaluated because of lack of documentation. You state in your response letter that "We will begin systematic sampling as required." However, you did not provide us with a description of your sampling plan. You also state "We have established SOPs for every aspect of manufacturing, quality control, etc.," but you did not provide us with a copy of the established SOPs. We, therefore, could not determine the adequacy of your SOPs.
 
5.    You failed to identify personnel to be responsible for your quality control operations, as required by 21 CFR 111.12(b). Furthermore, you failed to establish and follow written procedures for the responsibility of quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). Your firm’s quality control person must approve for release, or reject any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h). The quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)). However, you stated to our investigator during the inspection of your facility that you do not have established written quality control procedures. 
 
We acknowledge your response, dated June 2, 2014, to the Form FDA 483, Inspectional Observations, issued at the close of the inspection. In your response letter, you state “We have established SOPs for every aspect of manufacturing, quality control, etc. We do have written protocol information, but once again I do not believe an example of such was provided at the time of inspection.” We cannot evaluate the adequacy of your response because you failed to provide documentation to support your statements regarding the quality control-related violations identified. 
 
6.    You have not prepared or followed a written master manufacturing record (MMR) for each unique formulation of dietary supplement you manufacture, as required by 21 CFR 111.205(a). You stated to our investigator during our inspection of your facility that the only documents used in the manufacture of your dietary supplements are batch production records (BPR) which list the Code #, date made, Batch number, “Exp” date and Stock # for products such as “beta-Plex™,” “Crotoxy™,” and “Peplic™.” 
 
We acknowledge your response, dated June 2, 2014, to the Form FDA 483, Inspectional Observations, issued at the close of the inspection. We cannot evaluate the adequacy of your response because you failed to provide any documentation. You state in your response that you keep an MMR. However, you did not provide a copy of the MMR for our review.
 
7.    Your batch production records (BPR) do not contain complete information related to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260.  Specifically, the BPRs for “Hydroxy-12,” all lots, did not include the following information:
 
a)    The identity of the equipment used in producing the batch [21 CFR 111.260(b)].
b)    The date and time of maintenance, cleaning, and sanitizing the equipment and processing lines used in batch production [21 CFR 111.260(c)].
c)    The identity and weight or measure of each component used [21 CFR 111.260(e)].
d)    A statement of actual yield and a statement of percentage of theoretical yield, and actual results obtained during any monitoring operation [21 CFR 111.260(f)].
e)    The results of any testing or examination performed during batch production [21 CFR 111.260(h)].
f)    Documentation that your finished dietary supplement products meet specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(j)].
 
We have reviewed your response letter, dated June 2, 2014, and cannot evaluate the response because you did not directly address your failure to include in your batch production record complete information regarding the production and control of each batch, and you did not include documentation that would allow us to evaluate your response. You state in your response letter that "We will begin systematic sampling as required." However, you did not provide us with a description of your sampling plan. You also state "We have established SOPs for every aspect of manufacturing, quality control, etc. ," but you did not provide us with a copy of the established SOPs. We, therefore, could not determine the adequacy of these SOPs.
 
Misbranded Dietary Supplements
 
Even if  your “ANANABROMTM,” “ANANACURTM,” “HYDROXO-12TM,” “CYSTASEPTICTM,” “ECHINACEA,” “MAXIFLAVTM,” “PEPLICTM,” “CRATOXYTM,” “NatexHIPTM,” and “NatexRootTM”  products were not unapproved new drugs, they would still be misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343]. The inspection revealed the following violations of labeling requirements for dietary supplements:
 
1.    Your “ANANABROMTM,” “ANANACURTM,” and “NatexHIPTM” products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] in that their labels fail to identify the part of the plant from which an ingredient is derived in the ingredient statement or in the nutrition label as required by 21 CFR 101.36(d)(1). 
 
2.    Your “ANANABROMTM,” “ANANACURTM,” “HYDROXO-12TM,” “MAXIFLAVTM,” “PEPLICTM,” “CRATOXYTM,” “NatexHIPTM,” “beta-PLEXTM,” and “TRI-QUENCHTM” products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that their labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement.
 
3.    Your “ANANABROMTM,” “ANANACURTM,” and “MAXIFLAVTM” products are misbranded within the meaning of section 403(i)(2) of the Act [21 US.C.§ 343(i)(2)] because their labels fail to declare each ingredient as required by 21 CFR 101.4 (a) and 21 CFR 101.4 (g). For example the herbal supplements are encapsulated in gelatin capsules. The label fails to declare all the capsule ingredients.
 
4.    Your “beta-PLEXTM” and “HYDROXO-12TM” products are misbranded within the meaning of Section 403(q) (l)(A) of the Act [21 US.C.§ 343(q)(1)(A)]because the serving size declared on the label is incorrect. The suggested use for “beta-PLEXTM” states 1-3 drops daily; therefore, the serving size should be 3 drops. The suggested use for “HYDROXO-12TM” states 2 drops daily; therefore, the serving size should be 2 drops. 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.
 
5.    Your “TRI-QUENCHTM” and “beta-PLEXTM” products are misbranded within the meaning of Section 403(a)(l) of the Act [21 U.S.C.§ 343(a)(1)] and as defined in 21 CFR 101.36(b)(1)(i) and 101.9(b)(8) in that the established servings per container presented on the labeling is incorrect; therefore, rendering the label content with respect to servings per container false or misleading. Specifically, “TRI-QUENCH” states servings per container to be approximately 1250 servings; however, based on a 1 drop serving size and a container size of 30mL the servings per container should be approximately 600. “beta-PLEXTM” states servings per container to be approximately 850 servings; however, based on a 3 drop serving size and a container size of 30mL the servings per container should be approximately 200.
 
(b)(3)(B)
 
This letter is not an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for all of your products to ensure that the claims you make for your products do not cause them to violate the Act.
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice.  The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products.
 
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
We request that you notify this office in writing, within fifteen working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
 
Please send your reply to the Food and Drug Administration, Attention: LCDR Cynthia White, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have questions regarding any issue in this letter, please contact LCDR White at (425) 302-0422.
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
cc: 
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560