National Health Freedom Coalition

This memorandum has been completed in response to a request to research the laws regarding the provision of colostrum therapy health care services in the state of Minnesota. The research does not include research on corporate or clinic structure or laws relating to the setting-up of a health care facility in general but rather focuses on the issues surrounding the use of colostrum therapy itself.

The proposed project (hereinafter referred to as The Project) would involve the set-up of a center where persons seeking health would come to the center and the center would guide them through a process as follows: each person would provide a small amount of whole blood which would then be injected into the udder of a pregnant cow exclusively earmarked for that individual, and the process would be repeated at specific intervals during the cows pregnancy, and upon the cow birthing, portions of the colostrum would be given to the person who had provided the whole blood to that particular cow so that the person could ingest the customized colostrum for their own healing. In addition, the project would include using specific antigens such as Borrelia burghdorfia (Lymes disease antigen) to produce colostrum for some patients.

This project, although involving a seemingly straightforward plan, encompasses a large number of areas of law, the interplay of which are extremely complex. The memorandum spells out legal concepts that are relevant to the proposed project and their interrelationship with each other. The memorandum concludes with a summary and risk assessment for The Project.

Laws most directly impacting this project are the following: 1) Laws regarding substances regulated by federal and state governments and 2) State laws regarding health care practitioners and their ability to practice their trades, and public health laws.

We begin with substance law because it helps clarify what the treatment actually will be and what laws will apply. Substances are generally regulated by federal and state laws and a discussion of when federal jurisdiction is limited to interstate commerce as opposed to federal jurisdiction over intrastate commerce will be important. In contrast, health care practitioner law is generally reserved to the states however there are certain circumstances where federal law impacts practitioner practices as well.

Firstly we review federal substance law to discern whether the Project’s substances would be under the jurisdiction of the federal government. The project proposes to involve at least three substances, and all of which might potentially be regulated by federal laws and rules. The substances are: 1) Human blood; 2) Borrelia burghdorfia antigen; and 3) Immune colostrum.

Identifying which category a substance is in is the first step towards guiding the path a substance will take within the law. According to federal law, relevant classifications for this project would be whether the substance is; a “drug”, a “food”, a “food additive”, a “dietary supplement”, a “human biologic”, or an “animal biologic”. Food and dietary supplements are generally regarded as presenting less potential for harm to the consumer and receive less regulation than new drugs or biologics. Substances added to food (food additive) are generally regarded as potentially more harmful than foods but less harmful than drugs. For purposes of this project it will be extremely important to determine whether a substance is considered a drug or biologic, or whether it is consider a food or dietary supplement.

The following definitions differentiate these categories.
The FDCA is the federal law for the Federal Drug Administration. The FDCA broadly defines “drug” as follows:

NOTE: A key element in the definition of drug, and often times litigated, is whether a substance has an intended use and the statutory definition indicates that “whether a product is a drug depends on its intended application.”
The FDCA defines “food” as follows:

NOTE: It is important to note that a food does not lose its status of food just because it puts a health claim label on it. Pre-approval of health claims is possible through special regulations of the FDA. The FDCA defines “dietary supplement” as follows:“…(ff) The term ''dietary supplement'' –

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(2) means a product that -

The definitions of “drug”, “animal drug”, “food” and “dietary supplement” are all included in the FDCA law. However “human biologics” and “animal biologics” are referenced in other statutes. The history of FDCA is lengthy and complex, having been amended over 57 times since 1938 . Other federal laws with even earlier origins, include the Public Health Service Act (PHS) regulating human biologics , and the Virus, Serum and Toxin Act (VSTA ) under the U.S. Department of Agriculture and Animal and Plant Health Inspection Service regulating non-human animal biologics. These statutes interface with FDCA in direct and complex ways.

The PHS defines biological product as follows:

The definition of animal biologics is found in VSTA under the Department of Agriculture laws as follows:

Animal biologics are further clarified in terms of definition by the Code of Federal Rules as follows:

“….Biological products. The term biological products, also referred to in this subchapter as biologics, biologicals, or products, shall mean all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics), or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term ``biological products'' includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components, that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies.

NOTE: These biologics are applicable for treatment of animals.
In the case of a “drug” the FDCA mandates that before a drug is marketed to the consuming public it’s safety and efficacy must be established.

