Welcome to Homeopathy
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 DilutionsThe 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.
Comparison of Homeopathic Medicine vs. Dietary Supplements, Drugs and PharmaceuticalsAlthough 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.
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.
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|
FDCA: Homeopathic Medicine
DSHEA: Dietary Supplements
Every homeopathic medicine must be listed with the FDA and receive its own NDC number.
Every pharmaceutical drug must be listed with the FDA and receive its own NDC number.
Dietary supplements are not required to be listed with the FDA.
In 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.
Effectiveness 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.
Dietary supplements cannot legally claim to diagnose, mitigate, treat, cure, or prevent any disease.
Our 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.
Established through clinical trials performed by the manufacturer.
Due to US patent law and other factors, most drugs are not derived from natural sources.
Ingredients may not have been monographed or safety tested.
|Safe for All Ages|
Our homeopathic medicine has been safely used by over one million babies.
While simethicone is generally considered safe, the FDA does not recommend use of reflux drugs for children under 2 years of age.
No age safety standards exist for dietary supplements because ingredient testing is not required.
|FDA Mandates Compliance with Good Manufacturing Practices (GMPs)|
Homeopathic medicine must comply with GMP manufacturing standards for medicines in an FDA inspected facility.
Drugs and pharmaceuticals must comply with GMP standards in an FDA inspected facility.
Dietary supplements can be made legally in someone’s kitchen. GMPs are only “proposed.”
|Free of Side Effects|
According 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.
Reflux drugs have numerous documented side effects including weakened bones, vitamin deficiency, reduced immune function, increased risk of stomach infections to name a few.
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|
According to the principles of homeopathy,stimulates the body’s self-healing properties as opposed to suppressing symptoms.
Reflux drugs inhibit stomach acid production thus interfering with the natural digestive process.
Many 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|
Apply only upon onset of symptoms.
Both anti-reflux and anti-gas drugs require regular dosing.
Apply only upon onset of symptoms.