FDA-Regulated Products Use Color Additives Approved by the FDA

The above statement covers color additives used in food (human and animal), cosmetics, drugs, dietary supplements, and some medical devices. All color additives, other than coal-tar hair dyes, must legally be approved by the FDA and must be used in compliance with its approved uses, specifications, and restrictions.

Before granting approval, the FDA examines all related safety data to ensure that the color additive is safe to use for its intended purpose.

Food Additives Used in Animal Products are Approved by the FDA

Drugs for animals – pets, livestock, poultry, etc. – require FDA approval. (Minor animal species include chickens, turkeys, cats, dogs, horses, swine, and cattle).

The FDA plays no role in approving foods for animals, including pet food, but they do have a say in the food additives used in such products. The FDA goes to great lengths to ensure that animal foods, including pet treats, are made in conditions that are both safe and sanitary. They also ensure that all foods are properly labeled.

FDA Food Safety Modernization Act (FSMA) came up with a new regulation called the Preventive Controls for Animal Food rule. This legislation was put in place to make sure that food manufacturers took the proper steps required to prevent potential food contamination and to also ensure that proper practices (sanitation, safety, equipment use, etc.) are employed when food is being made for animals.

Cosmetics are Not Approved by the FDA

Cosmetics include such items as shampoos, perfumes, makeup, hair dyes, shaving preparations, and face and body cleansers. The ingredients and labels used in cosmetics are not subject to FDA approval before they go to market. The exception to this rule is color additives, other than coal-tar hair dyes. All cosmetics must be properly labeled and safe to use.

Medical Foods Do Not Require FDA approval

Medial foods are those which are used for patients in need of dietary management for a specific health issue or nutrient needs. One example would be the medical food that is used on patients who suffer from phenylketonuria, a genetic disorder.

Someone suffering from this specific disorder would be required to eat foods that do not contain the amino acid phenylalanine. These types of food are intended for patients under the supervision of a medical professional. Meal replacements and diet shakes are not considered medical foods, as are foods used to manage ailments like diabetes. Making changes to a normal diet is generally what is required for those who have weight issues or who suffer from diabetes.

Premarket approval from the FDA is not required with medical foods, although there are other requirements that need to be met by the manufacturers of these products. These include things like the registration of food facilities and the following of good manufacturing processes. While nutrition information does not need to appear on the labels of medical foods, the information shown on the label cannot be misleading in any way.



Is a hacking cough making you feel lousy? Don’t grab a random box of cough medicine off the pharmacy shelf. The role of cough medicine is to ease symptoms while your body heals.

As a glance at the drugstore shelves will show you, there are many, many brands of OTC cough medicines. But there are only three basic types:

  • Expectorants help thin mucus, making it easier to cough up. The ingredient guaifenesin is the only expectorant in the U.S., so look for it on the label if you need an expectorant.
  • Suppressants help cut the number of times you cough. The active ingredient listed is usually dextromethorphan (DM). Other cough suppressants include camphor, eucalyptus oil, and menthol.
  • Combination cough products have more than one active ingredient. They have both guaifenesin and dextromethorphan. Cough medicines may also contain ingredients to help coat and soothe the throat. Combination products may have medicines to ease other symptoms, that may include decongestants for stuffy nose, antihistamines for allergies or a runny nose, or painkillers. Choose a medicine that matches your symptoms.
  • Cough drops can also help relieve a cough and may ease a sore throat.

Many OTC cough medicines have multiple ingredients — expectorants and suppressants along with decongestants, antihistamines, or painkillers. Select products with only the medicines that treat your symptoms. If your symptom is only a cough, for instance, you don’t need a decongestant or painkiller.

If you need to treat multiple symptoms, check other medicines you take to see if they contain the same ingredients. Don’t take two medicines that have the same ingredients. If you have any questions, ask your pharmacist or doctor.


Medical Devices are Regulated by the FDA Using a Risk-Based, Tiered Approach

Devices classified by the FDA are done so using risk measurement. Class III devices, such as implantable fusion pumps and mechanical heat valves, are considered to be the highest risk, and as such, require premarket approval from the FDA. Before gaining approval, manufacturers are required to deliver valid scientific evidence that clearly indicates their products to be safe, as well as an effective treatment method for the intended user.

In most cases, the FDA will “clearClass II devices – catheters, dialysis equipment, etc. – which are considered to be moderate risk. In order to be approved and take these devices to market, manufacturers need to be able to prove that their device is as safe as similar devices that have already received premarket approval.

Class I devices are considered to be the lowest risk of all, and they include items such as exam gloves, elastic bandages, tongue depressors, breast pumps, and more. General controls are in place for these items, which are exempt from premarket notification requirements.

Human Cells and Tissues are Approved by the FDA Using a Risk-Based Approach

Human cells, tissues, and cellular and tissue-based products that are to be used in humans can spread infectious disease, which is why the FDA regulates these products. If the product is deemed to pose any additional risk, it will require pre-marketing approval from the FDA. Products that fall under this category include corneas, bone, skin, tendons, dura matter, ligaments, reproductive tissue, and heart valves.

Tobacco Products are Not FDA Approved

Tobacco products are considered unsafe by nature, which is why there is no effective standard that the FDA can use to evaluate and approve them for human consumption. Instead of approving these products, the FDA regulates them based on a public health standard that takes into account the risks that users face.

Manufacturers looking to introduce new tobacco products in the U.S. are required to receive a written order from the FDA. Manufacturers have 3 different methods of getting a new tobacco product to market: premarket tobacco applications, substantial equivalence applications, or exemption from substantial equivalence.

