Inspections, Compliance, Enforcement, and Criminal Investigations

Star Health & Beauty LLC 5/26/17

 

  

Black HHS-Blue FDA Logo

 

 

 
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309 

 

May 26, 2017
 
 
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
 
 
Mr. James W. Dukes, Chief Executive Officer (CEO)
Star Health & Beauty LLC
14500 Lochridge Blvd Ste E
Covington, GA 30014-4941
 
WARNING LETTER
(17-ATL-08)
 
 
Dear Mr. Dukes:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address, www.s-h-b.com in May 2017 and determined that you take orders there for the products Nu Essentials Royal Jelly Capsules, NuMan Male Enhancement Capsules, Star’s Male Potency Tonic, Sculpting Crème, Royal Touch – Anti-Wrinkle Serum, Realyze Under Eye Seryum, proEASE Wild Yam Cream, ProK Professional Strength Vitamin K Cream, proDHEA™ Transdermal DHEA Cream, Professional Formulas Natural Analgesic Cream, proGen Anti-Aging Natural Growth Hormone Precursor Cream, ProPhytogen Cream, Sensual Lips, Sun Warrior Ginsing Moisturizer™, NuGen HP, She Max HP, and V Max HP. The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 201(g)(1)(C)] in that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
 
FDA also inspected your drug, dietary supplement and cosmetic products manufacturing facility, Star Health & Beauty LLC, at Covington, GA, from October 17 to 26, 2016. Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products 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 found under 21 CFR Part 111. 
 
In addition, our investigators identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.”
 
At the conclusion of the inspection, you were issued a Form FDA 483 detailing our investigator’s observations during the inspection. We did not receive a letter with your response to the observations.
 
Unapproved New Drugs
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
 
Nu Essentials Royal Jelly Capsules
 
o   “Royal Jelly helps your body protect itself from viruses and can aide in preventing colds and infections...”
o   “[I]mmune protection…fights against bacteria…antidepressive…”
 
NuMan Male Enhancement Capsules
 
o    “[M]uira Puama is one of the best herbs to use for erectile dysfunction…”
 
Star’s Male Potency Tonic
 
o   “[U]sed as a remedy for impotence…”
o   “[B]eneficial for prostate enlargement and infections.”
 
Sculpting Crème
 
o   “Sculpting Crème eliminates and prevents the accumulation of fats and wastes that become trapped in the susceptible cells just below the skin.”
o   “[S]timulates microcirculation to help your body reduce fat deposits.”
 
Royal Touch – Anti-Wrinkle Serum
 
o   “Natural Botox Alternative”
o   “[S]timulate collagen growth…reduction of deep wrinkles…”
o   “[P]revent aging of the skin …”
o   “Emu Oil contains…healing properties…known to repair skin damage.”
 
Realyze Under Eye Seryum
 
o   “Suppresses inflammatory enzymes, decreasing puffiness and swelling”
o   “Strengthens capillaries, arteries and veins…”
o   “It promotes collagen formation, thereby increasing capillary blood circulation, retards capillary leakage, reduces melanin production…to reduce swelling…”
o   “Vitamin K…stimulates Epithelial growth…”
o   “Vitamin C – Helps to protect against damaging UVA/UVB rays…and stimulates collagen production...”
o   “Hexapeptide 3… reduces wrinkles… Also has been shown to prevent aging of the skin...”
o   “Marine Collagen…helping cells to renew themselves… “
o   “Emu Oil - … Vitamin E: anti-oxidant and healing agent….”
o   “Vitamin E…healing agent, Vitamin A…skin repairer, Terpines: an antiseptic…”
 
proEASE Wild Yam Cream
 
o   “Women…their first choice in addressing PMS and other hormone related issues.”
o   “Users experience less PMS symptoms, reduced stress and increased vitality.”
o   “To relieve cramping… apply the cream to the abdomen each half hour until the cramping subsides.”
o   “With hot flashes…apply…cream each time they have a hot flash.”
 
ProK Professional Strength Vitamin K Cream
 
o   “[S]timulates epithelial growth and promotes…clarification of the damaged skin.”
o   “Helps eliminates (sic) spider veins (dilated or broken capillaries) and bruising…”
o   “[C]osmetic surgeons…use it for pre & post operative treatment to reduce post operative bruising, swelling, and to speed up the healing process and diminish scarring.”
o   “[C]lots the blood…”
 
proDHEA™ Transdermal DHEA Cream
 
o   “Boost Immune Function”
o   “Increase Lean Muscle Mass”
o   “Reduce Body Fat”
o   “Reduce Stress”
o   “Combat Depression”
o   “Enhance Sexual Drive & Desire”
o   “Improve Memory”
o   “Helps Prevent Osteoporosis & Cardiovascular Disease”
o   “[I]ncrease estrogen and testosterone levels… increase IGF-1, increase lean body mass, and decrease appetite.”
o   “[I]mprove quality of sleep, decrease joint pain…”
 
