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  5. Paisley Farms, LLC dba Paisley Farm & Crafts - 575934 - 06/04/2019
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WARNING LETTER

Paisley Farms, LLC dba Paisley Farm & Crafts MARCS-CMS 575934 —


Delivery Method:
United Parcel Service
Product:
Dietary Supplements

Recipient:
Recipient Name
Linda F. Ogburn
Recipient Title
Owner
Paisley Farms, LLC dba Paisley Farm & Crafts

Lawrenceburg, TN 38464
United States

Issuing Office:
Division of Human and Animal Food Operations East V

6751 Steger Drive
Cincinnati, OH 45237-3097
United States


 

June 4, 2019

WARNING LETTER 575934

 

Dear Ms. Ogburn:

The United States Food and Drug Administration (FDA) inspected your facility located at (b)(6), Lawrenceburg, TN, from February 4 – 8, 2019. During the inspection we collected product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder products.  Following the inspection, in April 2019, we reviewed your website at the Internet address www.paisleyfc.com and your Facebook page Paisley Farm & Crafts in April 2019.  Your website links directly to your Facebook page, and your Facebook page also links directly to your website, where you take orders for the products Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder.  The claims on your Facebook page establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] 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. 

Additionally, the product labels for your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder do not bear a statement of identity as a dietary supplement, a Supplement Facts panel, or other information suggesting that the product is intended to supplement the diet.  However, your website at www.paisleyfc.com represents these products as “Capsule Supplements” and/or “Health Supplements.”  Even if these products were dietary supplements and not drugs, they would be adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111), and they would be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343].  You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

Unapproved New Drugs

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

From the article, “The Moringa Tree, also know[sic] as the Miracle Tree,” which you posted on January 18, 2018, some of the benefits of Moringa, and ingredient in your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder, include the following:

  • “Has been shown to help lower and regulate blood sugar.”
  • “Has been shown to help with inflamation [sic] within the body.”
  • “The bark, sap, roots, leaves, seeds and flowers have been used in traditional medicines, and may help with control of lipids, cholesterol, and triglycerides.”
  • “The Moringa [an ingredient in Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder] has also been used for animal and livestock to help fight parasitic worms and other internal parasites (has also been known to offer the same benefits in animals as in humans)”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in 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 products Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder 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 Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder 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

If your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder were not unapproved new drugs or misbranded drugs, and if these products were properly labeled as dietary supplements, they would be adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they were prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.  During the inspection, FDA investigators observed the following significant violations of the CGMP regulations for dietary supplements:

1.    You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch of dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplements to ensure the quality of the dietary supplements, as required by 21 CFR 111.70(e).  Specifically, you have not established finished product specifications for the dietary supplements that you manufactured, packaged, labeled, and distributed.

2.    You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d). In addition, you failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications to ensure that you used the specified packaging and to ensure that you applied the specified label, as required by 21 CFR 111.70(g).  Specifically, you have not established any specifications for the packaging and labeling of your dietary supplement products.

3.    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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you do not have written procedures for responsibilities of the quality control operations, and you do not perform or document any of the required quality control operations for the processes you perform, such as material review and disposition decisions.    

Once you have established your quality control written procedures, you must implement them into your manufacturing, packaging, labeling and holding operations, as required by 21 CFR 111.65, and you must implement a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is labeled as specified in a master manufacturing record, as required by 21 CFR 111.55. The quality control personnel must ensure that your manufacturing, labeling and holding operations ensure the quality of the dietary supplement and that the dietary supplement is labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Furthermore, you must have documentation of the quality control personnel review and approval of release or rejection for any labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and 111.140(b)(2).

4.    You failed to prepare and follow a written master manufacturing record for each unique formulation of your dietary supplements 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, during the inspection, you did not prepare and follow a master manufacturing record for your Moringa Oleifera Seed Powder or your Moringa Oleifera Leaf Powder.  Your master manufacturing records must comply with the requirements in 21 CFR 111.210, which include, but are not limited to:

  • The name of the dietary supplement to be manufactured and the strength, concentration, weight, or measure of each dietary ingredient for each batch size [21 CFR 111.210(a)];
  • A complete list of components to be used [21 CFR 111.210(b)];
  • An accurate statement of the weight or measure of each component to be used [21 CFR 111.210(c)];
  • The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)];
  • A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
  • A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21CFR 111.210(g)];
  • Written instructions for specifications for each 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 records [21 CFR 111.210(h)(1)];
  • Written instructions for procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
  • Written instructions for your manual operations to include one person adding the component and another person verifying the addition [21 CFR 111.210(h)(3)(ii)(B)]; and
  • Written instructions for corrective action plans to use when a specification is not met [21 CFR 111.210(h)(5)].

5.    You failed to prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, during the inspection, you did not prepare and follow a master manufacturing record for your Moringa Oleifera Seed Powder or your Moringa Oleifera Leaf Powder.  Your batch production records must comply with the requirements in 21 CFR 111.260.

