Inspections, Compliance, Enforcement, and Criminal Investigations

Bee Products J L 11/14/16

  

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

Public Health Service
Food and Drug Administration
 Atlanta District Office
60 8th St., NE
Atlanta, GA 30309

 

November 14, 2016 
 
VIA UPS OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
 
Ms. Beulah T. Loudermilk, Owner 
J. L. Bee Products, LLC
4008 Barrett Drive, Suite 205
Raleigh, NC 27609-6621
 
WARNING LETTER
(17-ATL-02)
 
Dear Ms. Loudermilk,
 
The U.S. Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 4008 Barrett Drive, Suite 205, Raleigh, NC from March 29-31, 2016. During the inspection we collected your product catalog as well as product labels for your Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips products. The claims in your product catalog establish that your Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips 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, your products are not labeled as dietary supplements, and therefore do not meet the definition of a dietary supplement. See section 201(ff)(2)(C) of the Act [21 U.S.C. § 321(ff)(2)(C)]. However, we note that your website, ww.jlbeeproducts.com, contains a statement that closely resembles the statement required under section 403(r)(6)(C) of the Act [21 U.S.C. § 343(r)(6)(C)], for dietary supplements that make certain labeling claims. Based on your use of this statement, it appears you may intend to market your Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips products as dietary supplements. Even if these products were dietary supplements and not unapproved new drugs or misbranded drugs, they would be misbranded dietary supplements under 403 of the Act [21 U.S.C. § 343] and adulterated dietary supplements under 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in 21 Code of Federal Regulations Part 111 (21 CFR Part 111).
 
You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.
 
We acknowledge receipt of your written response dated April 5, 2016, to the FORM FDA 483, Inspectional Observations. Although your response includes descriptions of how you have corrected or intend to correct the identified deficiencies, we are not able to comment on the adequacy of your response because you have not provided us information with which to evaluate your corrective actions.
 
Unapproved New Drugs and Misbranded Drugs
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
 
BEE POLLEN
 
“In testimonials, Pollen has been shown to help with: Asthma…Anorexia, Constipation, Diarrhea… Prostatism and Impotence, Rheumatism & Arthritis, Colitis, Depression, Insomnia & Arteriosclerosis….”
 
BEE PROPOLIS WITH ROSE HIPS
 
“BEE PROPOLIS THE NATURAL HEALER AN INFECTION FIGHTER”
 
“Bees use propolis as a …natural antibiotic.”
 
“In testimonials, Propolis has been shown to help with: Internal Disease or Dysfunction, Infection or Viral Conditions, Colds & Influenza, Respiratory Distress, Mouth & Ear Infections, Sunburns, Ulcers & Digestive Disorders… Anemia, Burns, Gum and Tooth Problems….”
 
 “propolis has an antibiotic, disease fighting reaction to illness…”
 
“men have used propolis to treat many physical ailments…sore throats, stomach problems, burns, open wounds, such as cuts and scrapes, and other inflammatory diseases.”
 
“Today scientists confirm the outstanding antibiotic, antifungal, analgesic … and antiviral properties…”
 
“numerous investigators have demonstrated that propolis has antimicrobial properties against various bacteria and fungi.”
 
“Bee Propolis is most widely known for its natural antibiotic effect.”
 
“Bee Propolis is an infection fighter.”
 
ROYAL JELLY WITH ROSE HIPS    
 
“In testimonials Royal Jelly is also reported to . . . Increase Resistance to Disease…Vision Problems including Night Vision problems.”
 
 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 Bee Pollen and Bee Propolis with Rose Hips 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 Bee Pollen and Bee Propolis with Rose Hips products fail to bear adequate directions for their intended uses 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)].
 
Dietary Supplement CGMPs
 
If your Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips products 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 the products were prepared, packed, or held under conditions that do not meet the CGMP regulation for dietary supplements in 21 CFR Part 111. 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 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 have not established and followed written procedures for performing quality control operations. 
 
We have reviewed your written response dated April 5, 2016, in which you stated that you have created a standard operating procedure manual. We are unable to determine the adequacy of your corrective actions because you have not provided us information with which to evaluate your corrective actions, such as a copy of the manual. Additionally, note that once you have established your quality control written procedures, you must implement quality control operations in your packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.65.
 
2.    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 have no written procedures for your packaging and labeling operations.
 
We have reviewed your written response dated April 5, 2016, in which you stated that you have created a standard operating procedure manual. We are unable to determine the adequacy of your corrective actions because you have not provided us information with which to evaluate your corrective actions, such as a copy of the manual.
 
