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Approved by the FDA or Not? Part 3

April 19, 2018

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.


 

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