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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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Drugs or Cosmetics?

August 28, 2016

Americans spend quite a bit of money on lotions, creams and cosmetic products that offer a promise of improved eyelashes, hair and skin. In many cases, these promises go too far in what they have to offer the consumer.

The FDA or Food and Drug Administration warns those that make cosmetics to be careful when they make claims about product and to classify them as drugs and not cosmetics. The FDA has sent warning letters citing drug claims associated with hair care, topical skin care, eyebrows, and eyelashes. These claims were found on websites as well as product labels. Some examples of drug claims are for dandruff treatments, acne treatments, as well as restoration of hair.

The letters say that the products on the market have drug claims. Meaning that the product is intended to prevent or treat a disease or change body functions or structure. The FDA wants companies to remove drug claims from products or seek the FDA approval to market cosmetic products as drugs.

Consumers need to know that drug claims on these products are not approved by the FDA when they decide to buy one of the products says MPH, director of FDA’s Office of Cosmetics and Colors, Linda M. Katz, M.D. The FDA must evaluate the products as drugs before the company can claim that the product treats skin problems or changes the skin.

Drug claims have gone as far as to say the product changes elastin or college of the skin. Other claims include that the product prevents wrinkles or allows for firmer and more elastic skin.

Some products say that there’s regeneration of cells, reduce inflammation, less facial muscle contractions or give you the same results as surgery or injections. Conditions like psoriasis, eczema, rosacea, and acne are promise dot be treated.

Drugs or Cosmetics?

The federal law sates that a cosmetic is designed for beautifying, cleansing, altering appearance or promoting attractiveness. The FDA is not required for approval before these products go to the market.

Drugs are defines as products intended to cure, diagnose, mitigate, prevent, or treat a disease or condition. A drug is also said to affect the structure or function of the body. Drugs need FDA approval in most cases before they can be marketed to consumers.

Many companies have crossed the line and stated that their products will enhance a person’s appearance or that the structural appearance of the skin and will prevent or treat certain medical conditions.

For several years the FDA has been tracking claims that have been made about cosmetic products and there are many claims on the Internet or on product packages that simple aren’t true. If a product is making a drug claim then they have to be evaluated as a drug and not a cosmetic product.

If a company can’t comply then more action besides a warning letter is taken and the product may be removed from the marketplace altogether.

Skin Care Herbs

August 14, 2012

We would like to attract your attention to the skin care herbs that are useful for everyone:

  • Dandelion root belongs to the family of Asteraceae or sunflower, and it is very useful thanks to its detoxifying properties in case you have blemishes.
    This herb, commonly growing also in the yards, contains a lot of other elements that are useful to health in genera such as choline, bitter compounds, inulin: such minerals as sodium, calcium, sulfur, silicic acid, as well as potassium in high concentrations found in its fresh leaves. In cosmetics it is used to treat and clear up a range of skin eruptions including eczema and acne.
  • Burdock is a plant, which can be met in different places of the world. From the earliest times experts used to cure eczema, acne, skin cancer and other skin diseases with the help of its root and leaves. It acts as a natural mild antibiotic and can help in obtaining skin smoothness.
  • If you have a chronic skin disease, try yellow dock, a weed with general tonic effects, which has been effectively used for skin conditions since the ancient times.Yellow dock decoctions are useful for such skin problems as contact dermatitis, atopic eczema, skin rashes, acne rosacea and herpes outbreaks.
  • Echinacea strengthens the immune system, increases the production of white blood cells and improves the cell walls so that viruses and bacteria have little chance to penetrate the cells. By using this plant one can safeguard himself from inflammation-related skin problems. These kinds of plants formerly were found wild on the flatlands of America and Canada; however they’re currently being farmed in European countries and most of Asia, plus North America.
    It is meant for boosting immune system and helping to overcome flue and colds. It should be taken orally. As to the skin disorders, it is useful in the treatment of eczema, psoriasis and bites of some insects. Purple Coneflower has inhibition properties and it inhibits bacteria and pus.
  • Red clover is applied to purify the blood as it removes toxins from it. It is highly effective thanks to big concentration of vitamins of B-complex group. Since ancient times in ethnomedicine fresh chopped or mashed red clover flowers have been applied just to skin as a remedy against inflammations, insect bites, for example. Lotions, creams, and ointments with the extract of red clover have been used in treating different skin conditions such as psoriasis, eczema and others.
  • If digested in moderate quantities, licorice can help you to treat skin inflammation and redness. There are poultices with licorice used to treat infectious diseases of the skin and dermatitis. Together with other herbal cleansers and cosmetic products it is used to lighten the skin.
  • Why do you think cayenne pepper is so hot? It is spicy feature is revealed thanks to capsaicin. This component can be applied directly to the skin in order to reduce pain and inflammation as it works on sensory nerves. This similar soothing feature can help to eliminate itchiness and irritation caused by skin psoriasis. Cayenne pepper works as a carrier agent that may activate and aid the activity of the some other elements to the skin oil glands and skin pores.

Of course you needn’t take all these herbs and mix them together at home to make your own skin care products and treat your acne at home. But study attentively the composition of those the skin care products, which you want to try. You can find these herbs in some skin treatment aids and they can help you.

You break out in a head-to-toe rash after applying a sunless tanning lotion. Your son’s skin is red and blotchy after he gets his face painted at the school carnival. Your daughter’s scalp is burned after using a hair relaxer.

If you’ve had a negative reaction to a beauty, personal hygiene, or makeup product, the Food and Drug Administration (FDA) wants to hear from you.

From morning until night—styling our hair for work to showering before bed—Americans depend upon personal care products. Most are safe, but some cause problems, and that’s when FDA gets involved.

“Even though these products are widely used, most don’t require FDA approval before they’re sold in stores, salons, and at makeup counters,” says Linda Katz, M.D., director of the agency’s Office of Cosmetics and Colors. “So, consumers are one of FDA’s most important resources when it comes to identifying problems.”

When you contact FDA, include the following information in your report:

  • the name and contact information for the person who had the reaction;
  • the age, gender, and ethnicity of the product’s user;
  • the name of the product and manufacturer;
  • a description of the reaction—and treatment, if any;
  • the healthcare provider’s name and contact information, if medical attention was provided; and
  • when and where the product was purchased.

And be sure to give the age, gender, and ethnicity of the person who had the reaction, says FDA scientist Wendy Good, Ph.D. Good, who analyzes reports about problems with cosmetics, says that information is important because it can help scientists spot trends.

When a consumer report is received, FDA enters the information into a database of negative reactions. Experts then look for reports related to the same product or similar ones. FDA scientists will use the information to determine if the product has a history of problems and represents a public health concern that needs to be addressed.