6.    You failed to identify each unique lot of components that you produced in a manner that allows you to trace the lot to the supplier, the date received, the name of the component and the status of the component (e.g., quarantined, approved, or rejected); and to the dietary supplement you manufactured and distributed, as required by 21 CFR 111.155(d)(1).  Specifically, you do not assign unique identifiers for the lots of Moringa Oleifera leaves and Moringa Oleifera seeds that you use in the manufacture of Moringa Oleifera Leaf Powder Capsules and Moringa Oleifera Seed Powder Capsules that you manufacture, package, label, and distribute.

7.    You failed to establish and follow written procedures to fulfill the requirements related to packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you did not establish written procedures for your packaging and labeling operations. In establishing your written procedures for packaging and labeling operations, you should take note of the requirements that apply to packaging and labels in 21 CFR 111.410 and 21 CFR 111.415, including that you must be able to determine the complete manufacturing history of the packaged and labeled dietary supplement through distribution [21 CFR 111.410(d)].  Although your firm applies expiration dates to the products that consist of a two-digit month and four-digit year, these expiration dates are not sufficient to allow you to determine the complete manufacturing history of the packaged and labeled dietary supplement through distribution.

8.    You failed to establish and follow written procedures for fulfilling the requirement for equipment and utensils, including written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, and for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.25(a) and (c). Specifically, you have no such written procedures.  Once you establish and follow such procedures, you must maintain, clean, and sanitize, as necessary, all equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.27(d). Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning, and sanitizing, as required by 21 CFR 111.27(d)(1). You must ensure that all contact surfaces used for manufacturing or holding lowmoisture components or dietary supplements are in a dry and sanitary condition when in use. When the surfaces are wetcleaned, they must be sanitized, when necessary, and thoroughly dried before subsequent use, as required by 21 CFR 111.27(d)(2). However:

a.  On 2/4/2019, accumulations of ground powder were observed on contact surfaces including, but not limited to, the grinder, grinder sieve, and grinder receiving buckets in the Grinding Area after cleaning operations were completed following the manufacture of dietary supplements including, but not limited to, Moringa Oleifera Leaf Powder Capsules (EXP 10/2020) and Moringa Oleifera Seed Powder Capsules (EXP 10/2020). On 2/5/2019, these conditions were again observed immediately prior to the first production run for the day.

b.  On 2/4/2019, accumulations of ground powder were observed on the shaker attached to the (b)(4) in the (b)(4) Area after cleaning operations were completed following the manufacture of Moringa Oleifera Leaf Powder Capsules (EXP 10/2020). On 2/5/2019, these conditions were again observed immediately prior to the first production run for the day. An employee was observed adjusting the soiled shaker knobs between handling of inprocess leaf powder without changing gloves.

c.  On 2/5/2019, the plastic lid for the container holding Moringa leaves in the (b)(4) Area was in direct contact with the floor. The leaves were added to the grinder to produce leaf powder on 2/45/2019.

d.  On 2/4/2019, the (b)(4) and (b)(4), used to remove dry powder from the (b)(4) on the (b)(4) in the (b)(4) Area, was in direct contact with the floor between usage during the manufacture of Moringa Oleifera Leaf Powder Capsules (EXP 10/2020) and Moringa Oleifera Seed Powder Capsules (EXP 10/2020).

Once the requirements for 21 CFR 111.25 and 21 CFR 111.27 are met, you must make and keep documentation of the date of the use, maintenance, cleaning, and sanitizing of equipment, as required by 21 CFR 111.35(b)(2), as well as documentation of calibration of instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.35(b)(3).

9.    Your firm failed to provide hand-washing facilities that are designed to ensure that an employee’s hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities that are adequate, convenient, and furnished with running water at a suitable temperature, as required by 21 CFR 111.15(i). Specifically, your hand-washing facilities are not convenient to your employees. Your hand-washing facilities are located in the (b)(4). Hand-washing facilities are not available in Building (b)(4), which is used for herb grinding, capsule (b)(4)

10.    You failed to adequately install and maintain plumbing in your physical plant to carry sufficient amounts of water to required locations throughout the physical plant, as required by 21 CFR 111.15(f)(1).  Plumbing is not available in Building (b)(4) which is designated for grinding, capsule filling, and packaging of capsules. During the inspection, employees were required to leave Building (b)(4) and travel outdoors to the (b)(4) to (b)(4) clean filling equipment during the manufacture of dietary supplements.  After cleaning, uncovered filling equipment was transported outdoors back to Building (b)(4).

11.    You failed to prevent animals or pests from entering in any area of your physical plant, as required by 21 CFR 111.15(d)(1). Specifically, you perform labeling and equipment washing activities in (b)(4) located adjacent to your processing Buildings (b)(4), where two pet dogs live. During the inspection the dogs were observed to be in the labeling room while labeling of finished products was being performed, and the dogs were also observed in the (b)(4) where processing equipment is washed.

12.    You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distributed, as required by 21 CFR 111.83(a).  Specifically, you did not collect and hold reserve samples for finished lots of dietary supplements manufactured, packaged, labeled, and distributed during the inspection.