The term “new drug” is defined as follows:

“(p) The term ''new drug'' means -

The application of each of these categories has it’s own intricacies. For example, proponents of several natural unorthodox cancer treatments (most notably laetrile) have argued that their drug was not a “new drug” within the meaning of the federal Act and that “experts” recognized its safety. However they did not prevailed in the courts . In response to this dilemma, a number of states have passed laws allowing for the use of laetrile in their state, however there are concerns that if these state laws were challenged they might be pre-empted by the federal Act . In the case of a “food” or “dietary supplement”, the FDA may deem them misbranded if they make health claims outside of the federal regulatory allowances. Regarding food in particular:

“Sec. 343. A food shall be deemed to be misbranded (r )(1) Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or labeling of the food which expressly or by implication –

Dietary supplements hold a special place in the federal law. Referencing and regarding the paragraph (B) above, dietary supplements have a special ability to make labeling statements regarding health as follows:

(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if -

A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.” The FDA has authority to make proposed regulations regarding labeling in order to promote, ban, or modify a proposed claim. But only if it finds “significant scientific agreement” among experts that the claim is supported by available evidence. “Courts have indicate that the FDA must explain what it means by significant scientific agreement or at minimum what it does not mean.” In the case of a “new drug”, obtaining approval involves controlled clinical trials and large financial investments and an application for an IND (Investigational New Drug.) This can be very intimidating to a small producer with limited funds. However, even if a product has an intended drug purpose, a product is not a “new drug” within the meaning of the FDCA if its composition is such that it is “…generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof,… “A finding that a product is “generally recognized” by experts as safe and effective for its intended use must be supported by substantial evidence as defined in 21 U.S.C.A. Sec 355(d) (for new drugs)…” An example of the importance of how a product is categorized is exemplified in U.S. v. Veterinary Products for Use . This case dealt with colostrum for animal use. The United States attempted to condemn six products manufactured by Iowa company Immuno-Dynamics as unsafe and adulterated new animal drugs. “Immuno-Dynamics protested the need for such approval, contending that these products are mere nutritional supplements or food and not drugs subject to FDCA regulation.” Since the statutory definition of a new drug indicates that “Whether a product is a drug depends on its intended application”, the courts accepted evidence of intent including product labels and promotional materials accompanying the product and any materials being distributed with the product that customers relied on. The court then explored evidence regarding the concept that even if the product labeling or written materials evidence some intended drug purpose, a product is not a new animal drug if its composition is such that it is generally recognized among experts as safe and effective for use as suggested in the product’s label or if, as a result of investigations to determine its safety and effectiveness, it has become recognized as safe and effective for the recommended use. The Court of Appeals in this case agreed that it was proper to submit these questions to a jury and upheld the jury verdict in favor of Immuno-Dynamics that the products were not new drugs. However in an earlier case, U.S. v. Pro-Ag Inc. , the courts found that Impro Products Inc. of Waukon, Iowa, manufacturers of colostrum based products, could be enjoined from marketing these products in interstate commerce because the definition of drug applied to them “because they ‘are designed and intended to be applied directly to dairy cows and change the function of the cows.” (affecting the milk production and the amount of feed required). In addition the courts found that the products were not shown to be generally recognized by qualified experts as safe and effective for their labeled indications thus they fell under the new drug regulatory requirements. In the case of a new drug requiring a new drug application, or of a food or dietary supplement wishing to make a health claim, research is an important component of the process. Companies that propose to develop drugs or health claims on products perform and collect this research to support their products and product applications for approval. In the case of food and dietary supplements that do not pose a risk of safety to the public, clinical trials are often set up, under a proper Independent Research Board (IRB,) within a state and according to all state laws regarding the subject matter, and following federal protocols for research and the use of human subjects. For “new drugs”, intended for use in the treatment of disease, an IND may be necessary to proceed.

In addition to federal substance laws many states have their own mini-FDA laws, which regulate the manufacture and marketing of products intrastate (within the state). For example in many areas Minnesota law conforms closely with the federal Food, Drug, and Cosmetic Act requirements. But an example of non-conformity is Minnesota’s rule 1720.0640 stating that the “rules shall not apply to biological products and antigens manufactured and sold exclusively for use in poultry;…”

The FDCA indicates that the FDA’s jurisdiction over unapproved new drugs is limited to introduction into interstate commerce. In addition, jurisdiction over interstate commerce can, in some circumstances, be extended to state activity where the state activity works to undermine the broad mission of the FDCA. Given these parameters, if a new drug is manufactured within a state and there is no intention of introducing a product into interstate commerce, it may be that the FDA will not be able to regulate. Two examples of this dynamic are as follows:

The Burzynski cases had to do with Dr. Burzynski MD, and a substance used to treat human disease. In 1985, Dr. Burzynski MD of Texas, was enjoined by FDA from distributing an unapproved and controversial cancer treatment that he had himself manufactured in the state of Texas. In this case, the agency obtained injunctive relief under the new drug provisions of the FDCA, which prohibit introduction of unapproved new drugs into interstate commerce. The agency’s relief did not extend to intrastate sales. However soon thereafter the state of Texas Board of Medical Examiners attempted to stop his activities under Texas law. In 1996, after a long legal path, a Texas Court of Appeals upheld the Texas Board of Medical Examiners order that suspended Dr. Burzynski’s license to practice medicine based on an interpretation of Texas law that“….does not allow physicians to prescribe non-FDA approved drugs.”

Another example where the FDA declined to establish jurisdiction is the Saunders case . Saunders recommended, developed and provided individually customized colostrum to consumers who were requesting the colostrum product for health care purposes. The FDA completed a two-year undercover investigation of Saunders and declined jurisdiction. The state then underwent an undercover investigation and filed charges under state law of fraud, swindle, cruelty to animals and practicing medicine without a license. All of the charges except practice of medicine without a license were dropped before the first trial. The final charges of practicing medicine were dropped by state prosecutors after two hung juries.

VSTA which oversees animal biologics under the Department of Health is different than the FDA jurisdiction for new drugs in that VSTA regulates both interstate and intrastate vaccines. Regarding VSTA, Congress found that federal regulation over all animal vaccines was “necessary to prevent and eliminate burdens on commerce and to effectively regulate such commerce.” . .

Given the above laws and discussion the following is a review of each substance in The Project separately.

Antigen Borrelia burghdorfia:

The fact that Borrelia burghdorfia antigen is proposed in The Project to be used to “vaccinate animals” indicates that it might fit within the definition of an animal biologic. VSTA has jurisdiction over animal biologics. Any new animal biologic antigen manufactured or used would need to comply with VSTA regulations. However if an already licensed Borrelia burghdorfia vaccination is being used to directly vaccinate animals, then the federal laws for manufacturing and selling a new product would not apply.

In the case of the use of an unlicensed and unapproved Borrelia burghdorfia antigen, where the antigen is either made available in some form in the state or is being isolated from a patient’s blood, and intended to be used to develop a specific colostrum, the antigen in this case would not be actually being used for purposes of treating an animal’s health but rather for developing a human product and outcome. This would indicate that as a biologic it would not be able to be approved for the benefit of the animal. If it cannot be approved then we need to ask the question, what are the circumstances that an unapproved animal biologic can be used. We find that according to VSTA, unapproved animal biologics are exempted from need for licensure if: prepared by veterinary practitioners solely for administration to animals in the course of a state licensed professional practice, products prepared by a person solely for administration to animals owned by that person, or products prepared solely for distribution within the State of production pursuant to a license granted by such State. In the case of the use of a already licensed antigen, these exemptions would not be necessary.

An interesting note of United States and Minnesota history regarding the use of antigens and cows: On September 25, 1963, Honorable Albert H Quie, Congressman from Minnesota in the House of Representative, read into the record a statement summary of his comments regarding a study being conducted by W.E. Petersen Research Institute of St. Paul, Minnesota, on the physical and financial values of immune milk. His comments described antibody being synthesized locally in the mammary gland stimulated by direct immunization through the teat canal. He also pointed out beneficial experiments with people suffering from arthritis and meningitis with sufficient remissions of infection.

Whether or not the Project involves an approved or unapproved antigen, the laws regarding practitioner and consumer use of vaccines is relevant and must be considered.

It is common knowledge that animals are often vaccinated by Veterinarians, farmers, animal owners, and Veterinarian assistants with purchased vaccines, some over-the-counter products, and some prescription drug products only. A look at Minnesota Veterinarian law and Animal law shows the parameters a person must follow in such practices.