Professional Formulas Natural Analgesic Cream
 
o   “[L]ower blood pressure.”
o    “[I]ncreasing the blood supply, it reduces inflammation.”
o    “[A]nti-inflammatory properties.”
o   “[H]ighly effective in treating rheumatoid arthritis.”
 
proGen Anti-Aging Natural Growth Hormone Precursor Cream
 
o   “[A]cts as a precursor which may induce the pituitary to increase production of the bodies (sic) own natural HGH.”
o   “[M]ay assist in slowing down and even reversing the… aging process.”
o   “HGH is one of many endocrine hormones…”
o   “Not only does it suppress biological aging…”
o   “HGh affects almost every cell in the body…”
o   “[S]trong anti-phlogiston (inflammation reducing) effect.”
o   “[V]ery powerful anti-inflammatory… more effective than aspirin in reducing inflammation and pain.”
o   “[T]reat swelling, inflammations, and sprains.”
o   “[R]elieve pain …”
o   “[R]educe inflammation …”
o   “[R]elieved stiffness…”
o   “It’s (sic) medicinal values include anti-inflammatory, antiseptic, carminative, antispasmodic and sedative as well as promoting wound healing.”
o   “HGH has been found to reverse and/or slow down the aging process by:
§ Restoring Muscle Mass
§ Decreasing Body Fat
§ Thickening of the skin
§ Improving cholesterol profile
§ Increasing sexual function
§ Improving Memory
§ Elevating Mood
§ Normalizing blood pressure
§ Increasing cardiac output and stamina
§ Improving Immune Function
§ Restoring lost hair growth
§ Restoring size of organs that shrink with age
§ Improving Sleep
§ Increasing Energy”
 
ProPhytogen Cream
 
o   “[C]ontains phyto-hormones thatare identical to the human estrogens estradiol, estriol, and estrone…”
o   “It has a stabilizing effect on the entire endocrine system, calming hot flashes and night sweats, and restoring normal sleep patterns…”
o   “[E]xhibits dh-Testosterone blocking qualities to help reduce … facial hair growth.”
o   “Black Cohosh Known….To restore healthy menstrual activity.”
o   “Stimulates estrogen, cortisone and aldosterone production…”
o   “Assists with menopausal symptoms, helps to regulate menstruation and PMS.”
o   “Helps liver problems, heart palpitations, high blood pressure, hypoglycemia and chronic bronchitis.”
o   “Used to dissolve blood clots, strengthen the central nervous system and nourish the brain.”
o   “[I]s helpful for hormonal balancing, PMS, weight control…”
 
Sensual Lips
 
o   “[S]timulates fat cells below lip tissue increasing the size of your lips.”
o   “[E]xpand the cellular substructure of your lips...”
 
Sun Warrior Ginsing Moisturizer™
 
o   “[P]rovide healing…benefits to the skin…”
o   “[K]nown to protect again (sic) infections with its antibacterial and antiviral properties.”
o   “[A]ssist the body’s ability to utilize oxygen on a cellular level.”
 
NuGen HP
 
o   “Fuller Thicker Hair In As Little As Two Months”
o   “[A] natural alternative to combat hair loss…”
o   “Restore thinning hair with visible results”
o   “[R]estores and maintains healthy hair.”
o    “[P]roven to prevent DHT…from attaching to the hair follicle...”
o   “[W]orks to balance the hormones in the follicle…”
o   “[T]o restore thickness and prevent more hair from falling out.”
o   “Nugen HP – The All-Natural Hair Restoration System?
o   “[R]evitalizes your hair follicles stimulating fuller, thicker hair.”
 