13.    You failed to establish and follow written procedures for manufacturing operations, as required by 21 CFR 111.353.  Specifically, you do not have written procedures for manufacturing operations for dietary supplements.

14.    You 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 for holding and distributing operations for dietary supplements.

15.    You failed to establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21CFR 111.16.  Specifically, you do not have written procedures for cleaning the physical plant for the manufacture of dietary supplements 

16.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553.  Specifically, you do not have written procedures for reviewing and investigating product complaints.

17.    You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503.  Specifically, you do not have written procedures for returned dietary supplements.

Misbranded Dietary Supplements

If you intend to market your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder as dietary supplements, as suggested by your website reference to these products as “Capsule Supplements” and/or “Health Supplements,” the product labeling must comply with the applicable statutory and regulatory requirements for dietary supplements. If these products were dietary supplements, they would be misbranded for the following reasons:

1.    Your Moringa Oleifera Leaf Powder Capsules (300 ct), Moringa Oleifera Seed Powder Capsules (300 ct), and Moringa Oleifera Seed Powder Capsules (500 ct) 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 does not comply with 21 CFR 101.36. Your product labels list the ingredient Moringa oleifera but fail to declare this dietary ingredient inside a Supplement Facts label along with its quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).

2.    Your Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the labeling bears nutrient content claims, but the products do not meet the requirements to bear the claims. Your Facebook page, which is linked to your website www.paisleyfc.com where the products can be purchased, contains an article written by Paisley Farm & Crafts titled, “The Moringa Tree, also know [sic] as the Miracle Tree,” which compares the nutrient content of moringa (an ingredient in Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder) to nutrients in other foods, including:

  • 3 times the Potassium in bananas.
  • 7 times the Vitamin-C as in oranges.
  • 25 times the Iron in Spinach.
  • 4 times the Calcium in milk.
  • 4 times the Vitamin A in carrots.

These are considered “relative claims” in that the statements compare the level of a nutrient in the food with the level of a nutrient in a reference food [21 CFR 101.13(j)]. When labeling bears a relative claim, the labeling must bear, among other information, clear and concise quantitative information comparing the amount of the subject nutrient in the product per labeled serving with that in the reference food, in accordance with 21 CFR 101.13(j)(2)(iv)(A). Your products make implied nutrient content claims that are relative claims, but the labeling fails to bear the quantitative amounts of the subject nutrient in the products in comparison to the reference food.

3.    Your Moringa Oleifera Leaf Powder Capsules (300 ct), Moringa Oleifera Seed Powder Capsules (300 ct), and Moringa Oleifera Seed Powder Capsules (500 ct) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that their 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. Specifically, these products are encapsulated but the capsule ingredients are not declared on the product label.

4.    Your Moringa Oleifera Leaf Powder Capsules (300 ct), Moringa Oleifera Seed Powder Capsules (300 ct), and Moringa Oleifera Seed Powder Capsules (500 ct) products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because their labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g). Based on statements on your website, www.paisleyfc.com, which categorize these products as “Capsule Supplements” and “Health Supplements,” it appears that you are marketing your products as dietary supplements. 21 CFR 101.3(g) requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product or an appropriately descriptive term.

5.    Your Moringa Oleifera Leaf Powder Capsules (300 ct), Moringa Oleifera Seed Powder Capsules (300 ct), and Moringa Oleifera Seed Powder Capsules (500 ct) 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.

6.    Your Moringa Oleifera Leaf Powder Capsules (300 ct), Moringa Oleifera Seed Powder Capsules (300 ct), and Moringa Oleifera Seed Powder Capsules (500 ct) products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that their labels fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. In accordance with 21 CFR 101.5(d), the statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.

7.    Your Moringa Oleifera Leaf Powder Capsules (300 ct), Moringa Oleifera Seed Powder Capsules (300 ct), and Moringa Oleifera Seed Powder Capsules (500 ct) products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the labels fail to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii).

Registration of Food Facilities

The FDA has determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d] and our implementing regulation at 21 CFR Part 1, Subpart H. During an inspection of your facility located at (b)(6), Lawrenceburg, TN from February 4 – 8, 2019, you were (or your representative was) advised of this requirement. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331(dd). (b)(3)(A).

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

(b)(3)(A)

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with 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 your firm complies with all requirements of federal law, including FDA regulations. 

You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Additionally, we have the following comment.  In addition to the above-listed requirements for compliance with 21 CFR 111, please be advised that your firm is required to 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), and you must confirm the identity of other components in accordance with 21 CFR 111.75(a)(2). 

Section 743 of the Act [21 USC 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs.  A reinspection 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.  Reinspection-related costs means all expenses, including administration expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 USC 379j-31(a)(2)(B)].  For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.   If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to Kari L. Batey, Compliance Officer, Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217 or via email orahafeast5firmresponses@fda.hhs.gov.  Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.

 

Sincerely,

/S/

Steven B. Barber

Director, Division V

Office of Human and Animal Foods Operations-East