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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sunset Natural Products Inc. 3/19/13

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770 

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
FLA-13-14
March 19, 2013
 
Ms. Teresa Martinez-Arroyo
President
Sunset Natural Products Inc.
7345 SW 45 St.
Miami, FL 33155
 
Dear Ms. Martinez-Arroyo:
 
Between August 31 and September 11, 2012, the U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 7345 SW 45 St., Miami, FL. The inspection revealed violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations cause the dietary supplement products manufactured and packaged at your facility to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (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 CGMP regulations for dietary supplements. 
 
In addition, we have reviewed the labeling of your products, including your website located at the internet address www.sunsetnaturallab.com in January 2013, and determined that the products Hongofin Anti-Fungus Spray w/Aloe Vera, Hongafin (pinceladas), Hongafin Anti-Fungus Powder, Fungus Control Formula by IDLS, Body Anti-Fungal Cream, Shampoo, Melatonin, Selenium, Omega 3, Spirulina, Alfalfa, Aloe Vera, Cat’s Claw, Circulation, Garlic, Healthy Male Prostate, Echinacea, Saw Pallmetto, St. John’s Wort Extract, DHEA, and Sugar Burner are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your product labels and website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
 
Further, even if your Fungus Control Formula by IDLS product did not have a therapeutic claim, it is misbranded under section 403 of the Act [21 U.S.C. § 343] because it does not comply with FDA’s labeling regulations under 21 CFR Part 101.
 
You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved Drugs
 
Examples of some of the claims observed on your product labels include:
 
Hongofin Anti-Fungus Spray w/ Aloe Vera
“Kills Athlete’s Foot fungus … Relieves Itching ∙ Burning …”
 
Hongofin (pinceladas)
“Control the Fungus under the nail … Relieves pain …”
 
Shampoo
“For Relief of: ∙ Dandruff ∙ Seborrheic Dermatitis ∙ Psoriasis … Active Ingredients: …”
 
Hongofin Anti-Fungus Powder
“Cure: ∙ Athlete’s Foot ∙ Jock Itch and ∙ Ringworm ∙ Itching ∙ Burning …”
 
Fungus Control Formula by IDLS 60 Caps
“Control fungus under the nails … Relieves Pain”
 
Examples of some of the claims observed on your web site include:
 
Melatonin
“Melatonin appears to keep some forms for cancer from spreading as rapidly as tumors that have not been treated …”
 
Selenium
“Selenium may protect against some forms of cancer ... Selenium … is believed to reduce … viral hepatitis …”
 
Omega 3
“[L]arge doses of fish oil may be effective for conditions and maladies including Parkinson's disease … bipolar disease, attention-deficit hyperactivity disorder, alcoholism … Alzheimer's disease, diabetes, and arthritis …”
 
Spirulina
“Spirulina plays a key role, lowering blood cholesterol levels …”
 
Alfalfa
“Also known in treating arthritis, diabetes, lowering cholesterol …”
 
Aloe Vera
“[A]n excellent component in healing of wounds … it helps prevent infections …”
 
Cat's Claw
“[T]he many therapeutic benefits is offers for relieving arthritis, allergies … ulcers, and a variety of gastrointestinal disorders … may help to reduce the occurrence of stroke and heart attack by lowering blood pressure … and controlling cholesterol levels … treatments for Crohn's disease, gastric ulcers and tumors, parasites, colitis, gastritis, diverticulitis, and leaky bowel syndrome …”
 
Circulation
“…relieving fluid congestion in the legs and minimizing the occurrence of damaged or weakened vessles that obstruct proper circulation. Continued use may improve hemorrhoid[s] …”
 
Garlic
“[T]o prevent … atherosclerosis, high blood pressure, flu, colds, coughs, bronchitis, gastrointestinal problems, … Studies have shown that garlic can kill many types of bacteria, some viruses, a number of fungal infections, and in some cases even intestinal parasites …may even help prevent certain cancers such as colon cancer.”
 
Healthy Male Prostate
“Prevent the occurrence of BPH … Reduce pain and burning during urination. Reduce swollen prostate glands …”
 
Echinacea
“Echinacea, is used to treat flu, fevers, coughs and colds, bronchitis, urinary tract infections, wounds and burns, and inflammation of the mouth and pharynx. It is also used to prevent infection …”
 
Saw Pallmetto
“Saw palmetto has been used to treat the symptoms of benign prostatic hypertrophy (BPH) ...also used for other conditions, including chronic pelvic pain, bladder disorders…”
 
St. John's Wort Extract
“Best known for use as a mild antidepressant. Benefits in people with depression who take psychotropic drugs…Relieves mild to moderate depression…Fights retroviruses …”
 
DHEA
“DHEA has shown effectiveness when used in connection with systemic lupus erythematosus …”
 
Sugar Burner
“[N]atural supplement formulated to correct the effects of diabetes. It also helps to lower blood glucose levels …”
 
