How the FDA Processes & Regulates Medications

For a medication or supplement to be sold in the U.S., it must meet certain Food and Drug Administration (FDA) requirements to prove the product is safe and effective. This entails submitting documents to the FDA that back up the product’s claims and detailing clinical studies that have taken place. If no such clinical trials exist, a product must be clearly labeled with specific disclaimers.  Oftentimes, people think that obtaining FDA approval makes a product risk-free and completely safe to use, but this is not always the case. Explore what the FDA is responsible for, what manufacturers must do to obtain FDA approval, and why homeopathic medications meet different requirements with the FDA.

What is the FDA Responsible for?

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, vaccines, biological products, medical devices, food, and cosmetics.1 Along with evaluating drugs and medical devices before they may be offered for sale, the FDA also categorizes a medication as prescription or non-prescription based on the evaluation of the ingredients. Even more, the FDA plays a significant role in establishing standards for usage and for distribution of information and labeling. When a product has proved to be faulty in some way, the FDA issues recalls when necessary to further protect the public health.

What Does it Mean to Be an FDA-Approved Drug?

Both prescription and non-prescription medications must be proven safe and effective to FDA’s satisfaction before companies are allowed to sell them to the public. However, it is important to note that the FDA does not take part in conducting safety and efficacy tests themselves. The agency’s role is to review the results of laboratory, animal, and human clinical testing completed by manufacturers. FDA approval is mandatory for drugs that might pose a significant risk of injury or illness, but can also benefit your health. When a drug has received FDA approval, it means that the benefits of the drug outweigh the risks for the intended population. It does not mean there are no known harmful side effects. Common reactions associated with FDA-approved antiviral medications used to treat the flu, for instance, include nausea, vomiting, and diarrhea.2 Guaifenesin, an FDA-approved expectorant found in popular cold and flu medications Tylenol Flu and Mucinex, is associated with dizziness, drowsiness, stomach pain, headache and rash.3 

How Do Medications Become FDA Approved?

There are several steps a manufacturer must take to obtain FDA approval.5 These include:
  • Step 1: FDA reviewers analyze the current treatment landscape in order to properly weigh the drug’s risks and benefits. If benefits outweigh the risks, especially for life-threatening conditions, then the approval process continues.
  • Step 2: FDA reviewers then evaluate clinical benefit and risk information that has been submitted by the drug maker, taking into account any uncertainties that may result from incomplete data. Though two clinical trials are preferred, sometimes one clinical trial is sufficient if an illness is rare and multiple trials are not possible.
  • Step 3: According to the FDA, all drugs have risks. These risks and management strategies are gathered at this point to be clearly indicated on the drug’s label.

Can Homeopathic Medications Be FDA Approved? 

Homeopathic products like Brillia Health are regulated differently than other drug products. According to FDA regulations, homeopathic medications must support their health claims with substantive documentation detailing clinical trials and studies, abide by FDA standards and regulations, and undergo a proper registration process breaking down active ingredients and inactive ingredients in order to be allowed to be sold in the U.S. If evidence is inconclusive or no such clinical trials have taken place, this must be stated clearly on the label. Most people will have seen on homeopathic labels and supplements the disclaimer that “There is no scientific evidence that the product works.” This means that the product’s claims are based only on theories of homeopathy from hundreds of years ago that are not accepted by most modern medical experts.    
1
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Brillia Health takes the extra step in providing the FDA with documented scientific evidence and clinical studies to support each of its claims. When a new shipment of medication arrives, there is a thorough review process completed on a sample from the shipment and the boxes will not be sold until FDA clearance has been earned. 

The Benefits of Homeopathic Medications

Homeopathic medication aims to work with your body by helping it heal itself, unlike other medications that attempt to suppress the body's natural response to illness through symptoms like fluid secretion and inflammation. While some people equate homeopathy with folk healing, Brillia Health believes in combining tradition with a scientific approach. The result is a gentle product with active ingredients that target illness at the source without causing harsh or harmful side effects.  Brillia Health products contain targeted antibodies, which are highly specific molecules that attach to proteins the body releases when we get sick, gently and effectively stopping the instigation of cold and flu symptoms altogether. Both products, Cold-Flu Recovery and Cough Control, are designed to reduce cold, flu, and cough severity as well as shorten the duration of illness as verified in numerous clinical studies while letting your immune system recover faster.  
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Knowing the risks associated with FDA-approved medications will help you make an informed choice the next time you catch a cold or flu. Find out more about how Brillia Health products work and visit our blog to find more resources on how to stay healthy all year long. Erica Garza is an author and essayist from Los Angeles. She holds an MFA from Columbia University and a certificate in Narrative Therapy. Her writing has appeared in TIME, Health, Glamour, Good Housekeeping, Women's Health, and VICE.
References: 1https://www.fda.gov/about-fda/what-we-do, 2https://www.cdc.gov/flu/treatment/whatyoushould.htm, 3https://www.rxlist.com/consumer_guaifenesin_mucinex/drugs-condition.htm, 4https://www.fda.gov/drugs/development-approval-process-drugs

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