Inspections, Compliance, Enforcement, and Criminal Investigations

Brower Enterprises 9/9/13

  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

September 9, 2013 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                 
Refer to MIN 13 – 24
 
 
Stanley D. Brower
Barbara Brower
Co-Owners
Brower Enterprises
1002 E. Fifth Street
Canton, South Dakota 57013-1925
 
Dear Mr. and Mrs. Brower:
 
On December 4, 6, and 7, 2012, investigators from the Food and Drug Administration (FDA) conducted an inspection of your facility, Brower Enterprises, located at 1002 E. Fifth Street, Canton, South Dakota.  During the inspection we evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations, consistent with Title 21, Code of Federal Regulations, Part 111  (21 CFR 111). Our investigators found significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations, found in 21 CFR 111. These violations cause your products Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW 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.
 
Furthermore, during our inspection, FDA collected and reviewed labeling for several of the products you distribute, and we conducted a review of your websites www.browerent.com and www.myhealthent.com. Additional reviews of the websites were conducted in March and in May 2013. Based on our reviews, we have concluded that your Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW products are in violation of sections 403, 505(a), and 502(f)(1) of the Act, 21 U.S.C. §§ 343, 355(a), and 352(f)(1).
 
You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drug Violations:
 
We reviewed your websites www.browerent.com and www.myhealthent.com and we determined that you took orders there for your products Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW, which the websites promoted 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). Based on our reviews in March and in May 2013, we note that you have closed the website www.myhealthent.com. The disease claims on your websites and in your other promotional materials establish that your 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 claims that provide evidence that your products are intended for use as drugs include:
 
Myristoleate PLUS Cetyl Myristoleate (CMO):
 
  • In the newsletter BIO/TECH NEWS, which you use as promotional literature, on page 1: “If you have one or more of the following health problems … then this newsletter might very well be the most important newsletter you have ever received … Arthritis (Rheumatoid and Osteo) … Arteriosclerosis … Asthma, Autoimmune disorders … Cardiovascular disease, Crohn’s disease … Diabetes, Depression, Emphysema … Lupus … Leprosy … Scleroderma…. [R]ead on to find out more about the … substance which reports from the field suggest is already playing a major role in dramatically helping and even completely transforming … the lives of many people who have suffered with the above kinds of inflammatory problems[.]”
  • The same newsletter on page 2 quotes a physician as saying: CMO “is 98% effective against both Osteo- and Rheumatoid Arthritis. By ‘effective’ … I mean it will either cure the disease outright or at least leave the recipient greatly improved….” And later, “[W]hen Cetyl Myristoleate is used, ‘TMJ and carpal tunnel syndrome often are alleviated,’ he says.”
  • The same newsletter on page 4 quotes another physician as saying: “Over eighty-five percent of the thousands of people who’ve taken CMO have had a 70% to 100% improvement in joint mobility with corresponding reduction of pain and inflammation [associated with arthritis].”
  • On your website www.browerent.com: “Cetyl Myristoleate Plus … acts to regulate the immune system by ‘erasing the memory’ of T-cells in the body which have been mistakenly programmed to attack the joints, tissues, cartilage, and various organ systems.  Once this attack is halted, the body can begin its repair process without interference.”
 
Coral Calcium Formula:
 
  • On your website www.browerent.com: “Research links inappropriate calcium levels to … many degenerative diseases such as osteoporosis, allergies, gallstone disease, heart disease, cancer, and many more. ”
  • In your leaflet “Coral Calcium Formula” on page 1: “…Coral Calcium Formula delivers critical calcium…. [R]ecent research links appropriate calcium levels to … many degenerative diseases such as osteoporosis, allergies, gallstone disease, heart disease, cancer and more. Benefits: [c]alcium … resisting disease.”
 