Sunset Natural Products Hongofin Anti-Fungus Spray w/ Aloe Vera, Hongofin (pinceladas), and Hongofin Anti-Fungus Powder are covered under the Final OTC Monograph for Topical Antifungal Drug Products (21 CFR Part 333 subpart C). Sunset Natural Products Shampoo is subject to the Final Monograph: Miscellaneous External Drug Products for Over-the-Counter Human Use: Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products (21 CFR Part 358 subpart H). However these products are not in conformance with their respective monographs. These products, as well as the other products identified above, are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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, because your Melatonin, Selenium, Omega-3, Spirulina, Alfalfa, Cat’s Claw, Garlic, Healthy Male Prostate, Echinacea, Saw Pallmetto, St. John’s Wort Extract, DHEA, and Sugar Burner products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, the labeling of these products fails to bear adequate directions for their intended uses, causing the products to be misbranded under section 502(f)(1)of the Act [21 U.S.C. § 352(f)(1)]. The introduction of these products into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
We note that all OTC drug products are subject to drug establishment registration, drug listing, and all existing drug labeling requirements described in section 502 of the Act [21 U.S.C. § 352] and in 21 CFR Part 201, including the “Drug Facts” labeling requirements under 21 CFR § 201.66.
 
Dietary Supplement CGMP Violations
 
Even if your products did not have these therapeutic claims which make them drugs, your dietary supplement products are adulterated based on the following significant violations:
 
  1. You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR § 111.75(a)(1)(i)nor has FDA received a petition from you, and granted the petition, to exempt you from this testing requirement, as required by 21 CFR § 111.75(a)(1)(ii).
 
Specifically, you could not provide any documentation to indicate you had verified the identity of the following dietary ingredients:
 
  •     Goldenseal Powder used in your finished product Fungus Control
a.   Lot #080612, dated 6/11/12
b.   Lot #220512 dated 5/9/12
c.   Lot # 390412 dated 4/17/12
 
  •     Milk thistle used in your finished product Hepasil B-Complex
a.   Lot #210812 dated 8/20/12
b.   Lot #410712 dated 7/25/12
c.   Lot #240712 dated 7/18/12
 
Furthermore, your SOP QC-100-00 entitled “Basic cGMP’s For Sunset Natural Products Personnel” document states that production materials are identified by the information on their labels, and that information on the identity of a finished product, component, raw material or sample should be taken directly from a label. A label review is not sufficient to verify the identity of a dietary ingredient.
 
We acknowledge receipt of your letter dated 10/2/12 and have determined that it is inadequate. Your SOP QC-108-00 entitled “Receiving Raw Material” states that the identity and quantity of raw materials are evaluated by counting and weighing the raw material and checking the label against the packaging list and purchase order, and that you ensure raw materials received include a Certificate of Analysis. If the raw material is a dietary ingredient, you must conduct identity testing; counting, weighing, comparing against a label or purchase order, and/or relying on a Certificate of Analysis are not sufficient to verify the identity of a raw material that is a dietary ingredient. We also note in your response that you state you have now established a relationship with a company called (b)(4) that samples your raw materials received, as well as your finished products. In reviewing the list of ingredients that were evaluated by (b)(4) for identity, it appears that neither milk thistle nor Goldenseal Powder were tested.
 
  1. You did not qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of the supplier’s tests or examinations, as required by 21 CFR § 111.75(a)(2)(ii)(A).
 
Specifically, you relied on supplier’s certificate of analysis (COA), but were unable to provide documentation for the qualification of your suppliers for the following components:
 
a.   Zinc oxide, Aloe Vera, Garlic, Hydrolyzed Beef Collagen, Lechler, Paba, Golden Seal, Echinacea, Magnesium Stearate, and Tabulose used in the manufacturing of Fungus Control lot numbers 080612, 22051, and 390412.
 
b.   Lecitina (as soy lecithin), Insitol, Sylimarin (as milk thistle ext. 80%), Vitamina B-1 (as thiamime), Vitamina B-2 (as riboflavine), Vitamina B-6 (as piridoxine HCL), Vitamina B-12 (as cyanocobalamine), Vitamina B-3 (as niacinamida), Carbonato de Calcio, Oxido de Magnesio, Colina (as choline bitartrate), and Microcrystalline Cellulose used in the manufacturing of Hepasil B-Complex lot numbers 210812, 410712, and 240712.
 
c.   DHEA, Microcrystalline Cellulose, and Magnesium Stearate used in the manufacturing of DHEA lot numbers 420812, 260612, and 190612.
 
Additionally, your Production Manager stated that you had not qualified component suppliers. 
 
We acknowledge receipt of your letter dated 10/2/12 and your SOP QC-114-00 entitled “Supplier Qualification Program.” We note that you state that you have now prepared, checked, approved and implemented this and your other SOPs. However, you did not submit any specific documentation of how you qualified your component suppliers and we are therefore unable to determine the adequacy of your response. We note that you must maintain documentation of how you qualified each supplier [21 CFR § 111.75(a)(2)(C)], and this information should be submitted in your response to this letter.
 