She Max HP
  • “She-Max HP contains natural herbs that have been proven to have the following actions: antibacterial, anti-depressant, anti-fatigue, aphrodisiac, improves: endurance, mental performance, physical performance, works as a urogenital tonic and uterine stimulant. Improves and maximizes ability to achieve orgasmic pleasure.”
  • “SHE-MAX stimulates sexual energy by expanding the blood vessels causing increased blood flow to the genital area causing increased sexual stimulation and sensation.”
  • “SHE-MAX HP contains the most essential active ingredients scientifically proven to enhance neurotransmission and blood flow in regions of the brain and genital organs that control sensation and sexual function!”
V Max HP
  • “VMAX HPTM is helping men of all ages . . . overcome erectile dysfunction naturally!”
  • “VMAX HP stimulates sexual energy by expanding the blood vessels causing increased blood flow to the penis.”
  • “ . . . contains three active ingredients to help your body produce the proper blood flow to the penis.”
  • “To further enhance the erection process, VMAX HPTM contains the extract of the herb Ginko Biloba, which recently has been heavily documented for its ability to relax the body’s arteries and improve blood flow.”
  • “VEP Protein . . . is a powerful vasodilator that further helps open flood vessels and increase circulation to the penis.”
  • “Erectile Dysfunction”
  • Section entitled “Erectile Dysfunction Facts”
  • “Results have shown over 80% success rate in treating Erectile Dysfunction.”
  • “I would like to share my clinical experience with using VMAX topical lotion for the treatment of erectile dysfunction . . . a valuable adjunct in treating the condition of erectile dysfunction; by increasing vascular flow to the penis and increasing the production of nitric oxide.”
  • “I am 48 and experienced ED for the first time a few months ago . . . that is when I began using VMAX HP –it works the same [as Viagra] without the side effects.”
Your Nu Essentials Royal Jelly Capsules, NuMan Male Enhancement Capsules, Star’s Male Potency Tonic, Sculpting Crème, Royal Touch – Anti-Wrinkle Serum, Realyze Under Eye Seryum, proEASE Wild Yam Cream, ProK Professional Strength Vitamin K Cream, proDHEA™ Transdermal DHEA Cream, Professional Formulas Natural Analgesic Cream, proGen Anti-Aging Natural Growth Hormone Precursor Cream, ProPhytogen Cream, Sensual Lips, Sun Warrior Ginsing Moisturizer™, NuGen HP, She Max HP, and V Max HP 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 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 Nu Essentials Royal Jelly Capsules, NuMan Male Enhancement Capsules and Star’s Male Potency Tonic 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 Nu Essentials Royal Jelly Capsules, NuMan Male Enhancement Capsules and Star’s Male Potency Tonic products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
Adulterated Dietary Supplements
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to 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 which do not meet the CGMP regulations for dietary supplements in 21, Code of Federal Regulations, Part 111.
 
Our investigators observed specific violations, including, but not limited to, the following:
 
1.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Specifically, you stated that you had not established written quality control procedures during the inspection.
 
Additionally, once you have established your written procedure for quality control you must implement quality control operations into your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65.
 
2.    You failed to prepare a written master manufacturing record 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).
 
Specifically, you stated that you have not established master manufacturing records for any of your dietary supplement products and that you provide your staff with verbal production instructions and do not prepare written master manufacturing records for your dietary supplement products.
 
3.    You also failed to prepare a batch production record every time you manufactured a batch of a dietary supplement as required by 21 CFR 111.255(a).
 
Specifically, you told our investigator that your firm does not establish batch production records for the majority of your dietary supplement products.
 
4.    You failed to establish specifications for 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 master manufacturing record, as required by 21 CFR 111.70. Specifically,
 
a.  You failed to establish specifications for each component that you use in the manufacture of a dietary supplement. Specifically, you failed to establish the following: an identity specification; specifications to ensure purity, strength and composition of dietary supplements manufactured using the components are met; and specifications that establish the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(1)-(3).
 
Once you have established component specifications and before using a component, you must 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), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing, and you must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2).
 
b.  You failed to establish specifications for dietary supplement labels (labeling specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d).
 
c.  You failed to establish specification for each dietary supplement that you manufacture, specifications 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 that may lead to 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).
 
Once you have established the above specifications, you must determine whether the specifications have been met as required by 21 CFR 111.75(c). We also note that you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
 
d.  You failed to establish specifications that provide sufficient assurance that the product you receive from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).
 
e.  You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).
 
Adulterated Drugs
 
In addition, our investigators identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.”
 
Our investigators observed specific violations, including, but not limited to, the following.
 
1.    Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products (21 CFR 211.22(a)).
 
Your firm lacks a quality control unit and any documentation of quality control review or approval of any of the firm's procedures or operations.
 
In response to this letter, provide your corrective actions to ensure that you establish a quality control unit with the responsibilities and authorities specified above.
 
2.    Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
 
You released finished drug products without testing your drug products to determine if they conformed to specifications.
 
In response to this letter, describe your corrective action plan to ensure that your drug products are tested before release.
 
3.    Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
 
Your firm has not validated the manufacturing processes for each of your drug products. Documented, successful process validation shows that each step of a manufacturing process is controlled and provides confidence that finished drug products meet all quality attributes, including specifications.
 
See FDA’s guidance document, Process Validation: General Principles and Practices, for FDA's current thinking on elements of process validation at http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf
 
In response to this letter, provide your complete process validation plan and specify the dates by which you expect to complete validation for each of your drug products. Also include the interim steps you will take to ensure the quality of your drug products prior to completing your validation activities.
 