Ultra Ellagic Plus Formula:
 
Your website www.browerent.com contains the following claims: 
 
  • “[E]llagic acid has been proven an effective anti-mutagen, anti carcinogen [sic], and inhibitor of cancer. Clinical tests conducted at the Hollings Cancer Institute at the Medical university [sic] of South Carolina (MUSC) show that ellagic acid … may be the most potent way to prevent cancer cells, inhibit the growth of cancer cells, and arrest the growth of cancer in persons with a genetic predisposition for the disease.”
  • “Ultra Ellagic acid is a phenolic compound that has become known as a potent anti-carcinogenic, anti-mutagenic compound.”
    “Ultra Ellagic Acid reduces the Incidence of Cancer.”
  • “HPV (human papilloma virus) exposed to ellagic acid from red raspberries experienced apoptosis (normal cell death).”
  • “Ellagic acid from red raspberries prevents destruction of the P53 gene by cancer cells. P53 is regarded as the safeguard of mutagenic activity in cervical cells. * Tests reveal similar results for breast, pancreas, esophageal, skin, colon, and prostate cancer cells. * Consuming one cup (150 mg) of red raspberries per day prevents the development of cancer cells.”
  • “[S]tudies suggest that one of the mechanisms by which ellagic acid inhibits mutagenesis and carcinogenesis si [sic] by forming adducts with DNA, thus masking binding sites to be occupied by the mutagen or carcinogen.”
  • “Research at the Hollings Cancer Center in Charleston, SC indicate [sic] that ellagic acid slows the growth of abnormal colon cells in humans, prevents the development of cells infected with human papilloma virus (HPV) which is linked to cervical cancer, and promotes apoptotic growth (natural death) of prostate cancer cells.  The apoptotic process triggered by this antioxidant also has beneficial effects on breast, lung, esophageal, and skin cancer (melanoma).”
  • “It also has anti-bacterial and anti-viral properties.”
  • “[E]llagic acid reduces the incidence of birth defects, promotes wound healing, reduces and reverses chemically induced liver fibrosis, and is helpful in the fight against heart disease.”
 
WOW:
 
Your brochure for this product contains the following claims; your website www.myhealthent.com also contains these claims:
 
  • “Guaisma (an ingredient in your product) … is commonly used for stomach pains, inflammations … dysentery, and diarrhea.   This herb was used for asthma, uterine pain, and hemorrhages….”
  • “Holm Oak (an ingredient in your product) … [a]nti-inflammatory and antibiotic properties.”
  • “Eastern Teaberry (an ingredient in your product) … [a]nti-inflammatory, antirheumatic [sic], antineuralgic [sic].” 
  • “Hemiangium Excelsum (an ingredient in your product) … is used for diarrhea and vomiting … [and] also used to kill lice and other parasites of man.  In the state of Morelos [it] is used for gastric problems, kidney problems and strokes.”
  • “Matarique (an ingredient in your product) … [i]s used primarily against diabetes, as well as for other gastrointestinal ailments.”
  • “Shark Cartilage (an ingredient in your product) … [h]as anti-inflammatory properties, relief from arthritis, helps diminish psoriasis ….”
  • “White Willow (an ingredient in your product) … Anti-inflammatory, fever reducer. Used for symptoms associated with arthritis, bursitis … migraine headaches, tension headaches and tendonitis.”
  • “Glucosamine (an ingredient in your product) … [i]s commonly used for arthritis.…  It is most often used for a type of arthritis called osteoarthritis.”
  • “Vitamin C (an ingredient in your product) … may include protection against immune system deficiencies, cardiovascular disease … eye disease….”
  • “Curcumin (an ingredient in your product) … [m]ay help inflammatory ailments such as carpal tunnel, arthritis and gout ….”
 
Your Myristoleate Plus Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW products are not generally recognized as safe and effective for the above referenced uses and, therefore, are new drugs under section 201(p) of the Act, 21 U.S.C. § 321(p). New drugs may not be 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 products Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW 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 these products safely for their intended uses.  Thus, the labeling fails to bear adequate directions for their intended uses, causing your products to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).  The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act, 21 U.S.C. § 331(a).
 
We received your letters dated December 10, 2012, and January 7, 2013, responding to the Form FDA‑483, Inspectional Observations, which we issued on December 7, 2012. Overall, your response is inadequate. We have addressed your corrective actions below. We also acknowledge that, during a December 6, 2012, telephone conference with our office, you agreed to voluntarily recall and to cease distribution of your WOW product and the Japan Hokkaido Slimming Weight Loss Pills.
 