  1. You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required in 21 CFR §§ 111.205 and 111.210.
 
Specifically, you were unable to provide a MMR for the following dietary supplement batches:
 
  •     Fungus Control
a.   BATCH #080612, Manufactured on 6/6/12 (60,000 Capsules)
b.   BATCH #220512 Manufactured on 5/9/12 (15,000 Capsules)
c.   BATCH #390412 Manufactured on 4/17/12 (12,000 Capsules)
 
  •     Hepasil B-Complex
a.   BATCH #210812 Manufactured on 8/20/12 (450,000 Capsules)
b.   BATCH #410712 Manufactured on 7/24/12 (150,000 Capsules)
c.   BATCH #240712 Manufactured on 7/11/12 (400,000 Capsules)
 
  •     DHEA
a.   BATCH #420812 Manufactured on 8/31/12 (150,000 Capsules)
b.   BATCH #260612 Manufactured on 6/13/12 (250,000 Capsules) 
c.   BATCH #190612 Manufactured on 6/7/12 (350,000 Capsules)
 
Additionally, your Quality Assurance personnel stated that batch records are created by looking at a previous batch record and adjusting the amounts to create the desired batch size. Your Production Manager confirmed that MMRs were not established. 
 
We acknowledge receipt of your letter dated 10/2/12 and supporting documentation including your SOP QC-114-00 entitled “Master Production and Batch Production Issuence [sic].” We note that you refer to the Master Production Record form as attachment No. F-011; however, as you did not include a copy of this form, we are unable to determine the adequacy of your response.
 
  1. You failed to establish specifications for any point, step, 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 master manufacturing record, as required by 21 CFR § 111.70(a).
 
Specifically, you were unable to provide specifications for: 
 
  •     Fungus Control
a.   BATCH #080612 Manufactured on 6/6/12 (60,000 Capsules)
b.   BATCH #220512 Manufactured on 5/9/12 (15,000 Capsules)
c.   BATCH #390412 Manufactured on 4/17/12 (12,000 Capsules)
 
  •     Hepasil B-Complex
a.   BATCH #210812 Manufactured on 8/20/12 (450,000 Capsules)
b.   BATCH #410712 Manufactured on 7/24/12 (150,000 Capsules)
c.   BATCH #240712 Manufactured on 7/11/12 (400,000 Capsules)
 
  •     DHEA
a.   BATCH #420812 Manufactured on 8/31/12 (150,000 Capsules)
b.   BATCH #260612 Manufactured on 6/13/12 (250,000 Capsules) 
c.   BATCH #190612 Manufactured on 6/7/12 (350,000 Capsules)
 
In addition, your Production Manager and Quality Assurance personnel stated that you have not established specifications or conducted testing for your other dietary supplements.
 
Once you establish specifications, you must verify that specifications are met, in accordance with 21 CFR §§ 111.73 and 111.75.
 
We acknowledge receipt of your letter dated October 2, 2012; however, your response is inadequate because you did not submit any documentation to show that you have now established specifications or are verifying that specifications are met.
 
  1. Your firm failed to establish written procedures for the responsibilities of the quality control operations, as required by 21 CFR § 111.103. Furthermore, you failed to perform quality control operations in the manufacturing, packaging, labeling, and holding of your dietary supplements to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, in accordance with 21 CFR § 111.105.
 
Specifically, your quality control personnel failed to perform operations that include approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations that may affect the identity, purity, strength, or composition of a dietary supplement and reviewing and approving the documentation setting forth the basis for qualification of any supplier.
 
Misbranded Dietary Supplements
 
Even if the labeling for your Fungus Control Formula by IDLS product did not contain claims that cause it to be an unapproved new and misbranded drug, it would still be a misbranded dietary supplement under section 403 of the Act [21 U.S.C. § 343] in that the labeling does not comply with the food labeling requirements in 21 CFR Part 101, as follows:
 
Your Fungus Control Formula by IDLS product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2] because the product is a dietary supplement fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient, as required by 21 CFR § 101.4. Specifically,
 
  •   The label fails to declare garlic in the label, and it fails to list the part of the plant from which your dietary ingredient “sangre de grado [sic]” is derived in accordance with 21 CFR § 101.4(h).
  •   The label fails to list magnesium stearate and tabulose preceded by the word “Ingredients” in accordance with 21 CFR § 101.4(g).
 
Additionally your Fungus Control Formula by IDLS product is misbranded within the meaning of section 403(q)(5)(F) of the Act in that the label fails to bear nutrition labeling in the form of a “Supplement Facts” panel in accordance with 21 CFR § 101.36.
 
The violations mentioned above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
 
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover the FDA’s cost for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance 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. § 379j31 (a)(2)(B)). 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct the violations noted above. You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your written reply to the Food and Drug Administration, Attention: Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
                                                                       
Sincerely,
/S/
Emma R. Singleton
Director, Florida District