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Monday, April 25, 2011


Cosmetic products have become an unavoidable part of human beings. Food, Drug, and Cosmetic Act defines “cosmetics” as products that are intended to be applied to the body “for cleansing, beautifying, promoting attractiveness, or altering the appearance.” But the legal definition includes items such as face and body cleansers, deodorants, moisturizers and other skin lotions and creams, baby lotions and oils, hair care products, dyes, conditioners, straighteners, perms, makeup, hair removal creams, nail polishes, shaving products, perfumes and colognes, face paints and temporary tattoos and permanent tattoos and permanent makeup. Countries have different list of such products. So, you must contact the Food, Drug and Cosmetics regulatory authority before identifying a marketed product as “Cosmetic”.


  Regarding FDA, most of these products don’t require FDA approval before they’re sold in stores, salons, and at makeup counters. So consumer feedback is one of FDA’s most important resources when it comes to identifying problems of such products. If you’ve had a negative reaction to a cosmetic product as listed above,then you must report it to the Food and Drug Administration (FDA), if you resides under the jurisdiction of FDA. Most of the countries maintain their own reporting system, which you can get information from health authorities in your country.


How and what to report

Consumers should contact FDA if they experience any sort of undesired effect while using a cosmetic even if they fail to follow specific instructions by the company on using the product.

When you contact FDA for reporting an undesired effect, then you must include the following information such as

  • 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

 MedWatch, FDA’s problem-reporting program, on the Web  is the easy and quick method to report by consumers. Alternatively you can contact over telephone at 1-800-332-1088; or contact the consumer complaint coordinator in your area.

What FDA do on such a report from consumer

FDA enters the information into a database of negative reactions based on the feedback provided by the consumer. There is nothing to worry about this as the identity of consumer who reported the problem will remain confidential. FDA scientists and experts review the issue and try to find similar issues being reported from other consumers. If they identify this as a serious issue, then actions could be depending upon the product and the problem that may range from issuing a consumer safety advisory to taking legal action.

Source: FDA's Consumer Updates page

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After the recent tsunami, Japan is suffering from nuclear leak from many of its nuclear reactors. Steam with radionuclide contamination disperses in the air and deposits on water/ground surface. The contamination, however depends on how wide an area depends, how high the steam is propelled and on wind speeds at that altitude range. If the radionuclide deposits on water, it is further dispersed but If the amount of water available is large, the concentration becomes very low.  Scientists and experts say that due to the great quantity of water in the Pacific Ocean, radioactive material that may dispersed in water will get diluted quickly and seafood are likely to be unaffected.

NUCLEAR CONTAMINATION Japan is a big exporter of human and animal foods, medical devices and radiation emitting products, cosmetics, animal and human drugs and biologics, dietary supplements, and animal feeds. The most common food products exported include seafood, snack foods and processed fruits and vegetables. The earthquake and  tsunami caused extreme damage to the area due to which almost 95% of the production, processing and exporting got interrupted prior to the explosion at the reactor. So it is believed that most of the Japanese products now available in the markets are possibly free of contamination.

Most countries have already initiated testing and analysis of food products imported from Japan. Until now no country reported any sort of  contamination in their imported products from Japan. In US, FDA is on high alert in monitoring and testing food products, including seafood, from all areas of Japan. United States Customs and Border Patrol (CBP) agents routinely use radiation detection equipment to screen food imports, cargo, and travelers. This screening helps identify and resolve potential safety or security risks.

Usually FDA will conduct a field examination, including time/temperature changes, water damage and collect a sample for radionuclide analysis at FDA laboratories. Regarding food and feed imports from Japan that originate outside the area of concern, FDA will collect a sample for any radiation pager for radionuclide analysis reading of 1-8, and as additional surveillance and as resources allow, collect other samples for radionuclide analysis as resources permit, for readings of 0 on the radionuclide pager.

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The earthquake, Tsunami and the nuclear reactor explosion raised many questions in the mind of common people. The news about nuclear contamination to sea water and the surroundings in certain areas of Japan triggered panic among regular customers of imported Japanese food especially seafood. Scientists and experts say that due to the great quantity of water in the Pacific Ocean, radioactive material that may dispersed in water will get diluted quickly and seafood are likely to be unaffected.

MEDICINE NUCLEAR CONTAMINATION I recently got an email asking about the products that are available in the market that can treat a possible internal contamination of radionuclide material. I believe to depend of FDA approved stuff, so stating details about such drugs and products. After the nuclear incident in Japan, the demand for drugs used to prevent and treat harmful effects caused by radiation exposure or contamination with radioactive materials have increased. But after referring many websites, I suggest that there is no need to panic in countries other than Japan.

As they say in the FDA website, there are three FDA-approved potassium iodide (KI) products for use as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment. The three over-the-counter products are:

  • Iosat Tablets (130 mg), Anbex, Inc., Williamsburg, Va.,
  • ThyroSafe Tablets (65 mg), Recipharm AB, Jordbro, Sweden,
  • ThyroShield Solution (65 mg/mL), Fleming & Company Pharmaceuticals, Fenton, Mo.

When administered at the recommended dose, KI is effective in reducing the risk of thyroid cancer in people at risk for inhalation or ingestion of radioactive iodine. KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules. Potassium iodide works only to prevent the thyroid from uptaking radioactive iodine. It is not a general radioprotective agent.

Potassium iodide is the only FDA-approved medication available to treat contamination with radioactive iodine. There are FDA-approved products available that increase the rate of elimination of other radioactive elements. They include:

  • Calcium-DTPA and Zinc DTPA, Hameln Pharmaceuticals. Approved to treat known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.
  • Radiogardase (Prussian blue insoluble capsules), HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG. Approved to treat known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium to increase their rates of elimination.

The FDA is alerting consumers to be wary of internet sites and other retail outlets promoting products making false claims to prevent or treat effects of radiation or products that are not FDA-approved. These fraudulent products come in all varieties and could include dietary supplements, food items, or products purporting to be drugs, devices or vaccines.

Consumers should be wary of the following:

  • claims that a product not approved by FDA can prevent or treat the harmful effects of radiation exposure;
  • suggestions that a potassium iodide product will treat conditions other than those for which it is approved, i.e., KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules, which are subsequently excreted in the urine;
  • promotions using words such as “scientific breakthrough,” “new products,” “miraculous cure,” ”secret ingredient,” and ”ancient remedy”;
  • testimonials by consumers or doctors claiming amazing results;
  • limited availability and advance payment requirements;
  • promises of no-risk, money-back guarantees;
  • promises of an “easy” fix; and,
  • claims that the product is “natural” or has fewer side effects than approved drugs.
  • claims that kelp, seaweed, and other food products contain enough iodine to protect against radioactive iodine. These products contain very little iodine when compared to the approved drug products. There are no foods or dietary supplements approved by FDA for protection against radioactive iodine

Don't be fooled by professional-looking Web sites. Avoid Web sites that fail to list the company's name, physical address, phone number, or other contact information. For more tips for online buying, visit Buying Medicines and Medical Products Online. To determine if a particular drug is FDA approved, check The Orange Book or Drugs@FDA.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of both approved and unapproved radiation exposure products to the FDA's MedWatch Adverse Event Reporting program at or by calling 800-332-1088.

Source: FDA

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