Approved by the FDA or Not?

If you have seen the phrase “FDA Approved” on a company website or commercial where a treatment or product is being marketed, you may automatically trust the said product. The question here, though, is how can you be sure that the FDA has indeed given their stamp of approval?

The U.S. Food and Drug Administration (FDA) regulates everything from food and tobacco products to medical devices and animal drugs to ensure that what manufacturers put on the market is safe for the public.

What you need to be aware of, though, is that not every product is granted premarket approval, which means it may become available for sale before being approved by the FDA. In some cases, the FDA is forced to go after companies that release products prior to approval. The U.S. Congress has long since granted the FDA the authority to act when they see that a company has put out products or treatments that may be considered a health risk to the general public.

Let’s take a moment to look at the FDA regulation process, as well as finding out the things that they do not approve.

Companies Are Not Approved by the FDA

Manufacturers, laboratories, and healthcare facilities are not approved by the FDA. That said, the FDA is well within their right to inspect these types of facilities to ensure that they use acceptable manufacturing regulations.

Unless some sort of exemption is in place, domestic and foreign food and drug operators are required to register their facilities with the FDA. The same rules apply to blood and tissue facilities.

Mammography facilities are required to have FDA certification, and their certificate needs to be clearly on display for patients. The certificate lets patients know that the facility has met or exceeded the strict health regulations that the FDA have in place.

New Drugs and Biologics are Approved by the FDA

All new drugs, as well as certain biologics, need to receive FDA approval before a company can take them to market. The biologics that usually require FDA approval include vaccines, blood and blood products, cellular therapies, and therapeutic proteins. In order to be granted approval, manufacturers need to be able to show that their products can be produced in adherence to federal quality standards.

The FDA does not actually test or develop products prior to approval. What they do instead is look at lab, animal, and human testing results performed by the manufacturer. The FDA will grant approval to a product if they deem it to have more benefits than known risks when used as directed.

Compounded Drugs Are Not Approved by the FDA

Pharmacists or doctors will sometimes combine ingredients to create new medications that meet the specific needs of individual patients. This is referred to as compounding and is a practice that is also used to deliver meds to patients who may be allergic to certain FDA-approved drugs. The FDA does not approve compounded drugs, so patients need to be aware that the effectiveness, safety, and quality of those drugs cannot be verified.

 

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The Best Home Remedies for Chronic Bronchitis

Bronchitis is a common respiratory disease caused by viruses, bacteria, irritants such as smoke, and other particles that aggravate the bronchial tubes. These tubes bring air from the nose and mouth to the lungs.

Home remedies are actually your best bet when it comes to treating chronic bronchitis. Research trials have shown that antibiotics are not effective for the treatment of chronic bronchitis. Despite evidence of ineffectiveness and clear guidelines in the medical world, the prescribing rate for chronic bronchitis has actually risen.

Best home remedies for chronic bronchitis

  • N-acetyl cysteine (NAC), a form of the amino acid cysteine, helps thin and loosen mucus. Take one 600-milligram dose three times daily, between meals, until the chronic bronchitis has cleared up.
  • Echinacea and astragalus are herbs that strengthen the immune system and help you fight off bacteria and viruses. Take 500 milligrams of either herb four times a day for acute bronchitis or twice daily for chronic bronchitis.
  • R-lipoic acid is a powerful antioxidant nutrient that is vital in the repair of inflamed airways. Like other antioxidants such as vitamins E and C, R-lipoic acid contributes to your health by counteracting the effects of harmful molecules called free radicals, which damage cells.
  • A medicinal formula called Arcozon has potent antibacterial and immune-stimulating properties. It contains four herbs that have been traditionally used by healers in the Amazon rainforest: uña de gato (cat’s claw), pau d’arco, suma, and jatoba. You can use it to prevent or treat bronchial infections. Take one teaspoon or four capsules four times daily for short-lived bronchitis or twice daily for chronic bronchitis.
  • Ginger. Some researchers have found evidence that ginger can have an anti-inflammatory effect against respiratory infection.
  • Garlic is said to have countless healing properties. Results of a 2016 study show that garlic effectively inhibited the growth of infectious bronchitis virus. This finding suggests garlic can be used as a natural remedy for chronic bronchitis.
  • Turmeric is a spice often used in East Indian foods. A 2011 study found turmeric provided more anti-inflammatory effects than ginger. Turmeric also increases antioxidant activity. That means it may help reduce irritation and boost your immunity.

A healthy lifestyle goes hand in hand with the prevention of illnesses. It can help you recover faster when you’re sick, too. A minor illness may even be your body’s way of telling you to slow down and take it easy.

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Folic Acid and How It Might Prevent Birth Defects

Latina’s who are pregnant may be missing a key ingredient in their diet that is believed to play a role in preventing certain birth defects.

The ingredient in question folic acid, which has been used for some time in the fortification and strengthening of several enriched grains.

Jonca Bull, M.D., director of the U.S. Food and Drug Administration’s (FDA) Office of Minority Health believes that Hispanic women do not get the folic acid they need from cereal grains, as those are not usually part of their diet. Hispanic women generally lean more towards corn masa-based foods in their diet.

This may explain why among US women, it is Latinas who are most at risk of giving birth to children with neural tube defects (NTD’s). This information comes from the Centers for Disease Control and Prevention (CDC), who explain NTD birth defects as those that affect the brain, spine, and spinal cord. These include anencephaly and spina bifida.

The FDA are going out of their way to help Latinas and their children by approving the addition of folic acid to corn masa flour. This is the type of flour commonly found in foods like tortilla chips, tacos, tamales, and tortillas, which are considered staple foods of the Hispanic population.

Women who consume folic acid, which is a B vitamin, before and during pregnancy may reduce their risk of neural tube defects.

Masa, which is the Spanish word for flour, is created by cooking corn in a bitter tasting alkali and the grinding it down into flour.

The Importance of Prevention

Back in 1988, the CDC and the U.S. Public Health Service recommended that pregnant women get more folic acid, and the FDA listened. The FDA required folic acid to be added to standardized enriched cereal grains, such as rice and flour. They also required that it be added to standardized enriched cereal grain products like enriched bread and macaroni.

The addition to B vitamins to refined grains after processing makes them more enriched. Standardized foods must contain FDA approved ingredients, and they are produced in very specific ways.

A total of 5 organizations – the March of Dimes Foundation, the American Academy of Pediatrics, the Spina Bifida Association, the National Council of La Raza, and Gruma Corporation – created a petition that asked the FDA to review and approve folic acid as an additive to corn masa flour. That petition was granted, and now manufacturers voluntarily add as much as 0.7 mg of folic acid per pound of corn masa flour, which is about the same as the levels found in enriched cereal grains since 1998

Safety First

Before the FDA granted an approval, they first had to ascertain whether or not it was safe to add folic acid to corn masa flour. This was not just a safety measure for expectant Latina women, but for anyone, regardless of age, sex, or ethnicity, who would be consuming products made using corn masa flour. Once the research was complete, the FDA found that the addition of folic acid to the food supply was indeed safe for everyone.

Keefe explained the process the FDA went through to approve the addition of folic acid, which includes that it was safe to consume in masa corn flour and that it remained stable and did not break down during manufacturing.