Dietary Supplement CGMP Violations:
 
Even if the products discussed above did not have disease claims which make them unapproved new and misbranded drugs, these dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act, 21 U.S.C. § 342(g)(1), in that the products have been prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplement regulations, under 21 CFR 111. Specifically, during our inspection, our investigators observed the following:
 
1.    Your firm failed to make and keep 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 personnel must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by  21 CFR 111.127(h). You provided no written procedures for the approval for release of your dietary supplements by quality control personnel. We have reviewed your response dated January 7, 2013, and determined that it did not address this observation.
 
Because you receive certain products from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). However, your firm did not establish specifications for Myristoleate PLUS Cetyl Myristoleate (CMO) that you received from the manufacturer (b)(4).  We note that in your response dated January 7, 2013, you stated that as of December 5, 2012, you would no longer be labeling any products at your facility. Your firm also did not establish specifications for the WOW product that you received from the distributer (b)(4) for relabeling. As noted above, during our inspection you agreed to recall and cease distributing your WOW product.
 
In addition, as a distributor that contracts with other manufacturers to manufacture, package, or label certain dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution, 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007). Your firm introduces or delivers, or causes the introduction or delivery, of such dietary supplements into interstate commerce in their final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of those products are in compliance with dietary supplement CGMP requirements.
 
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements.  (See United States v. Dotterweich, 320 U.S. 277, 284 (1943) which explains that an offense can be committed under the Federal Food, Drug, and Cosmetic Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws,” and United States v. Park, 421 U.S. 658, 672 (1975) which holds that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act.) In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements.  See 21 U.S.C. §§ 342(g) and 331(a). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
 
You must also establish a system of production and process controls to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing records, 21 CFR 111.55. You must establish and follow written procedures for the responsibilities of the quality control operations, 21 CFR 111.103. The quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing records, 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 indicated to our investigator that your quality control personnel do not review documentation from the manufacturer to ensure the quality of the dietary supplements you distribute and that they are packaged and labeled according to the master manufacturing record.  Thus, you have no documentation of quality control review.
 
2.    Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.  Specifically, you do not have written procedures established for your dietary supplement holding and distributing operations.
 
We have reviewed your response dated January 7, 2013, and determined that you did not address this observation. You indicated in your response that you would address this violation, but to date we have not received any procedures to review or documentation that you are following them.
 
3.    Your firm failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503.  Specifically, there is no written procedure to be followed when any product is returned, including procedures for handling returned dietary supplements that must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515, and for returned dietary supplements that may be salvaged in accordance with 21 CFR 111.520.
 
We have reviewed your response dated January 7, 2013, and determined that you did not address this observation. You indicated in your response that you would address this violation, but to date we have not received any procedures to review or documentation that you are following them.
 
4.    Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the samples using the same container closure system in which the packaged and labeled dietary supplements were distributed, as required by 21 CFR 111.83(b)(1).  Further, the reserve samples must be identified with the appropriate batch, lot, or control number and be held for at least one (1) year past the shelf life date (if shelf life dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with a reserve sample, as required by 21 CFR 111.83(b)(2)-(3).
 
We have reviewed your response dated January 7, 2013, and determined that you did not address this violation.
 
5.    Your firm did not establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560.
 
We have reviewed your response dated January 7, 2013, and determined that you did not address this observation. You indicated in your response that you would address this violation, but to date we have not received any procedures to review or documentation that you are following them.
 
Misbranded Dietary Supplements:
 
Your Myristoleate PLUS Cetyl Myristoleate (CMO), Ultra Ellagic Plus Formula, WOW, and Coral Calcium Formula products are misbranded within the meaning of section 403(q)(5)(F) of the Act, 21 U.S.C. § 343(q)(5)(F), in that the labels do not comply with 21 CFR 101.36. Examples include:
 
