Frequently Asked Questions
Q: What is medical food?
A: The FDA has come to realize that foods do have health value beyond basic nutrition. The evidence is quite convincing. As a result, the category of “medical foods” was recently introduced. The statutory definition of a medical food can be found in the FDA's regulations at 21 CFR 101.9(j)(8).
If the CFR 101.9(j)(8) requirements are followed, a vendor is allowed to state and promote the healing effects. In contrast, herbal supplements are specifically prohibited from promoting healing effect.
FDA certification is still required before a medical food is introduced. But the medical food bar is SSA certification rather than formal FDA approval.
Q. Where does a medical food fit, relative to drugs and herbal supplements?
A. Roughly, in the middle. It's a food rather than a drug. But it's legal to discuss the healing properties.
Q. Is this a new market?
A: Yes. This is a ground-floor opportunity.
This market is in its infancy. The guidance documents were released in August and September 2013. The “medical foods” category allows (actually, requires) the vendor to state the health effects. For the first time, websites can state the benefit of a food compound. Brochures can say it. Salesmen can talk about it. In turn, the medical food has to meet some definitional requirements, which our Glutrasol products can meet.
Q. Can people buy medical foods and self-medicate?
A. No. A fundamental understanding is that the medical food must be supervised by a doctor, nutritionist, or similar professional. The guidelines on “professional” are still in flux. But specifically, Glutrasol cannot be sold directly to consumers through a website for personal use.
Glutrasol must be sold through a health care professional.
Q. Is a prescription required to purchase a medical food?
A. No. But it must be used under professional supervision.
Q. Does FDA evaluate and certify medical foods?
A. Yes. But a medical food doesn’t require formal FDA approval (like pharmaceutical drugs). Formal FDA approval is extremely expensive. The FDA recognized that useful medical foods would not be brought to market if formal FDA approval were required. Approval costs could exceed potential profits.
Whereas “FDA approval” requires many years and tens of millions of dollars, the approval of a medical food requires far less. Clinical studies are still needed, and investment dollars are needed to accomplish this initial phase. But the standard here is the SSA (Substantial Scientific Agreement) rather than FDA Approval.
SSA is a basically good analytical practice. Sampling should be random; test and control groups are needed; conclusions must fit the data; etc.
Q. Can animal studies be used for FDA certification?
A. FDA does not accept animal data as conclusive of human data. Animal data can (and should) be referenced. But it won’t carry the day.
Q. Can the SSA testing use chemical markers?
A. SSA does allow the use of chemical markers if the literature supports a correlation between the chemical marker and disease symptoms.
Q. What chemical marker is most pertinent to Glutrasol?
A. Cortisol. Cortisol is the major stress hormone. Chronically high levels are the problem. Persistently high cortisol correlates with human infertility,diabetes, heart disease, sleep disorders, depression and breast cancer (among others). Cortisol control with Glutrasol resolves (or helps resolve) these problems.
Q. Have you tested Glutrasol?
A. Yes, but only in animal studies. Many of the same compounds that make up Glutrasol have been prescribed by veterinarians to treat many diseases in animals. The success of animal treatments has been well documented, and we are confident that human results will be the same.
Q. What are examples of successful Glutrasol animal interventions?
A. Cattle fertility increased dramatically. Horses with Cushings Syndrome (diagnosed by high cortisol) improved. Livestock morbidity dropped. Livestock weight increased without using antibiotics. This was a small sampling.
The range of animal testing includes birds, sheep, horses, cattle, goats, dogs, cats and pigs.
Q. Why are you confident that animal and human results will be the same?
A. All mammals have the same cortisol production mechanism. Monkeys, cows, pigs, goats, sheep, dogs, cats, and humans are the same from the cortisol perspective.
Specifically, the hypothalamus releases corticotropin releasing hormone, which causes the anterior pituitary gland to secrete adrenocorticotropic hormone (ACTH). Adrenocorticotropic hormone travels to the adrenal cortex, which responds by producing cortisol. Levels of cortisol are controlled by negative hormone feedback loops.
Q: How do you plan to sell the Glutrasol products?
A: This is a rather different model than a standard start-up company because CortControl is a product development and intellectual property company. First, we develop medical food formulations based on our existing dominant patents and patent applications. Second, we secure method-of-use patents to further provide a “picket fence” of IP protection. Third, we develop the brand, establish trademarks, and perform SSA tests for FDA certification. At this point, we have a complete package to sell because all the medical food fundamentals are in place. The exit step is to sell our brand to manufacturers/distributors, which can enter a highly profitable market without delay.
Q. Does the manufacturer/distributor have to undergo FDA drug audits?
A. No. FDA oversight will be limited to food audits.
After the SSA tests are accepted to demonstrate the drug effect, the medical foods are considered foods, not drugs.
Q. What is CortControl’s revenue stream?
A. Our revenue comes from the initial sale of each compound license, plus a royalty from every unit sold by the distributor.
CortControl’s licensee will make the product, create the packaging and perform the sales and distribution to the licensed medical groups that prescribe it to the patient for treatment.
Q: What is the expected time for SSA testing?
A: Our SSA testing is estimated to take 6-8 months (we do have a complete detailed SSA study procedure for our first indication, Glutrasol IF for infertility). Please contact us for more information.
Q: Why are the foods effective with each of the diseases you will treat?
A: We are focused on one chemical marker, Cortisol. Cortisol is called a “Stress” hormone and affects the immune system. Cortisol can diminish the effectiveness of our body’s ability to fight disease. If we control the Cortisol levels in patients that have diseases with indications for high Cortisol, we can help their immune system fight their disease.
Research studies have demonstrated a connection between high cortisol and each of our six initial target areas. Some correlations are dramatic. For example, one cardiovascular study concluded that high cortisol is a better predictor of heart attacks than either high cholesterol or high blood pressure.
Recently, there has been quite a bit of press correlating stress to infertility.
Q: How do you know that the taste will be acceptable to humans?
A: We have developed the Glutrasol compounds in powder form so they can be blended into smoothies, juice blends, soups etc. We have worked with a taste testing lab to develop flavor that will be attractive to human taste. We also have capsules that can be taken orally.
Q. Has CortControl chosen the initial market focus area?
A: Yes. It is infertility. A specific infertility SSA procedure has already been written and approved. A method-of-use patent application (specific to infertility) was filed March 29, 2014.U.S. Patent Application No. 14/640,457; Our Ref: 128247-219292 (P003) Infertility . . . US Patent 9,463,218 B2