Some may find it interesting that Delta Institute International would place any emphasis on FDA compliance as a non-US international business organization with its offices, servers, doctors, and manufacturing facilities outside of the geographical boundaries of the United States of America.
However, it’s critical that citizens of the United States, and other western democracies, understand that the FDA is an International Food and Drug Agency, not just a U.S. jurisdictional authority. The FDA has operational posts in many of the 22 countries associated with Delta Institute International Limited... It is therefore critical that members understand the complexities related to the FDA’s Global Task Force, and the necessity to synchronize Delta’s global model with the FDA’s worldwide standardization of health regulation.
The first priority for Delta is for the potential member to understand what Delta’s products and services are, and what they are not. This is a very complex issue as it pertains to definitions regarding drugs, medical advice, dietary supplements, food, medical devices, and the overall intended use of a product or technology with respect to particular jurisdiction. Each of these must be understood in order for the potential member to gain insight with respect to Delta’s efforts to maintain compliance within each particular jurisdiction.Drug Definition SEC. 201. [21 U.S.C. 321]
(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.
This definition underscores the difficulty in avoiding drug regulation. The first part of the definition simplifies compliance to a large extent, which reads; intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. That is easily achievable by way of the various disclaimers, affidavits, disclosures, and education that Delta attempts to provide its members. However, the second statement contains some very broad language as part of the definition of a drug:
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals;
The FDA clearly states that the regulation of supplements, for instance, fall under a different set of regulations than those covering conventional foods. With this in mind, we are expected to define “unapproved drugs” as any supplement which is intended to affect any structure or function within the human body. Under this definition, the following dietary supplements are currently being marketed as “unapproved drugs”:
|Product||Structure of Function|
Marketed for Hydration and Energy Production
Marketed for Constipation and Immune Health
Seems ludicrous, and certainly the FDA does not have a current campaign against these products. However, the two examples illustrate the broad powers claimed by the FDA and the need for clear and accurate disclosures to the consumer regarding the intended use of Delta’s dietary supplement products.Intended Use
It is imperative that the terms “intended use” and “indication for use” are correctly interpreted and applied, given the vast diversity of health issues related to members seeking enrollment. For example, a potential member with Parkinson’s disease using a Delta distributed private label energy catalyst (i.e. X44™, B3L™, Xtole™, etc.), must understand and receive the disclosures related to the purposes for which the products are used, in order for Delta to avoid misbranding violations. Regardless of what a member’s “undisclosed intentions” are, with regard to the use of a supplement for a specific purpose, we want punctuate the importance in order to achieve long term survivability as an organization.
For example, the BX Energy Catalyst, as a label specific product, is only used under certain conditions like IRB’s, or in relation to specific studies conducted at universities, or for other research purposes. In the event that BX is approved as a drug one day, that does not imply that the X44™ Energy Catalyst, for instance, can be used with the intention of treating cancer or other pathologies.
The following affidavit required for enrolling members may seem unnecessary, but not from the perspective of the regulatory authorities in many jurisdictions
Delta Institute International Limited provides members access to its products under private contract club membership and for research purposes under self-administration only. The important thing to understand is that labels have meaning. Not only from the standpoint of identity, contents, ingredients, and disclosures, but from the perspective of intended use. For example, BX energy catalyst should generally be viewed as a general purpose label. The BX Energy Catalyst is not a label that is used for instance in the U.S. or Australia. Each jurisdiction may have specific requirements regarding labeling. Know your labels and their respective intended uses.BX Protocol™ vs. BX Energy Catalyst
Members will often comment on the use of the BX. A statement may include something like; “the bx has helped me…..”. Members should always try and differentiate between the BX Protocol™ and the BX Energy Catalyst, since the BX Protocol™ may include as many as 60 different components, including conventional therapies and third party supplements or products. A BX protocol for one individual may differ from a BX protocol for another and is guided through individual case management and evaluation.Support vs. Targeted Treatment
Often members will describe specific improvements in their pathology, and its related symptoms, after incorporating the BX Protocol™. However, members must understand that improvements can be derived from measures that are not intended as a disease specific treatment. For example, most doctors specializing in neurodegenerative disorders like Parkinson’s disease prescribe the use of vitamin B12 and D for their patients. Patients often report an improvement in mobility and may state that these vitamins have specifically impacted their condition. Understanding vitamin supplementation in the context of Parkinson’s disease as a supportive modality would be similar to one claiming that the BX protocol has helped their specific condition, not as a targeted therapy, but as a supportive modality.
Cancer Treatment Centers of America™ provides another suitable example of general health support or optimization in the context of a specific disease. The center employs the use of nutritional therapy, naturopathic medicine, mind body medicine, and spiritual support, all used specifically with cancer patients in conjunction with conventional therapies as supportive modalities. Furthermore, in the interest of establishing this important distinction, the law requires Delta to clearly state that our products and services are not to be used to replace the services or instructions of a physician or qualified health care practitioner.