Homeopathic remedies are often mistaken for herbals or dietary supplements, but, in fact, they are medicine. Quite remarkable ones indeed.Homeopathy is a natural medical system discovered two centuries ago by German physician and chemist, Samuel Hahnemann. The fundamental theory of homeopathy is based on similia similibus curentur (“like shall be cured by like”) and uses active organic medicinal substances at varying concentrations.

How are Homeopathics Made?

Homeopathic medicines are manufactured using precise pharmaceutical methods in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS). Unlike herbals and dietary supplements, homeopathic medicine manufacturing must comply with the Good Manufacturing Practices (GMP) for over-the-counter pharmaceuticals. Each homeopathic medicine is obtained from a precise and controlled process of successive homeopathic “dilutions”. According to homeopathy, this process attenuates the original organic solution and transforms it into a therapeutically active medicine. Sometimes the original remedy is present in visible amounts and sometimes in micro-doses. Colic Calm and Tummy Calm combine visible amounts of activated carbon in the form of Carbo Vegetabilis 1X (hence the black color) with small doses of traditional botanical remedies for digestive discomfort.

Homeopathic Dilutions

The homeopathic ingredients in Colic Calm are diluted either to 1X, 3X or 5X potency. A 1X dilution is obtained by mixing 1 part of the medicinal ingredient with 9 parts of a neutral diluting agent then vigorously shaking the solution (succussion). The 3X is obtained by repeating this dilution and succussion process 3 times. Eight of the nine active ingredients in Colic Calm operate according to homeopathic principles at a 3X or 5X. 3X potency is 1 part per 1,000, or 0.1%. A 5X potency is 1 part per 100,000 or 0.001%. Dilution is not uncommon in many non-homeopathic pharmaceuticals in use today. For example, drugs such as, Ergocalciferol, are much more diluted than 1 part per 1,000. However, unlike most drugs, homeopathic products are not subject to pre-market approval by the Food and Drug Administration (FDA) and are not reviewed by the FDA. The FDA has not evaluated this product.

How Safe are Homeopathic Medicines?

For 200 years, homeopathy has safely treated a wide array of illnesses and injuries physical, mental, and emotional. In the USA, homeopathic medicines must be registered with the FDA and must be made in accordance with Good Manufacturing Practices (GMP) standards for over-the-counter (OTC) medicines in an FDA inspected facility.Most homeopathic medicines are extremely safe, carrying no risk of side effects, and are non-addictive. Even if one takes the wrong remedy for the wrong condition, it will do no harm. This makes most homeopathic remedies especially well-suited for babies and the elderly. Because of their inherent safety, they are frequently used for the treatment of self-diagnosable conditions. They provide a natural and affordable alternative to over-the-counter conventional drugs.

Comparison of Homeopathic Medicine vs. Dietary Supplements, Drugs and Pharmaceuticals

Although homeopathy is not without controversy, a great number of scientific and clinical studies have been conducted, with more than 150 published in prominent medical journals worldwide. For many parents, homeopathic medicine is their first choice for treating children due to the long safety record and absence of side effects. Most homeopathic medicines are made from natural ingredients having a safety track record as old as 200 years or more, and are documented in the Homeopathic Pharmacopeia of the United States (HPUS) and supporting Materia Medica. Our products also follow the manufacturing and quality practices outlined in the Homeopathic Pharmacopoeia of the United States. To learn more about homeopathy visit the National Center for Homeopathy’s website.On the other hand, dietary supplements and herbals are manufactured under less stringent DSHEA guidelines. Proposed Good Manufacturing Practices (GMP) are voluntary.In this context, the following table offers a brief comparison of popular remedies for colic, gas and reflux.

Colic Calm Homeopathic Medicine

Synthetic Drugs and Pharmaceuticals

Includes Reflux Drugs (Proton Pump Inhibitors and H2 Antagonists), Anti-Gas Drugs (Simethicone)