  • The ingredient list in your Myristoleate PLUS Cetyl Myristoleate (CMO) product label is preceded by the words “Inactive Ingredients” instead of “Ingredients” or “Other Ingredients” and lists the ingredients silicon dioxide, gelatin, and rice flour inside the Supplement Facts panel.  These ingredients are incorrectly listed inside and must be listed outside of the Supplement Facts panel in accordance with 21 CFR 101.4(g).  These ingredients must be preceded by the word “Ingredients,” unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 21 CFR 101.36(d).
  • Your Coral Calcium Formula product label incorrectly lists “other ingredients” within the Supplement Facts panel. Other ingredients must be listed immediately below or immediately contiguous and to the right of the Supplement Facts panel, in accordance with 21 CFR 101.4(g).
  • Your Myristoleate PLUS Cetyl Myristoleate (CMO) product label does not list the percent of the Daily Value of the dietary ingredient magnesium as required by 21 CFR 101.36(b)(2)(iii) and does not bear a symbol for the dietary ingredient 100 Pure Cerasomal-cis-9-Cetyl Myristoleate (CMO) that refers to the statement “*Daily Value Not Established,” as required by 21 CFR 101.36(b)(3)(iv).
  • The nutrition information for your Ultra Ellagic Plus Formula is not enclosed in a box using hairlines, as required by 21 CFR 101.36(e)(2).
  • Your Ultra Ellagic Plus Formula fails to list the names of dietary ingredients (e.g., Zinc and Selenium) that have established daily values in a specified order as required by 21 CFR 101.36(b)(2). Further, (b)(3)-dietary ingredients must be declared by their common or usual names in a column that is under the column of names described in paragraph 21 CFR 101.36(b)(2)(B), as required by 21 CFR 101.36(b)(3).
  • Your Ultra Ellagic Plus Formula label lists ingredients “Rice Flour” and “Silica” inside the Supplement Facts panel. Under 21 CFR 101.4(g), these ingredients must be listed immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label.  These ingredients must be preceded by the word “Ingredients,” unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 21 CFR 101.36(d).
  • Your WOW product label fails to declare Magnesium, Vitamin C, and Vitamin E, in accordance with 21 CFR 101.36(c)(1). These dietary ingredients contained in the proprietary blend must be declared in accordance with 21 CFR 101.36(b)(2) and dietary ingredients contained in the proprietary blend that are listed under 21 CFR 101.36(b)(3) are to be indented under the term “Proprietary Blend” and listed under the column of names described in 21 CFR 101.36(b)(2)(i)(B).
  • Your WOW product label fails to list the total weight of all other dietary ingredients contained in the proprietary blend on the same line to the right of the term “Proprietary Blend,” in accordance with 21 CFR 101.36(c)(3).
  • Your WOW product label fails to list the quantitative amount by weight per serving and corresponding percent of the daily value for Magnesium, Vitamin C, and Vitamin E, in accordance with 21 CFR 101.36(b)(2)(i)(A) and 21 CFR 101.36(b)(2)(iii). Magnesium, Vitamin C, and Vitamin E are dietary ingredients named under 21 CFR 101.36(b)(2)(i)(B) and ones for which FDA has established daily values as listed in 21 CFR 101.9(c)(8)(iv).
 
Your Myristoleate PLUS Cetyl Myristoleate (CMO) and Ultra Ellagic Plus Formula dietary supplement products are misbranded also within the meaning of section 403(s)(2)(B) of the Act, 21 U.S.C. § 343(s)(2)(B), in that the labels fail to identify the products using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except that the word “dietary” may be replaced by the name of the dietary ingredients in the products.
 
Your Coral Calcium Formula product is misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. § 343(r)(1)(A), because its label contains a nutrient content claim that does not comply with 21 CFR 101.54.  The product label bears the claim “Now with even MORE Vitamin D” but fails to state the identity of the reference food and the level of the nutrient in the reference food, as required by 21 CFR 101.13(j)(1) or 21 CFR 101.13(j)(2).
 
Your Ultra Ellagic Plus Formula, WOW, and Coral Calcium Formula products are misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), in that their labels fail to list capsule or caplet ingredients, in accordance with 21 CFR 101.4(g).
 
  • Your Coral Calcium Formula and Ultra Ellagic Plus Formula products are encapsulated, but some of the capsule ingredients (e.g., gelatin) are not listed on the product labels.
  • Your WOW product is made into a caplet, but the caplet ingredients are not declared on the product label.
 
