Approved by the FDA or Not? Part 4

Infant Formula is not Approved by the FDA

Infant formulas do not require FDA approval before going to market. That said, formula manufacturers are subject to regulatory oversight from the agency.

Federal nutrient requirements need to be adhered to when the formula is being made. Manufacturers looking to bring a new product to market must first register with the FDA and provide notification of intent.

Manufacturers facilities are inspected by the FDA on a yearly basis, during which time samples of the infant formula are collected for testing. If these tests show that the formula presents any type of health risk, the manufacturer will be asked to conduct a recall.

Dietary Supplements are Not Approved by the FDA

While new drugs need to be approved by the FDA before going to market, the same is not the case with dietary supplements. The exception here is if the product includes a new dietary ingredient, which would be one that has not been marketed in the U.S. prior to October 15, 1994. Manufacturers using such an ingredient must notify the FDA 75 days prior to marketing.

When the manufacturer submits the notification information to the FDA, they must deliver a conclusion that shows that their dietary supplement is safe. If a health concern arises after a new product hits the market, the FDA will use research and event monitoring to better evaluate the safety of the dietary supplement.

Food Labels, Which Include the Nutrition Facts Panel, are Not Approved by the FDA

Individual food labels are not approved by the FDA before food products hit the market. That said, food manufacturers are required to show nutrition information on foods, as well as dietary supplements. When manufacturers make claims about their products, they cannot include false or misleading information.

The Nutrition Facts panel on a food label must show the serving size of the food, as well as the nutrient content. With dietary supplements, that information is usually shown on the Supplement Facts panel.

The FDA Does Not Approve Structure-Function Claims Found with Foods and Dietary Supplements

Foods or food components that are made to affect the structure or function of the human body will have structure-function claims that describe their role. “Calcium building stronger bones” is an example of such a claim.

Manufacturers of dietary supplements who create products with structure-function claims on their labels are required to submit a notification to the FDA. This notification needs to be submitted to the agency no later than 30 days after the product has gone to market. Items that need to be included in the notification are things such as the text of the claim, the notifier’s name and address, and other relevant information. The structure-function claims made on dietary supplement come with a disclaimer which makes it clear that the product has not been granted approval by the FDA, and that it is not intended as a treatment, cure, or diagnosis of any disease.

Conventional food manufacturers do not need to notify the FDA, nor do they need to carry a disclaimer, about structure-function claims.


Approved by the FDA or Not? Part 3

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.


Approved by the FDA or Not? Part 2

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.


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.


Staying Informed to Stay Healthy

Doctors routinely prescribe the medications required to get you back to a healthy state, but are you aware of the proper dosage for those meds?

When you get a report back from the lab that is confusing, are you comfortable with asking your doctor about the results?

When you read the Nutrition Facts Label when grocery shopping, do you really know what all the information means?

Being able to answer “YES” to those questions means that you have a high health literacy, according to the good folks at the Food and Drug Administration (FDA). Jodi Duckhorn serves as the Director of Risk Communications for the FDA, and it is her job to ensure that the average person is able to understand all the messages sent out by the FDA. This ensures that more people will be health literate, and therefore able to make better health decisions.

Health Literacy Explained

When asked to explain what health literacy is, Duckhorn responded that it is the ability to understand the basics of health issues and medical services so that making an informed health decision is that much easier.

Unfortunately, it is estimate that only about 12% of the adult population in the U.S. an be described as having high health literacy, as per the National Assessment of Adult Literacy. The remaining 88% of the population may not have the essential knowledge required to make informed decisions about their health.

The federal Office of Disease Prevention and Health Promotion, believes that health literacy begins with a basic knowledge of subjects such as heart health and nutrition. Your doctor will pass on all the information you need to make good health decisions, but too many people fail to ask questions when they do not fully understand what they are being told.

Duckworth is of the belief that it is those lack of questions that can lead to confusion and poor health choices. For example, a patient being told that their test results are “negative” may think that negative means a bad result as opposed to a good one. If they fail to seek further information, they may leave the doctor’s office believing that they are in poor health when they are actually fine.

The Negative Consequences of Low Health Literacy

The most obvious negative consequence of having reduced health literacy means that you feel ill-equipped to ask pertinent questions and make important healthcare decisions. It also makes it close to impossible to interpret even the most basic lab results, or to understand things such as dosages and information on nutrition labels.

Being unaware of the healthcare options available to you also means an increased risk of hospitalization. Prevention is one of the best ways to stay healthy, but if you are unaware of the services that are out there, prevention often goes out the window, leading to higher health costs.

The FDA and the Promotion of Health Literacy

The FDA takes health literacy extremely seriously, which is why they go out of their way to communicate complex health topics in a manner that the layman can understand. They use a variety of different techniques to get accurate information out to the patient, as well as to the healthcare providers who look after them.