4.    Your firm failed to ensure that your drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).
 
You have not established a written testing program to assess the stability characteristics of the drug products you manufacture. You do not have any data to support the two-year expiration date you assigned to all your drug products.
 
In response to this letter, provide a copy of your stability testing procedures of your drug products. For each product, specify the stability-indicating methods and acceptance criteria you will rely on for each test to support the labeled storage conditions and expiry dates for your drug products.
 
5.    Your firm failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a)). Your firm also failed to prepare batch production and control records for each batch of drug product produced that include an accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed (21 CFR 211.188(a)).
 
You do not have master production and control records for any of your drug products. Furthermore, you do not prepare batch production and control records for any of your drug products. Instead you provide verbal manufacturing instructions to your staff.
 
In response to this letter, provide a copy of your master production and control records for each of your drug products to assure the uniformity of your drug products from batch to batch. Also provide a copy of one executed batch production and control record for each of your drug products.
 
6.    Your firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192 (21 CFR 211.198).
 
You have not established procedures to handle complaints for any of your drug products.
 
In response to this letter, provide a copy of your written procedures to handle all complaints about your drug products.
 
Misbranded Dietary Supplements
 
Additionally, your dietary supplement products are misbranded under Section 403 of the Act [21 U.S.C. § 343], in that they fail to comply with the labeling requirements for dietary supplements. Your label violations include the following:
 
1.    Your Contour Too Breast Enhancing Capsules, ProPhytogen Plus, and NuMan Male Enhancement Capsule products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the product labels fail to identify the products using the term “dietary supplement”, as required by 21 CFR 101.3(g).
 
2.    Your Contour Too Breast Enhancing Capsules, Bentonite Magma, ProPhytogen Plus, and NuMan Male Enhancement Capsule products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail 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. “Domestic address or domestic phone number” means a complete address or phone number. The labels for these products do not include complete addresses or phone numbers.
 
3.    Your Liu Jun Zi Tang product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains the product name in a foreign language, but does not repeat all the required information in both English and the foreign language. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
 
4.    Your Clear Spiro, Contour Too Breast Enhancing Capsules, and Liu Jun Zi Tang products are misbranded within the meaning of section 403(r)(6)(C) of the Act [21 U.S.C. §343(r)(6)(C)] because the labels bear structure/function claims but fails to bear the required FDA dietary supplement disclaimer as required by, 21 CFR 101.93(c). Under section 403(r)(6) of the Act, a dietary supplement may bear certain claims, generally called "structure/function claims," on its label or in its labeling provided that the firm has substantiation that the claim is truthful and not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim; and the claim includes a mandatory disclaimer.
 
5.    Your NuMan Male Enhancement Capsule, Clear Spiro, and Liu Jun Zi Tang 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 the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. For example, “Horny Goat Weed”, “Que Bracho”, “White Atractylodes”, “Ledebouriella”, and “Morus” are not standardized common names as noted in Herbs of Commerce. The Latin binomial name of a botanical is required when the botanical lacks a standardized common name.
 
Conclusion
 
The violations cited in this letter are not meant to be an all-inclusive statement of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all your products comply with the Act and its implementing regulations.  
 
We offer you the following dietary supplement labeling comments:
 
o    Your Bentonite Magma product label bears the statement “Percent Daily Values are based on 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).
 
o    Your Bentonite Magma product label places the (b)(2)-dietary ingredients in an incorrect order which does not follow the order provided under 21 CFR 101.36(b)(2).
 
o    Your Clear Spiro and Liu Jun Zi Tang products list dietary ingredients in the Supplement Facts labels along with additional text that is a further description of the dietary ingredient but in Latin terms. We note that the Latin binomial name of a botanical may be listed in parentheses following the standardized common name of a botanical consistent in accordance with 21 CFR 101.4.
 
o    Your ProPhytogen Plus and Bentonite Magma product labels do not follow the format requirements under 21 CFR 101.36(e), such as the requirements for heavy bar placement.
 
You should take prompt action to correct the violations cited in this letter and prevent their future recurrence. Failure to promptly correct these violations may result in legal 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].
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for the delay and the date by which the corrections will be completed.
 
Please direct your response to my attention at the address above. If you have any questions about the content of this letter you may contact Janice L. King, Compliance Officer, at 843-746-2990, X16 or by email at Janice.king@fda.hhs.gov.
 
Sincerely,
/S/ 
Ingrid A. Zambrana
District Director
U.S. Food & Drug Adminisration
FDA Atlanta District
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
Office of Regulatory Affairs
 

 

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