3.    You failed to fill, assemble, package, label, and perform other related operations in a way that ensures 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 111.415. Specifically:
 
•  When packaging bee pollen into 120 count bottles on 03/30/16, you did not wash and sanitize the counting trays used to pour the capsules into the pill counting machine and subsequently into the empty bottle [21 CFR 111.415(a)].
 
•  You did not clean and sanitize the work counter prior to using the workspace for packaging operations. On three occasions, you spilled capsules on the workbench and then picked them up and placed them into the product bottle [21 CFR 111.415(a)].
 
•  You failed to assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement from a finished batch of dietary supplement. Although your supplier provides a lot code on the Certificate of Analysis for each batch of dietary supplements sent to you, you do not place this code on, or assign a unique lot code of your own to, the labels used on the packaging of the repackaged dietary supplement product for sale [21 CFR 111.415(f)(1)].
 
We have reviewed your written response dated April 5, 2016, in which you stated that you have implemented a multi-step sanitation process in order to protect the products during packaging operations. Further, you stated that each box and bottle of product now contains lot numbers that correspond with the supplier lot numbers and may be traced to the Bulk Product Inventory Receipt Record. We are unable to evaluate the adequacy of your corrective actions because you have not provided us with information with which to evaluate your corrective actions, such as a copy of your cleaning procedure and records to support its implementation, and specific information regarding your new process for documenting lot numbers.
 
4.    You failed to keep written records pertaining to product distribution for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records, as required by 21 CFR 111.605(a). Specifically, you discard distribution records after three months.
 
We have reviewed your written response dated April 5, 2016, in which you stated that a bulk product inventory receipt record is now in place that will be cross checked for quality control and the receiving and shipment records will be attached to the record and maintained for a minimum of two years. We are unable to evaluate the adequacy of your corrective actions because you have not provided us information with which to evaluate your corrective actions, such as a copy of your shipping and receiving procedure and documentation to support the implementation of the Bulk Product Inventory Receipt record. It is also unclear whether your response, if implemented, would satisfy the specific timeframes for recordkeeping established in 21 CFR 111.605(a), i.e., that the records be maintained for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records.
 
5.    You failed to establish specifications to 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). Specifically, you have not established procedures for receiving product for packaging and labeling as a dietary supplement. 
 
We have reviewed your written response dated April 5, 2016, in which you stated that the procedures are now listed in your operations manual and that each product will contain the information required by the FDA when processed for shipping. We are unable to evaluate the adequacy of your corrective actions because you have not provided us with information with which to evaluate your corrective actions, such as a copy of the manual.
 
6.    You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). Specifically, you do not maintain reserve samples .
 
We have reviewed your written response dated April 5, 2016, in which you stated that for each lot repacked a reserve sample will be set aside and will be kept for two years past the expiration date. We are unable to evaluate the adequacy of your corrective actions because you have not provided us with information with which to evaluate your corrective actions, such as a copy of your reserve sample handling procedure or other supporting records to demonstrate that the procedure has been implemented.
 
7.    You failed to make and keep a written record of every product complaint related to good manufacturing practice, as required by 21 CFR 111.570(b)(2). Specifically, you do not keep a written record of each complaint received.
 
We have reviewed your written response dated April 5, 2016, in which you stated that you will maintain a written record of any and all complaints that will reflect the nature of the complaint, other investigation information, and a follow-up to the complaint. We are unable to evaluate the adequacy of your corrective actions because you have not provided documentation of how your plan will be implemented.  
 
Misbranded Dietary Supplements
 
If you intend to market your Bee Pollen, Bee Propolis with Rose Hips, and Royal Jelly with Rose Hips products as dietary supplements, our label review shows that these products are not properly labeled as dietary supplements. If you intend to market your products as dietary supplements, they 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 products would be misbranded within the meaning of section 403(s)(2)(B) of the Act, 21 U.S.C. § 343(s)(2)(B) because your product 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 the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product or an appropriately descriptive term.
 
2.    Your “Bee Propolis with Rose Hips and Royal Jelly with Rose Hips” products would be misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
 
3.    Your products would be misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because they are fabricated from two or more ingredients, and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). The ingredient list must be preceded by the word "Ingredients," or ”Other Ingredients” in accordance with 21 CFR 101.4(g). The ingredients list must include not only the dietary ingredients but also the capsule ingredients for products in capsule form.
 
4.    Your products would be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the labels fail to bear nutrition labeling (“Supplement Facts” panel), as required by 21 CFR 101.36.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or 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 that your firm complies with all requirements of federal law, including FDA regulations.
 
You should take prompt action to correct all of 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. 
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 
 
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990, x16 or write her at the noted address. 
 
Sincerely,
/S/
Ingrid A. Zambrana
District Director
Atlanta District Office

 

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