- Drucker Labs LP
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
December 20, 2013
Sent via UPS Overnight
Return Receipt Requested
Richard A. Drucker, Owner
Drucker Labs L.P.
1600 Capital Ave, Suite 100
Plano, Texas 75074-8187
Dear Mr. Drucker:
On June 19 through July 13, 2012, the U.S. Food and Drug Administration (FDA) inspected your firm, located at 1600 Capita! Ave., Suite 100, Plano, Texas.
During the inspection, we found that your firm is a manufacturer, labeler, and distributor of dietary supplements.
FDA reviewed your Internet website at www.druckerlabs.com
in December 2013 and has determined that you take orders there for your intraMAX, intraMIN, and intraKID products, which the website promotes 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)]. The therapeutic claims on your website establish that your products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
You may find the Act and the implementing regulations through links in FDA's home page at www.fda.gov
Examples of the website claims that provide evidence that your products are intended for use as drugs include:
• "intraMIN should be used by Health-Care Professionals as the first line of choice for patient's healthcare issues that will benefit from Organically microcomplexed™ minerals until the patient is physically stabilized. It is
• best to remove all other kinds of nutritional supplementation and focus only on intraMIN."
• "intra MIN Topical Spray Protocol ... Spray on dermatological conditions ... acne, psoriasis, eczema ... and varicosities (varicose veins)."
• "intraMIN Soaking Protocol ... Soak gauze in unflavored intraMIN and apply to osteo or rheumatoid arthritic joints ... "
• "Diabetes: Take one ounce of unflavored intraMIN thirty-minutes after each diabetic medication. Introduce flavored intraMAX after means when patient's blood sugar begins to stabilize ... "
• "Fibromyalgia: ... use unflavored intraMIN as a topical spray or in a gauze to soak into the trigger points ... "
• "intraKlD should be used by Health-Care Professionals and Doctors as the first line of defense for children's nutritional support and maintenance."
• "It is best to eliminate all other kinds of nutritional supplementation and use only intraKID."
• "Use this Less is More Protocol if you have anyone with ... depression, cancer, gastrointestinal disorders, Lyme disease ... ADD/ADHD ... bone disorders ... allergies, neuromusculo [sic] disorders, skin disorders .. alcoholism . . . . "
• In the article "Dr. Drucker's Philosophy of Health":" Drucker Labs' premier product, intraMAX, works in ... assisting the body in preventing allergies, colds, and the flu, building and repairing blood, bones, muscle, tissues, joints, ligaments and tendons ... "
• In the article "Why Feeding Your Pediatric Nutrition Component is Vital": The four most common problems I see in the children ... are autism, allergies, ADHD and asthma ... In each instance, poor nutrition figures prominently ... To this list of conditions ... allergies ... and hormonal imbalances, such as estrogen dominance - a cause of feminization in boys and premature menstruations in girls. Also gallbladder problems, gastritis, ulcers, and parasites.... At the root of all is a body lacking in vitamins, minerals, essential amino acids... providing liquid nutrition product such as intraKID™ which is created and manufactured by Drucker Labs of Plano, Texas .... Everything from behavioral labels to seizures is ameliorated ... "
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)]. A new drug may not be legally 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.
Further, your intraMAX and intraMIN products 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 drugs safely for their intended uses. Thus, these drugs are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for use. 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)].
The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims which can be found at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.93
(codified at 21 CFR 101.93(g)).
This letter is not intended to be an all-inclusive list of the violations at your facility or that exist in connection with your products or their labeling. 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 facility and the products you market comply with the Act and its implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations cited above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
In addition to the violations discussed above, we have the following comment:
We note that the inspection revealed a number of serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111), Including failure to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103 and 21 CFR 111 .140(b)(1), and failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement 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). We received your written responses to the Form FDA 483, including your most recent written responses dated October 11, 2013 and December 16, 2013. Your written responses appear to adequately address the dietary supplement CGMP violations, however, we will verify the adequacy of your corrective actions during our next inspection.
Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct the violations cited above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Shari Shambaugh, Director Compliance Branch, at the above letterhead address. If you have any questions regarding any issue in this letter, please contract Ms. Shambaugh at 214-253-5215.
Reynaldo R. Rodfiguez, Jr.
Dallas District Director