Your Ultra Ellagic Plus Formula and WOW 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 some of the botanical dietary ingredients are derived in accordance with 21 CFR 101.4(h).
 
Your Ultra Ellagic Plus Formula and Coral Calcium Formula are misbranded within the meaning of section 403(q)(1)(A)(i) of the Act, 21 U.S.C. § 343(q)(1)(A)(i), because their labels fail to list the correct serving size. The serving size for a dietary supplement is the maximum amount recommended on the label to be consumed per eating occasion, in accordance with 21 CFR 101.9(b) and 21 CFR 101.12(b), Table 2.
 
  • The Ultra Ellagic Plus Formula label lists four capsules as the serving size, but the suggested use recommends two capsules, twice daily. Therefore, the serving size for Ultra Ellagic Plus Formula should be two capsules. Also, the quantitative amounts by weight per serving listed in the nutrition information should conform to a serving size of two capsules.
  • The Coral Calcium Formula label lists three capsules as the serving size, but the suggested use recommends one capsule, three times daily. The serving size for Coral Calcium Formula should be one capsule because “3 times daily” implies three eating occasions. Further, the quantitative amounts by weight per serving listed in the nutrition information should conform to a serving size of one capsule.
 
(b)(4) 
 
(b)(4)
 
The above violations are not intended to be an all-inclusive list of violations at your facility or deficiencies in your products or their labeling. We observed other examples of unapproved new drug violations and labeling violations for products that you distribute. Although we recognize that you used statements taken from literature and materials written by others, you are responsible for the labeling of products you distribute, including claims made about those products. In sum, you have a responsibility to ensure that your products are in compliance with the requirements of the Act and its implementing regulations. You should take prompt action to correct the above violations and prevent their recurrence. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
 
You should notify this office in writing within 15 working days of receipt of this letter of the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time within which the corrections will be completed. Furthermore, please advise this office what actions you will take to address product that you have already distributed. 
 
We also have the following dietary supplement labeling comments:
 
Your Myristoleate PLUS Cetyl Myristoleate (CMO) and Coral Calcium Formula product labels present nutrition information with the title “Supplement Facts” that is not in a type size that is larger than other type size in the label. Under 21 CFR 111.36(e)(1), the title must be set in a type size larger than all other print size in the nutrition label, and must be set full width of the nutrition label. In addition, all other headings must be bolded to distinguish them from other information.
 
The dietary ingredients listed on your Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, and Ultra Ellagic Plus Formula labels are not separated by a hairline. Under 21 CFR 101.36(e)(5), dietary ingredients must be separated from one another by a hairline rule centered between the lines of text.
 
Your Myristoleate PLUS Cetyl Myristoleate (CMO) and Ultra Ellagic Plus Formula product labels do not include bars to separate the various sections.  Under 21 CFR 101.36(e)(6)-(7) bars must be used to separate sections of the Supplement Facts panel.
 
In your Myristoleate PLUS Cetyl Myristoleate (CMO) product label, magnesium is declared as 176mg. The Certificate of Manufacture that you provided to us from your contract manufacturer lists Magnesium Stearate 5mg. Please note the inconsistency between the amounts on the label and in the Certificate of Manufacture. An ingredient used to supplement the diet must be declared in accordance with 21 CFR 101.36. However, an ingredient that is not a dietary ingredient or that does not contain dietary ingredients must be declared in accordance with 21 CFR 101.4(g).
 
Your WOW product label contains intervening material in the Supplement Facts panel, including the name and place of business of the distributor, “Contents listed by manufacturer,” “Manufactured in Mexico,” and “Health Enterprises does not substantiate any claims made by the manufacturer.” Under 21 CFR 101.2(e), all information appearing on the information panel shall appear in one place without other intervening material.
 
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 costs related to re-inspection. 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.
 
Please send your written reply to Dr. Brian D. Garthwaite, Compliance Officer, Food and Drug Administration, at the address on the letterhead. If you have questions about this letter, please contact Dr. Garthwaite at (612) 758-7114.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District
 

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