Indoor Tanning Products

Several risks are involved with using indoor tanning products. For instance, if you use an indoor tanning booth or bed, you are exposing your body to UV (ultraviolet) radiation, which promotes skin damage, eye injuries, melanoma and other skin cancers.

Because of the gradual impact of UV radiation, it places children, adolescents and young adults at a higher risk for eye and skin conditions in their later years. The FDA is determined to minimize the damage of UV radiation caused by indoor tanning products by prohibiting the use of these products by people under the age of 18. Also, indoor tanning sites are required to provide literature about the possible risks associated with using an indoor tanning product and have the consumer acknowledge the awareness of such risks by signing an acknowledgment form.

The FDA is also considering another rule that will require makers of indoor tanning products and tanning sites to create more proactive strategies to prevent injuries from using these products.

Dr. Markham Luke, dermatologist and deputy office director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health tells us that using indoor tanning products at a young age (childhood and young adulthood) increases the potential to develop melanoma and other forms of skin cancer. Markham also states that several hundred youth each year in the US get injured from using an indoor tanning product.

The American Academy of Dermatology states that exposure to indoor tanning products make people 59% more likely to have melanoma than people who have never used an indoor tanning product.

Studies conducted by the Centers for Disease Control and Prevention (CDC) between 2003 to 2012 conclude that there are over 3,000 emergency room visits in the US alone due to indoor tanning product-related injuries. Interesting enough, over 400 of the patients were adolescents under the age of 18.

Things to Keep in Mind for those Still Planning on Using an Indoor Tanning Product

Now the FDA has taken steps to prevent injuries to minors who use tanning products. FDA-approved products will carry a disclaimer that prohibits the use of the tanning product by people under the age of 18. Indoor tanning products are required to have a visible, black-box disclaimer that people under age 18 should not use the product. Also keep these points in mind:

  • Being exposed too long (like near the maximum time for the tanning device) can cause sunburn. Since it takes from 6 to 48 hours to realize your skin is sunburned, it’s going to be hard to tell if you’ve stayed exposed for too long.
  • If you take medications or use certain cosmetics, it may make you sensitive to the sun (UV radiation actually), so consult your physician or pharmacist prior to using a tanning product.
  • Neglecting to wear protective goggles while doing indoor tanning can cause temporary or long-term eye problems.
  • Always follow the directions for the tanning product. If you have skin that easily burns or is hard to tan (or does not tan at all), then it is highly recommended you do not use an indoor tanning product.

Get only FDA Approved Prescription Ear Drops

When your child next has ear pain the FDA wants to ensure they get only FDA approved prescription drugs that are effective and safe for your child.

The FDA is telling companies to cease marketing sixteen unapproved prescription drugs which have labels indicating they relieve swelling and ear pain. These drops contain active ingredients like hydrocortisone and benzocaine, but the FDA has not evaluated them for safety, quality, and effectiveness.

Pharmacies as well as health care providers have sold drugs that had labels which didn’t disclose that the product wasn’t approved by the FDA. Charles E. Lee, M.D of the FDA says that we don’t know if the drugs have any benefits and we can’t accept the chances that they may have risks.

Why FDA Is Taking Action at this Time

The FDA has its Unapproved Drugs Initiative, so it’s taking action. The FDA seeks to protect consumers from drugs that aren’t proven to be safe, of high quality, or effective.

It’s a risk to public health when a drug isn’t shown to be effective, especially if it has some safety concerns. The FDA has received reports that state the products can cause mouth, face, neck, eye, and ear local allergic reactions. Other symptoms can include burning, stinging, itching and irritation of the ear.

Unapproved ear drug products which require a prescription containing these ingredients are covered by the action of the FDA:

  • benzocaine and antipyrine
  • benzocaine, antipyrine and zinc acetate
  • benzocaine, chloroxylenol and hydrocortisone
  • chloroxylenol, pramoxine and hydrocortisone
  • benzocaine
  • chloroxylenol and pramoxine

The quality of the drugs isn’t known for certain. When a drug is approved by the FDA, the drug manufacturing process is reviewed which ensure that the drug is of purity ad well as consistent quality. These unapproved ear drops have not been examines in this way. The products are prescribed for infants and small children so this is troubling. Drugs that are intended to be used on children should be tested in children. The drugs mentioned haven’t bene shown to be effective in anyone so there’s no proof that the products actually work.

Alternatives Approved by the FDA Available

There are other treatment options available for children with ear problems. The FDAs action only impacts a small percentage of drugs prescribed to treat otitis externa (outer ear infections), excess buildup of earwax, and otitis media (middle ear infections). There’s also F many OTC products available that can be used for earwax buildup or swimmers ear.

There are other solutions for ear problems and choices for consumer sot make. You need to use the products that are known to be safe and avoid the ones that haven’t been test fully for safety and effectiveness.