Inspections, Compliance, Enforcement, and Criminal Investigations

Cape Fear Naturals 3/2/17

 

  

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March 2, 2017
 
VIA UPS OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
Lynda A. & James W. Whitley, Jr.
Cape Fear Naturals, LLC
313 Friday Drive
Wilmington, NC 28411
 
WARNING LETTER
(17-ATL-05)
 
Dear Mr. and Mrs. Whitley:
 
On September 13 & September 15, 2016, the U.S. Food and Drug Administration (FDA) inspected your facility located at 313 Friday Drive, Wilmington, NC 28411. Our inspection determined that your firm distributes products which you have manufactured for you and then label as dietary supplements and distribute under your firm’s name. You also manufacture topical products such as creams and deodorants. 
 
The inspection found that your facility has significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), 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 the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. 
 
In addition, during the inspection, our investigator collected finished product labels for your dietary supplement and topical products. We also reviewed labeling on your website, www.capefearnaturals.com, which is used to market your products.
 
Our review of your product labeling and Internet website where you market your products revealed serious violations of the Act and applicable regulations. You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.  
 
Unapproved New Drug Violations and Misbranded Drugs
 
This is to advise you that we reviewed your website at the Internet address www.capefearnaturals.com and your online store at Amazon.com in November 2016 and have determined that you take orders there for the products Acidophilus, Beta Carotene, Curcumin Extract, DIM capsules, NAC capsules, Beta Glucan capsules, and Quercetin, as well as your topical creams including Beta Glucan cream, Kojic Acid cream, 1% a-Arbutin cream, 2% super a-Arbutin cream, and Retinol-A cream. The claims on your website, as well as your product labels, establish that the products are drugs under sections 201(g)(1)(B) and/or 201 (g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.   As explained further below, introducing or delivering these for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Acidophilus capsules
  • “Prevent and treat diarrhea”
  • “Relieve irritable Bowel Syndrome, Crohn’s disease, and gut dysbiosis.”
  • “Decrease frequency of vaginal yeast infections and urinary tract infections”
  • “Treat respiratory infections”
  • “Improve Blood Pressure and Cholesterol “ 
Beta Carotene capsules 
  • “[S]tops free radical damage…” 
Curcumin Extract capsules 
  • “[A]nti-inflammatory agent” 
DIM capsules
  • “[E]ncouraging results in the battle against cancer have been seen from DIM”
  • “DIM is a super-antioxidant that has been shown in studies to help prevent cancer and other chronic diseases.”
NAC capsules 
  • “It is thought to help the body combat conditions such as bronchitis.” 
Quercetin tablets
 
Website
  • “It … has anti-inflammatory & anti-histamine properties.” 
Product Label
  • “[A]nti-histamine & to help with inflammation”
Beta Glucan capsules 
  • “[N]ormalize cholesterol” 
Beta Glucan Cream 
  • “[S]timulation of collagen synthesis”
  • “[W]ound healing”
  • “Immunostimulant”
  •  “[T]reat skin conditions like acne…poison ivy...”
  • “[U]seful for conditions such as cancer, high cholesterol and heart disease too.”
Retinol-A Cream 
  • “[H]as also been found to help acne scars, rosacea, warts, and dermatitis” 
Kojic Acid Cream
  • “[T]o lighten… & even skin tone” 
Retinol-A Cream 
  • “[H]as also been found to help acne scars, rosacea, warts, and dermatitis” 
1% α-Arbutin Cream and 2% Super α-Arbutin Cream  
  • “[T]o lighten and even skin tones, age spots and freckles” 
Your Acidophilus, Beta Carotene, Curcumin Extract, DIM capsules, NAC capsules, Beta Glucan capsules, and Quercetin, as well as your topical creams including Beta Glucan cream, Kojic Acid cream, 1% a-Arbutin cream, 2% super a-Arbutin cream, and Retinol-A cream 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 USC 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 Acidophilus capsules, DIM capsules, and NAC capsules 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, Acidophilus capsules, DIM capsules, and NAC capsules 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 CFR Part 111.
 
As a distributor that contracts with other manufacturers to manufacture, package, or label 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 the dietary supplement into interstate commerce in its 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 that product 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 supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements, see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the FD&C 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 FD&C Act). In particular, the FD&C 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.  
 
During the inspection our FDA investigators observed the following significant violations of the CGMP regulations for dietary supplements:
 
1.    You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. During the inspection, you acknowledged to our investigator that you do not have written procedures.
 
