Firstly who are the FDA and what do they do?
The acronym FDA stands for the Food and Drug Administration. It is an agency that functions within the Department of Health and Human Services. Quite briefly the job of this agency is to assure that the public receives safe and effective drugs, food products, cosmetics and health products. They are also involved in improving health technology through providing science-accurate and up to date information to the public.
SinusWars is a company that sells natural homeopathic remedies. There are strict rules and regulations from the FDA that allow SinusWars to manufacture these products so that they can be sold.
You can find full information on these regulations under CPG Sec. 400.400 on the FDA website.
The document states that the FDA recognizes all drugs and standards found in the Homeopathic Pharmacopeia of the United States (HPUS), in the United States Pharmacopeia (USP), the official National Formulary (NF) and in other additions to this. This means that only homeopathic medicine from these Homeopathic Pharmacopeia’s can be used.
There are other regulations set forth by the FDA. These include that all homeopathic medicine must in general meet the standards for strength, quality, potencies, dosing, purity and other parameters set forth in the Homeopathic Pharmacopeia and in various approved Materia Medica’s.
The FDA states that it should be noted that even if a product falls in line with all the above regulations it does not declare that this product has been shown by suitable means to be safe, effective and that it has not been misbranded for its intended use.
There are also labeling conditions that every homeopathic medication should include on its product such as the name of the product and it’s potency, the address and identity of the company, directions of use, indications for use (OTC), ingredients, warnings (OTC), a declaration of net quantity of contents, a statement of dosage, the address and name of the manufacturer/packer/distributor and even the language to use. If the product is too small to accommodate all this information, a leaflet should be provided.
Firms which produce, prepare, mix and process homeopathic drugs must be registered as a drug establishment according to FDA standards (section 510; act 21 CFR 207) while passing all the above requirements.
Expiration dates and testing for release and distribution requirements are not needed for homeopathic medicine.
So…… Are SinusWars Remedies FDA Approved?
The FDA does not approve any companies or laboratories but rather every facility that manufactures homeopathic products should be certified by the FDA which then indicates that the facility has met certain standards which would allow them to produce safe and effective homeopathic medicine.
All SinusWars remedies are manufactured in an FDA certified and registered licensed facility which ensures that all our products are made with the highest standards and quality.
Every SinusWars product has its own NDC number as well. The acronym NDC stands for National Drug Code. This code is placed in a universal directory that’s serves to identify all human drugs.
The NDC number is made up of a 3 segment number that can be used to identify the product. The FDA inputs the full NDC number and the information submitted for the products into a database called the Drug Registration and Listing System (DRLS) or eDRLS for the electronic version. All this information is then made available to you by means of the National Drug Code Directory.
For more information about the FDA please visit their website here
All the best,