Health Care Practitioner Laws:

Minnesota Board of Veterinary Medicine law states that:

There are limitation on this broad scope of practice most notably (d) and (g) as follows:

“ Subd. 2. Authorized activities. No provision of this chapter shall be construed to prohibit:

The broad scope of practice laws described above give Veterinarians exclusive jurisdiction over the medical care of animals. In some circumstances, these statutes may make a lay person vulnerable to charges of practicing Veterinary Medicine if a person vaccinates an animal. In addition to these exclusive rights, Veterinarians themselves must follow the laws of their own practice acts in order to remain in good standing with their practice Boards. The most notable part of practice acts regarding standard of care is the fact that licensed health care practitioners in general can lose their licenses for practicing outside of the minimum standards of acceptable and prevailing practice. The acceptable and prevailing practice may not be the practice of choice for a Veterinarian who practices in innovative projects. The Minnesota Veterinarian Act includes the following in their grounds for disciplinary actions:

“…(11) fraud, deception, or incompetence in the practice of
veterinary medicine, including any departure from or failure to
conform to the minimum standards of acceptable and prevailing
practice without actual injury having to be established;

The requirement to abide by conventional medically prevailing scientific parameters, even without actual injury having to be established has motivated almost 20 states to pass laws that allow Medical Physicians to expand their ability to practice to include complementary and alternative care services. Each state has approached this problem with different legal language, some more successfully than others. Florida recently passed such a law that not only includes Medical Doctors but applies to all licensed health care providers. Most recently, National Health Freedom Action has drafted proposed legislative language for states to consider when drafting these types of practitioner statutes . The new state language will allow licensed practitioners of all kinds to expand their options for providing treatments at the same time provide proper informed consent and disclosures to consumers. Whether this type of statute is adequate for animal practitioners is a question.

In Minnesota an important component of the Veterinary law is that the Veterinarian must have a veterinarian-client-relationship.

In light of the above laws of Veterinary medicine it will be important in The Project to discern whether the vaccines being given to the cow or other animal are within the prevailing and accepted standard of care of the licensed provider or its delegated assistant, whether there are circumstances where a Veterinarian might do certain things during research, or whether the state law has adopted an expanded practice act which would include Veterinarians such that they could go beyond the accepted and prevailing standard of care in some circumstances and parameters according to the new law.

Disease Reporting Laws:

In addition to practice acts, licensed health care practitioners are often mandated to report various types of diseases. Physicians must report diseases included in a specific list “when attending a case, suspected case, carrier, or death…” The reportable list included Borellia burgdorferi. “…GG. Lymes Disease (Borellia burgdorferi)” Health care facilities and medical laboratories must also report disease. In Minnesota case the Veterinarian rules are as follows:
.
“Subp. 5. Veterinarians and veterinary medical laboratories. The commissioner of health shall, under the following circumstances, request certain reports of clinical diagnosis of disease in animals and reports of laboratory tests on animals:

Cruelty to Animals:

Another area of law relevant to The Project is law regarding cruelty to animals. Although the vaccination of animals is a common practice, whether or not a vaccination would be considered cruelty to an animal is a factor to be considered. Veterinarians as well as laypersons are prohibited from mistreating animals. The following are excerpts from the Minnesota statutes regarding this issue:

There is much evidence that many vaccines enhance the health and performance of cows and animals. However, given the nature of The Project, and the unusual use of whole blood and Borellia burgdorferi, cruelty to animal issues should be at least considered. Information from researchers should be gathered with experience in the injection of cows to assure the safety of this type of vaccinations. To contribute in that regard, in the Minnesota case of State v. Saunders, a case of a farmer using cows to develop immune colostrum to provide to consumers, and charged with “practicing medicine without a license”, the original complaint included charges of “cruelty to animals”. However the charges were dropped before criminal trial. The reason for dropping the charges is unknown however it is believed that there was a lack of evidence for the charge.

Injecting substance into the teat canal of a cow is a common practice in veterinary medicine, especially for the use of antibiotics for mastitis. However the injection of whole human blood into the teat canal is not common but has been done in research settings. In fact some of the original research on this process was done by a doctor in Germany, almost 50 years ago. In Saunders, there was expert witness testimony that indicated that historical Native American customs included rubbing the whole blood of a sick person onto the outside of the mammary gland of a pregnant horse during the horse’s pregnancy in order to affect the healing qualities of the future colostrum. This is similar in concept to The Project’s proposal except that The Project proposes to use an applicator or infuser instead of an external application.

Injecting whole blood into cows will involve the same legal issues as do apply to the injecting of antigens into a cow regarding federal and state laws for biologics except for the following dilemma:

Since the whole blood is being put into an animal in order to stimulate the animal to have an increase immune production, it might be considered an animal biologic, because it is “intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response.” , If this is the case, then it will be similar to an antigen regulated by VSTA interstate and intrastate and practicing under an exemption will be necessary. However if a person takes the view that human blood fits within the definition of a human biologics, “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” then the blood would be under the FDA and jurisdiction. However if this is the case the following discussion will be relevant.