We acknowledge your response, received September 27, 2016; however, we find your corrective action to be inadequate.  Although you provided a document entitled Standard Operating Procedures in response to FDA 483 Observation 1, the document does not include procedures to ensure components and dietary supplement products are held and distributed under conditions that prevent contamination, deterioration, and mix-up, as required under 21 CFR 111.455(c). 
 
2.    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. During the inspection, you acknowledged to our investigator that you do not have written quality control procedures.
 
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 for producing the dietary supplement 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 111.65.
 
We acknowledge your response, received September 27, 2016; however, we find your corrective action to be inadequate. You indicate that you have established and follow written procedures for quality control; however, we are unable to evaluate the adequacy of your response because you failed to provide documentation of your written procedures.
 
3.    You did not establish and follow written procedures to review and investigate product complaints, as required by 21 CFR 111.553. Specifically, you do not have any written procedures for handling, investigating, and recording product complaints.
 
Once you have established written procedures, your written complaint procedures must include the requirements for how you review and investigate your product complaints, as required by 21 CFR 111.560. Specifically, your product complaint procedures must specify that a qualified person review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirement of 21 CFR Part 111 (see 21 CFR 111.560(a)), quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed (see 21 CFR 111.560(b)), and specify that the review and investigation of the product complaint must extend to all relevant batches and records (see 21 CFR 111.560(c)). Furthermore, you did not provide evidence that you are making and keeping record of every product complaint that is related to good manufacturing practice in accordance with 21 CFR 111.570(b)(2). During the inspection you stated that your policy is to refund or replace any products that are the subject of a complaint, but no investigation into the root cause of the complaint is conducted.
 
We acknowledge your response, received September 27, 2016; however, we find your corrective action to be inadequate. You indicate that you address complaints; however, the process described is inadequate because it does not meet the requirements for reviewing and investigating product complaints in 21 CFR 111.560.
 
4.    You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. During the inspection, you acknowledged to our investigator that you do not have written procedures.
 
We acknowledge your response, received September 27, 2016; however, we find your corrective action to be inadequate. You indicated what you do when a product is returned to you, however, this process fails to include steps to conduct an investigation in the event the nature of the complaint and return implicates other finished product bathes.
 
5.    You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. During the inspection, you acknowledged to our investigator that you do not have written procedures for in-house labeling of dietary supplements sold by your firm.
 
We acknowledge your response, received September 27, 2016; however, we find your corrective action to be inadequate. You provided a copy of Standard Operating Procedures and Labeling Operations Explained which describes your labeling process. However, they do not include requirements for how you control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies.
 
Misbranded Dietary Supplements
 
1.    Your DIM (Diindolylmethane) and Lipoic Acid 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 product labels and website labels for each product contains a structure function claim; however, your labels and labeling fails to bear the FDA disclaimer statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
 
2.    Your DIM (Diindolylmethane), Lipoic Acid, Quercetin, Vitamin E, and Beta Glucan products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements.
 
3.    Your Vitamin E, Quercetin, and Beta Glucan 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 presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101 .36. For example:
 
a.  Your Vitamin E product label fails to declare the %Daily Value for the Vitamin E, as required by 21 CFR 101.36(b)(2)(iii). We also note the label incorrectly states “% Daily Value not established.”
 
b.  Your Vitamin E, Quercetin, and Beta Glucan product labels fail to declare the source of the dietary ingredient in the supplement facts label. The source ingredient may be listed either in the Supplement Facts label or in the ingredient list, or in both, per 21 CFR 101.36(d), 101.4(g), and 101.4(a).
 
This letter is not intended as an all-inclusive list of the violations that exist in connection to your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. 
 
You should take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure and injunction.
 
We offer you the following labeling comment:
  • The Supplement Facts Panels do not list a symbol that links to the statement “Daily Value not established” on your Quercetin and Beta Glucan product labels. Other dietary ingredients shall bear a symbol (e.g., an asterisk) in the column under the heading of “% Daily Value” that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement “Daily Value not established,” except that when the heading %Daily Value” is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient, per 21 CFR 101.36(b)(3)(iv). 
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.
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made. 
 
Your reply should be sent to the following address:
 
Janice L. King
Compliance Officer
U.S. Food and Drug Administration
4600 Goer Drive, Suite #106
North Charleston, SC 29406
 
If you have questions regarding this letter, please contact Janice L. King, Compliance Officer at 843-746-2990, x16 or janice.king@fda.hhs.gov.
 
Sincerely,
/S/ 
Ingrid A Zambrana
District Director
Atlanta District Office
Southeast Region, Office of Regulatory Affairs
U.S. Food and Drug Administration
 

 

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