The time of robots is over.
We have achieved a new level between people and technology.
People and machines are finally united as one single being.
We improved ourselves until we lost control of our own nature. —iRobot2 trailer(2025)
Food, Drug, Cosmetic Act Amended
On January 7, 2025, Arizona Representative, David Schweikert (R), introduced H.R. 238: To amend the Federal Food, Drug, and Cosmetic Act:
H.R.238 – To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administration, and for other purposes.
The Food, Drug, and Cosmetic Act (FD&C Act (21 U.S.C. 321(g))), was enacted in 1939, sponsored and co-authored by New York senator, Royal Copeland, who was also a homeopathic doctor.
In the early 1900s, when medical physicians worked side by side with homeopathic physicians, Dr. Copeland added a provision to the law recognizing the Homeopathic Pharmacopoeia of the United States (HPUS), alongside its counterparts, the U.S. Pharmacopeia (USP) and the National Formulary (NF).
[Note: The HPUS is the official guide of homeopathy that contains information and manufacturing standards for over 1,300 official homeopathic substances.]History of Homeopathic “Drugs”
Homeopathic remedies are considered “drugs,”per section 201(g)(1) of the FD&C Act.
Whether it was right or wrong to legally confine homeopathy to drug status, it has allowed homeopathic remedies to be mass manufactured and widely distributed as over the-counter (OTC) products.
Homeopathy escaped full FDA drug enforcement because the Agency had placed homeopathic drug products in a separate category and deferred consideration of them. They did not review any homeopathic drug products under the OTC Drug Review process of 1972 because of their innocuous nature.
In 1988, the FDA employed risk-based enforcement approach with respect to the manufacturing, distribution and marketing of homeopathic drug products. Compliance Policy Guide (CPG) issued at 400.400 clarifies “Conditions Under Which Homeopathic Drugs May be Marketed.” In 2015, FDA investigated homeopathy realizing its tremendous market growth. In 2018, new draft guidance focused regulation of certain homeopathic products because “some products labeled as homeopathic are marketed to treat serious diseases or conditions.” With each new potential encroachment, the reason for investigation appeared arbitrary.
As of 2022, provisions of the CARES Act (Public Law 116-136 (March 27, 2020), do not include GRAS/E (generally regarded as safe) determinations for homeopathic products under section 505G. Nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements.
This means the FDA can decide to regulate homeopathy as any other drug anytime it chooses.
What Is Homeopathy?
(skip over this section if you already have an idea).
Homeopathy is an ‘alternative medicine,’ providing customized treatment. Founded in 1796 by German physician Samuel Hahnemann, it was first systematized based on two principles: (1) The Law of Similars, i.e., like-cures-like”; and (2) The Law of Infinitesimals; the more diluted the substance, the more potent it is.
Because of its holistic nature, homeopathy has been used by lay people for centuries, and called, The People’s Medicine. In the 1800s, homeopathy was considered safer than blood-letting and purging. In 1903, the American Medical Association invited homeopaths to join the organization after long-held antagonism.
Homeopathic medicines are established through “provings;’ when a substance is shown to cause symptoms in a healthy person. The substance is ‘potentized‘ (via succussion) and highly diluted (e.g., 10X, 20X), before being used to treat those symptoms in a sick person. As a homeopathic medicine, the diluted, potentized solution, consisting mainly of water molecules, retains therapeutic properties due to a “memory” of the substance diluted in it.
Because homeopathy is so highly diluted, to contain only the memory of a substance, it falls into an exclusionary zone of enforcement. It slips through the cracks of a materialist system.
On the other hand, because homeopathy cannot be measured and quantified as synthetic drugs are, it has been ripe for scrutiny by conventional scientists who have had to endure the expensive and time-consuming risk assessment process for their toxic pharmaceutical drugs.
Some scientists rightly claim that homeopathy cannot be measured by conventional means, then attempt to prove their point through conventional science. Alternatively, some scientists claim that homeopathic drug products without an active ingredient cannot be an effective treatment, but it can be harmful and dangerous to patients. What is the truth? It cannot be both at once. Is homeopathy dangerous or not? What about evidence showing it benefits cancer and ‘Covid-19?‘
It is not appropriate to compare homeopathy (specific to the individual) to allopathy (one-size fits all). A lack of knowledge about homeopathy among allopathic doctors could be remedied by researching one of the many homeopathic research databases.
As the arguments go back and forth, time is running out. A new system of A.I. and Telemedicine seeks to bury homeopathy and holistic medicine once and for all.
Innovation & A.I.
With A.I. digital medicine coming online for “innovation,” safety studies may be a thing of the past for all drugs. Soon the Personal Digital Twin will prevent the need for long-term toxicological drug studies that once touted “safety and efficacy.” The calls for any drug studies will be moot.
According to Arizona Rep. Schweikert’s website, “innovation is being incentivized” through new legislation. From H.R. 7827 (vaccines as substance therapy), to H.R. 297, (TeleHealth digital home testing), a new Age is coming faster than we can measure it.
How does holistic medicine, such as Homeopathy, fit into “machine learning?”
If Homeopathy has survived since the late 1700s, it stands a good chance of surviving into the future. But it must be protected by people as “the people’s medicine,” even if driven underground for a time.
A.I. has made its entrance. It is not going away. While we continue to use Homeopathy as a safe medicine, it is always a good time to question the unproven safety and equity of AI innovation.
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