It should be noted that tobacco products are neither approved nor considered safe once they receive a marketing order. All it means is that the manufacturer has legally followed the steps to bring their product to market.

Additives Used in Food for Humans Needs to be Approved by the FDA

While the FDA does not deliver premarket approval for food products, they do have control over certain ingredients that are used in said foods. At the top of this list are food additives, with substances like color additives among those that need approval.

Any company looking to include food additives in their products need to prove to the FDA that these additives are safe. Appropriate tests are performed by manufacturers, the results of which are then studied by the FDA to ensure that all additives are safe. After receiving approval, it is up to the manufacturer to ensure that the additives are used as they were initially intended.

Certain additives will contain food contact substances that can be transferred to food. These include things like antimicrobials, colorants, and antioxidants used in certain types of packaging. The review process used for these items is different, although the same standards are still applied. The manufacturer or supplier is considered in the notification process. Once the FDA is done with their review, they will allow that food contact substance to be marketed as long as no objections are found.

GRAS (generally recognized as safe) food ingredients are usually given that label by scientific experts and are not required to have premarket approval. The FDA allows manufacturers to submit conclusions that show their food additives to be considered GRAS.


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.


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.


The number of people suffering from diabetes is on the rise, and that has led to more and more illegally marketed cures and treatments flooding the market.

It probably comes as no surprise to learn that The U.S. Food and Drug Administration (FDA) advises consumers to steer clear of these treatments. Some of these supposed “wonder cures” are sold as over the counter treatments when they actually contain ingredients that should make them prescription drugs. One of the big issues here is that diabetes sufferers often go off effective legal drugs in favor of the illegal variety. Without the proper care and treatment, these people can end up becoming at risk for even more serious health issues.

According to the Centers for Disease Control and Prevention, in the US alone, more than 29 people deal with diabetes, with roughly 7 million going undiagnosed. There are millions more who are in the pre-diabetic stage, which means that they have high blood sugar levels that could effectively be brought back to normal with proper diet and exercise.

In discussing the rise of illegal diabetes treatments, Jason Humbert, a commander with the U.S. Public Health Service, of FDA’s Office of Regulatory Affairs, spoke about how people who suffer from chronic ailments will often become desperate and go with any type of treatment that promises to help, regardless of the risks. He also warned that failing to follow proven treatment plans can lead to further health issues, with the likes of kidney disease, blindness, amputations, and even death being near the top of the list.

Unapproved Diabetes Drugs

Several companies have received warning letters from the FDA in regards the marketing of diabetes products that are in violation of federal law. These products are usually marketed as the following: OTC drugs; ayurvedics, dietary supplements, alternative medical treatments, or homeopathic treatments. Diabetes is not the only disease targeted by these companies, with the likes of cancer, macular degeneration, STD’s, and more also on the list.

Upon inspection of supposed “all-natural” products, the FDA discovered that most contained undeclared active ingredients usually found in prescription diabetes medications. Serious health issues can arise from these undeclared active ingredients. Consumers and doctors unaware of these ingredients may end up in a situation where said ingredients interact in potentially harmful ways with legally prescribed treatments. One of the most common complications is that the recommended daily dosage of a diabetic drug may be exceeded. The end result in this circumstance would be a big drop in blood sugar levels that is referred to as hypoglycemia.

Online pharmacies who illegally market prescription drugs are also a target of the FDA. There are several ways to spot legitimate online pharmacies, and they include: requiring consumers to have a physical US address, requiring patients have a valid prescription, being licensed by a state pharmacy board, and having a pharmacist on hand to answer questions about medications.

Illegal online pharmacies often market and sell drugs that have not been approved in the US. They may also sell medications without the consumer being required to present a valid prescription. The FDA cannot guarantee that the drugs sold on these sites are safe or effective, or that they have not been contaminated or tampered with.



Carb Counting and Blocking

February 11, 2018

Low carb diets are popular. It is like everywhere you look you find a variation of these. The reason it is so popular is simple; it works. But what if you love your breads, pastas, and potatoes? Can you eat carbs and still lose fat? In this post we shall look at the benefits of natural carbs blockers and whether they can help you lose fat.

While cutting down on some carbohydrate foods such as white bread, white rice and other refined grains and sugars is recommended, cutting carbs drastically may not be a good idea. The reason is that you need carbohydrates for energy.

While the term “carb counting” appears to be more commonly used, we prefer the term “carb blocking”. This is not the same as carb cutting which, as mentioned, may not entirely be healthy. Carb blocking is about how your body manages (read utilizes) carbohydrates. You see, the digestive system breaks down carbohydrates into sugar, which enters your bloodstream. This causes the pancreas to produce the hormone insulin. This is the real enemy in your weight loss battles. Why?

Insulin prompts your body to absorb blood sugar for energy, or store it as glycogen in the liver and muscles, or as fat. However, due to poor dietary habits consisting of high levels of processed carbs, many of us have developed a certain level of what is known as insulin resistance. This means that body is not able to effectively use insulin.

Certain foods and compounds have been found to potentially influence the way the body manages carbs, which can influence body weight. These work in one of two ways:

  • Carbs blocking: Also known as starch blockers, carbohydrate blockers block amylase, a compound that helps digest carbs. This causes the carbs (and calories) to pass through the system undigested.
  • Improve insulin sensitivity: When your body is sensitive to insulin, only a small of the hormone amount needed to clear glucose from your system is released into your bloodstream. This is a good a thing as the presence of insulin can negatively affect fat burning.