Regular Gripe Waters

FDA Regulatory Status
FDA Listed
YesEvery homeopathic medicine must be listed with the FDA and receive its own NDC number.
YesEvery pharmaceutical drug must be listed with the FDA and receive its own NDC number.
No Dietary supplements are not required to be listed with the FDA.
Symptom Effectiveness
YesIn the US, the FDA does not typically review, evaluate or approve any homeopathic medicines. However, our ingredients comply with the Homeopathic Pharmacopeia of the United States (HPUS), and are monographed in supporting homeopathic materia medica.
YesEffectiveness established through clinical trials performed by the manufacturer or 3rd parties. Most pharmaceuticals undergo an approval process with the FDA. The regularly scheme for drugs is different from that of homeopathic medicines.
No Dietary supplements cannot legally claim to diagnose, mitigate, treat, cure, or prevent any disease.
Overall Safety
YesOur ingredients are monographed in the HPUS and have a long history of safe use in medicines and foods. Our ingredients are listed on the FDA’s Generally Recognized As Safe (GRAS) list.
All of our active ingredients are derived from natural sources.
YesEstablished through clinical trials performed by the manufacturer.
Due to US patent law and other factors, most drugs are not derived from natural sources.
No Ingredients may not have been monographed or safety tested.
Safe for All Ages
YesOur homeopathic medicine has been safely used by over one million babies.
No While simethicone is generally considered safe, the FDA does not recommend use of reflux drugs for children under 2 years of age.
No No age safety standards exist for dietary supplements because ingredient testing is not required.
FDA Mandates Compliance with Good Manufacturing Practices (GMPs)
YesHomeopathic medicine must comply with GMP manufacturing standards for medicines in an FDA inspected facility.
YesDrugs and pharmaceuticals must comply with GMP standards in an FDA inspected facility.
No Dietary supplements can be made legally in someone’s kitchen. GMPs are only “proposed.”
Free of Side Effects
YesAccording to the principles of homeopathy, the body uses what it needs for self-healing but the wrong remedy will cause no harm. Colic Calm has been used safely by over 1 million babies.
NoReflux drugs have numerous documented side effects including weakened bones, vitamin deficiency, reduced immune function, increased risk of stomach infections to name a few.
No Because testing is not required, the side effects of many dietary supplements are unknown. However, a dietary supplement gripe water brand was subject to a major recall due to bacterial contamination.
Promotes Natural Function Without Altering Body Chemistry
YesAccording to the principles of homeopathy,stimulates the body’s self-healing properties as opposed to suppressing symptoms.
NoReflux drugs inhibit stomach acid production thus interfering with the natural digestive process.
NoMany gripe water brands contain sodium bicarbonate, an alkali which inhibits natural stomach acidity and interferes with the absorption of nutrients such as folic acid and iron.
Use Only As Needed
Yes Apply only upon onset of symptoms.
NoBoth anti-reflux and anti-gas drugs require regular dosing.
YesApply only upon onset of symptoms.
Disclaimer: The above represents our interpretation of the applicable laws and regulations governing drugs and supplements in the United States and is not a legal opinion. If you have any queries concerning the regulatory status of any products, including homeopathic products, you should consult the FDA’s website.

Homeopathy in the World

According to the World Health Organization, homeopathy is the second largest primary health care system in the world.  In Europe, over 100 million people use it on a regular basis (over 30 percent).  In France, over one third of family doctors prescribe homeopathic remedies, and there are several schools, outpatient clinics and even homeopathic hospitals.  England also has several homeopathic hospitals and it is the chosen medical treatment of the Royal Family and part of the national health system.  In Germany, 25% of physicians turn first and foremost to homeopathy.  In India, there are over 100 homeopathic medical schools and many government-funded homeopathic hospitals.In the United States, Homeopathy’s popularity is steadily growing. In fact, in the early 1900s, the most prestigious medical  schools in this country were homeopathic. The medical schools converted to allopathic medicine as fast-acting synthetic drugs were developed. Few knew then of the inherent dangerous side effects of pharmaceutical drugs.  Today, homeopathy is becoming increasingly favored once again, due to mounting evidence regarding the risks of drug toxicity and its effect on health. Fortunately, the safety and efficacy of natural homeopathic medicines are resulting in more widespread use and acceptance.People are returning to homeopathy because they understand that, in order to become truly healthy, one must treat the root cause of illness and not just the symptoms. Many Americans feel that pharmaceutical drugs often interfere with the body’s natural ability to heal itself. Suppressing, or merely removing symptoms, is a temporary solution at best.  Addressing the “whole” person naturally is a long-term solution to modern states of illness.  This is exactly what homeopathy does so safely and effectively.

Why is Colic Calm Homeopathic?

Babies are born with immature digestive and nervous systems. It can take several months for their digestive tracts to learn to function properly and for newborns to develop self-soothing abilities.  Colic Calm actually treats the source of discomfort during the growth period, not just the symptoms.  Colic Calm homeopathic medicine has the unique ability to support and accelerate the natural healing processes of the body. Unlike other formulas that can wreak havoc on delicate pH and electrolyte balances and lead to side effects and further complications, Colic Calm alone respects and strengthens the proper internal harmony of the body.