- Southeastern Pharmaceutical Wholesale, Inc.
- Issuing Office:
- New Orleans District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
August 30, 2016
Warning Letter No. 2016-NOL-12
UNITED PARCEL SERVICE
Delivery Signature Requested
Steven C. Reynier, Owner
Southeastern Pharmaceutical Wholesale, Inc.
2807 Old Hickory Trail
Birmingham, Alabama 35244-1939
Dear Mr. Reynier:
On April 5 and 6, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 2807 Old Hickory Trail, Birmingham, Alabama. Additionally, FDA reviewed your websites at the Internet addresses, www.beta-glucan.com and www.beta-glucan-13d.com, and determined that you take orders for the product Beta-1,3D Glucan, 500 mg capsules. Based on our inspection and review of your product labeling, including your firm’s websites, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations.
Unapproved New Drug
The claims on your website establish that the product is a drug under Section 201(g)(1)(B) of the Act), Title 21, United States Code
321(g)(1)(B), because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s Internet home page at www.fda.gov
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
From the website www.beta-glucan.com:
- “The positive effects of beta glucan in tumor therapy are multiple.”
- “Beta glucan binds to the surface of both macrophages and NK cells, interacts with the surface molecules, and triggers the activation processes. The result of this interaction is that the highly activated tumor killers circulate in our body and actively seek their preferred targets – cancer cells. Upon contact with these cancer cells they kill them in a specific way, so the surrounding tissue and organs remains intact and unharmed.”
- “Since the first direct scientific study (in 1963) clearly demonstrating the antitumor activity of beta-glucan, numerous animal as well as human trials have shown remarkable anti-tumor activity against a wide range of different tumors. In Japan, beta glucan is already licensed as an immunostimulant effective in cancer treatment. Two types of hot water extracts of beta glucan have successfully been used since the 1980s as traditional medicine for cancer therapy in Japan and China.”
- “Without the beta glucan-derived activation of cells, the cancer cells remain coated, but no killing occurs.”
- “Promising results have been obtained from animal studies with beta glucan to protect against for example, pneumonia, Escherichia coli, Staphylcoccus [sic] aureus, and sepsis.”
- “An important finding was that yeast Beta Glucan administration increased survival against antibiotic-resistant infections and that it acted synergistically with a wide-range of antibiotics…”
- “Radiation exposure destroys the bone marrow and depletes the white blood cells that defend against infection and disease. In preclinical research, AFRRI has demonstrated that systemic yeast beta 1,3 glucans enhanced mouse resistance to sub‐lethal and lethal doses of radiation. Beta glucan stimulated bone marrow recovery of white blood cells and increased their infection fighting activity.”
- “Research by the U.S. Armed Forces Radiobiology Research Institute and others have found that systemic beta glucan reduces the time of recovery from radiation‐induced myelosuppression, synergizing with endogenous cytokine and growth factor stimulation of hematopoeisis (formation of blood cells) in the bone marrow. In a preclinical study, white blood cell counts recovered 4 days faster than control animals following a subl‐lethal dose of radiation.”
- “Beta glucan polysaccharides are capable of stimulating macrophages (and other immune cells) and are capable of acting as dietary immunological response modifiers…[t]here is much evidence in scientific literature over the past 70 years indicating that beta glucan stimulates the macrophage to engulf foreign particles more efficiently, fight the growth and spread of tumors and is effective as a preventive treatment in promoting health.”
- “…Only the 1,3 and 1,6 linkages have been proven to bind/dock with the CR3 immune system receptors that activate the tumoricidal (literally, "tumor-killing") activities of the innate cells of the immune system, specifically macrophages, neutrophils, and natural killer cells.”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 USC 331(d), 355(a)]. FDA approves a new drug based on 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 USC 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 (Title 21, Code of Federal Regulations 201.5). Prescription drugs, as defined in Section 503(b)(1)(A) of the Act [21 USC 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your product Beta-1,3D Glucan, 500 mg capsules is 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 product safely for its intended purposes. Accordingly, Beta-1,3D Glucan, 500 mg capsules fails to bear adequate directions for its intended use and, therefore, the product is misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates Section 301(a) of the Act [21 USC 331(a)].
Adulterated Dietary Supplement
Even if your Beta-1,3D Glucan, 500 mg capsules product did not have therapeutic claims which make it an unapproved new drug, the product would still be an adulterated dietary supplement within the meaning of Section 402(g)(1) of the Act [21 USC 342(g)(1)] because the product has been prepared, packed, or held under conditions which do not meet the current good manufacturing practice (CGMP) regulations for dietary supplements in Title 21 of the Code of Federal Regulations, 111 (21 CFR 111).
During the April 5 and 6, 2016 inspection, our FDA Investigators observed the following serious violations of the CGMP regulations for dietary supplements (21 CFR 111):
1. You must establish and follow written complaint procedures which will ensure that complaints are tracked, trended, and thoroughly investigated, as required by 21 CFR 111.553. The review and investigation of product complaints must meet the requirements of 21 CFR 111.560, and be documented and maintained in accordance with 21 CFR 111.570.
Specifically, during the inspection you stated that you received complaints of your Beta Glucan product not working; however, you failed to investigate and record all complaints. Our investigator explained the need to record all complaints for tracking and trending purposes and that each complaint should be thoroughly investigated. At the conclusion of the inspection you stated you would start documenting complaints and keep a complaint file; however, to date you have not provided any evidence that you have established and implemented corrective actions for the management of complaints. We intend to verify the adequacy of that corrective action at a future inspection.
2. You failed to hold dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected, as required by 21 CFR 111.455(a).
Specifically, it was observed during the inspection that the product label states to store in a cool, dry place; however, the product is currently being stored in (b)(4). During the inspection, you told our investigator that you have the ability to heat and cool the garage and promised to keep the area at room temperature even when not in use. We intend to verify the adequacy of that corrective action at a future inspection.
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
The violations cited in this letter are not intended to be an all-inclusive statement of violations, which 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 assure your firm complies with all requirements of federal law and 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/or injunction.
Please respond to this office in writing within 15 working days from the date you receive this letter. You response should outline the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
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 re-inspection-related costs. A re-inspection 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. 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 USC 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 noncompliance 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 reply to Mark W. Rivero, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Mr. Rivero at (504) 846-6103.
Ruth P. Dixon
New Orleans District
cc: Ronald Dawsey, MPH, Director
Alabama Department of Public Health
201 Monroe Street, Suite 1250
Montgomery, Alabama 36130-3017