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.


 

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Age-related Macular Degeneration

Age-related macular degeneration — also called macular degeneration, AMD or ARMD — is deterioration of the macula, which is the small central area of the retina of the eye that controls visual acuity.

The health of the macula determines our ability to read, recognize faces, drive, watch television, use a computer, and perform any other visual task that requires us to see fine detail.

Macular degeneration is the leading cause of vision loss among older Americans, and due to the aging of the U.S. population, the number of people affected by AMD is expected to increase significantly in the years ahead.

According to a recent study by researchers at the University of Wisconsin School of Medicine and Public Health and the U.S. Centers for Disease Control and Prevention (CDC), approximately 6.5 percent of Americans age 40 and older have some degree of macular degeneration. Other research suggests there were 9.1 million cases of early AMD in the U.S. in 2010 and this number is expected to increase to 17.8 million by the year 2050.

AMD is most common among the older white population, affecting more than 14 percent of white Americans age 80 and older. Among Americans age 50 and older, advanced macular degeneration affects 2.1 percent of this group overall, with whites being affected more frequently than blacks, non-white Hispanics and other ethnic groups (2.5 percent vs. 0.9 percent).

Progression to wet macular degeneration is the main complication of dry age-related macular degeneration. At any time, dry macular degeneration can progress to the more severe form of the disease called wet macular degeneration, which may cause rapid vision loss. There is no accurate way to predict who will eventually develop wet macular degeneration.

Other eye diseases such as cataracts, glaucoma, retinal detachment, or dry eyes are not complications of macular degeneration. Patients with macular degeneration can, however, develop these or other eye diseases and people with these conditions can also develop AMD concurrently.

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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.


 

A Quick Review of OTC Cough Medicine

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.

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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.