One element of the use of whole blood is different than the use of an antigen vaccine; namely, with whole blood there is no duplication of product; a person takes their own blood and develops a customized product for themselves. As compared to the use of an antigen where the product would not be customized to the exact person but rather would be antigen specific and given to a number of persons suspected of lymes disease. Comments regarding the whole blood type of situation are described in a legal memorandum prepared in 1982 under contract for the Office of Technology Assessment by Schwartz and Burke entitled “Legal Constraints on the Availabilty of Unorthodox Cancer Treatments: Consumer Protection View”. In part it reads as follows:

There is a difference between the Livingston-Wheeler method and the whole blood colostrum project in that the colostrum project requires the use of an intermediary step; namely the cow. It may be that the government would not have jurisdiction over the colostrum itself since it was made from a person’s own body fluid and not sold in the market-place. However the injection of blood into an animal may trigger VSTA and necessitate the use of the exemptions.

Regarding other areas of law, the same legal issues will apply to whole blood as do apply to the injecting of antigens into the cow; i.e.; Minnesota Veterinary use and standards, reporting statutes, and cruelty to animals. Regarding veterinary care with whole blood, if a veterinarian performs the procedure, then they will have to be within the parameters of the practice act for standard of care. If a person owns the cow and chooses to inject the natural substance of blood without a veterinarian’s help, then that person may be vulnerable to charges of “practicing veterinary medicine without a license”, or “cruelty to animals” if the process negatively affects an animal’s well-being.

The Project’s use of colostrum is much different legally than that of the blood and antigens because it is the product of the cow rather than the substance used to inject into the cow. Also the intended use appears to be for treatment of human illness as opposed to affecting the biology of the cow.

Substance law indicates that colostrum might be considered a “new drug” under federal law because of its intended use. It will also fall under the state definition of “drug” because of its intended use. If not adulterated or misbranded, the federal government would not have jurisdiction over it as a “new drug” unless it was going to be placed in interstate commerce.
However, the state may have jurisdiction over the produced colostrum as a “drug”, and the state may demand that it abides by FDA guidelines and regulation according to state law.

Minnesota Drug Law requires compliance with federal regulations and reads as follows:

If the colostrom substance in The Project is going to have a clearly intended use for external and internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease then the Minnesota state “drug” category may apply. In Minnesota the law states:

and Minnesota Drug law also gives exceptions to the law but refers to federal law when it says:

Given the intended use of the colostrum in The Project, the colsotrum would be potential candidate for needing to abide by “new drug” regulations. To avoid such regulation consideration of the following is relevant:

It may be that colostrum could qualify for the status of a “generally recognized as safe and effective” substance by federal and state governments. Under federal law a product is not a “new drug” within the meaning of the FDCA if its composition is such that it is “…generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling…” .

Or it may be considered to be outside of federal jurisdiction because it is analogous to the Livingston-Wheeler discussion in that it’s development is customized and produces a colostrum that is customized only for that person, in a sense, a safe oral customized vaccine. This argument of defense would not apply to colostrum produced after the injection of the antigen Borrelia burghdorfia and used for more than one patient.

Another approach is that dietary supplement jurisdiction might be sought. An introductory and preliminary stage of The Project might portray the customized colostrum without making health claims regarding specific disease but rather portray the colostrum as a customized dietary supplement, no claim of cure or treatment of disease, but rather as a healthful supplement, similar to other colostrum dietary supplement products on the market. This would require abiding by the dietary supplement health claim regulations.

State Health Care Practitioner Law

In addition to substance law, colostrum may be impacted by state health care practitioner laws. However unlike whole blood and antigens used by veterinarians or animal owners, the practitioner laws would be those relating to human health care practitioners. For example, in Saunders, the farmer was prosecuted for practicing medicine without a license. . At that time the Minnesota law read as follows:

Exemption to Medical Practice Act:

Since Saunders, and in the year 2000, the law of Minnesota changed and it now provides an exemption to the practice of medicine criminal charges as follows:

Minnesota Statute 146A is enforced by the Minnesota Department of Health out of the Office of Unlicensed Complementary and Alternative Health Care Practices and allows for unlicensed complementary and alterative health care practitioners to practice under certain conditions and with certain disclosures. Grounds for disciplinary actions are spelled out in the statute. The definition of complementary and alternative health care practices under the jurisdiction of the Department is as follows:

It appears that an unlicensed person abiding by Minnesota Statute 146A would have an opportunity to perform colostrum therapy and not be subject to charges of practicing medicine without a license. However that would depend on whether the Minnesota Department of Health had a complaint, which indicated fraud or an imminent risk of harm to the public or other grounds for disciplinary action.

This research was completed in order to inform proponents of the proposed Colostrum Therapy Project, of laws that may impact the feasibility of the Project. The Project notably involves three important substances: whole blood; Borrelia burghdorfia antigen; and colostrum. It also involves both animals and humans. Regarding humans, it involves both consumers and health care practitioners. The Project also involves federal and state law. The interface between all of these areas of law is very complex.

Review of substance law has assisted in identifying categories or classifications the substances of The Project might potentially fall under. The jurisdictional review has helped clarify jurisdiction over potential categories. Animal and veterinary laws indicate a need to abide by all state and federal laws regarding animal care and safety. State health care practitioner laws indicated a need to work with Veterinarians, Medical Doctors, Unlicensed complementary and Alternative Health Care practitioners, and other licensed providers within the scope of their licenses and within the proper standards of care or practice parameters. Given this research a preliminary risk assessment can be entertained for future discussion of feasibility.

Principles to follow in order to manage risk for this project.

1. Dietary Supplement status. Consider attaining your goal of helping persons with major illnesses without producing a new drug product that makes treatment or cure of a disease, or other health claims. If health claims are made, choose the category of dietary supplement, but follow all guidelines for dietary supplement regulation of health claims.

4. New Drug. If the Project has decided to make disease cures and treatment claims, then pursue a request from the FDA as to whether the category of colostrum would be exempt from new drug status because it is generally recognized as safe and effective. If so you will be able to proceed and still make claims.

2. Unapproved Antigen. Consider either using already licensed antigens or in the alternative, consider isolating an antigen within the state and using it under the exemption of Veterinarian or owner or obtain a license to use it directly from the state.

3. Research. Consider searching for research facilities in the state that contains access to a local IRB that would be interested in this type of a research project. Research under an IRB might be conducted as a dietary supplement project in general. Entry requirements into the clinical trials might be a positive diagnosis of Lymes disease or other illnesses and assessments might be general structure function or quality of life assessments.

5. State before federal. Before making any federal contact, consult with the State about the Project, describing it and obtaining advice of how to proceed within the law. Ie. Consult with the Minnesota Department of Agriculture and Board of Animal Health to get the go ahead and abide by their requirements for the use of an unapproved antigen. If this is accomplished it will be an important beginning.

6. Medical and Animal Health Team. Coordination of professionals familiar with the Department of Agriculture and professionals involved in Human Health will be key to this project. Developing a willing and working team of professionals to pursue further feasibility will be important.

7. Whole blood. Obtain approval from the state of the safe use of whole blood as an antigen in a cow at the same time you obtain permission to use lymes disease antigen. Consider ahead of time potential safety issues to the cow for example the danger imposed on a cow if it is injected with alcohol or chemotherapy drugs within a human blood sample. Regarding practice laws, obtain feedback from the Board of Chiropractic or the Board of Medical practice to access the standard of care issues regarding the taking of human blood and how to obtain a doctor’s order for phlebotomy. Unlicensed practitioners may not draw blood and this will be an important aspect to clarify.

8. Be upfront with legal authorities regarding the project and work with highly qualified individuals so that it does not run into legal vulnerability in the future. It is a complex project and will require an open-minded and assertive team that can convince authorities of its merit.

Sample Scenario:

1. The colostrum product will be produced as a dietary supplement and no claims of treating or curing a disease will be made and no unusual health claims will be made.
2. Borrelia burghdorfia antigen already licensed will be purchased and used for vaccination of cows or the state will provide approval to use an unapproved antigen isolated in Minnesota.
3. If exemption is necessary then use the federal exemptions of Veterinarian or owner.
4. State research facilities will participate in research, and human clinical trials will be set up under a state IRB for persons with entry requirement of positive diagnosis of Lymes disease to measure structure function changes.
5. Licensed Veterinarians or owner shall be used for all cow management.
6. Colostrum will be handled by Grade A and organic dairy operations.
7. Professional researchers and medical assessment teams will be used for follow up on symptoms, chart reading, and data collection of human subjects.
8. Human center will meet with requirements for medical care.
9. Persons properly licensed and authorized to draw blood will participate with humans.

Information Center

July 2003 - Colostrum Therapy Project,
Research Memorandum, Produced for Chapdelain

Information Center

July 2003 - Colostrum Therapy Project, Research Memorandum, Produced for Chapdelain

July 2003 - Colostrum Therapy Project,
Research Memorandum, Produced for Chapdelain