Glutathione Harmful to Pregnant Women -FDA WARNS

By Anna Claudia Duker

The Food and Drugs Authourity (FDA) has cautioned the public especially pregnant women and lactating mothers to desist from the use of glutathione to lighten the skin of their unborn babies, due to  the serious health problems it poses.

The Chief Executive Officer (CEO) of  FDA, Mrs. Delese Darko stated the Authority’s intelligence and market surveillance has revealed that glutathione contain dosages ranging between 1,500,000mcg-and 2,000,000mcg (1500-2000mg) per tablet.

Addressing the media in Accra yesterday, she stated that the doses far exceed the recommended registered dosage of glutathione preparations approved by the FDA. She said  element  have been shown by medical science to cause side effects like nausea, vomiting, hair loss, allergic reactions and serious toxic side effects including exacerbated asthma, toxic epidermal necrosis renal failure, chest pain/breathing problems and damage to the lungs.

According to her, glutathione come in the form of creams, tablets, capsules, pills and injectables.

Glutathione is made up of three amino acids; cysteine, glutamic acid and glycine which are naturally produced by the bodies and found in almost every cell in the body.

Glutathione when used as a dietary supplement at doses of 250-500 mg daily raises energy levels, strengthening the immune system, fighting inflammation and aiding in cellular repair.

Currently she said, the FDA has registered some brands of glutathione in accordance with section 118 of the public health Act 2012, Act 851 as dietary supplements in minimal doses of 100-500mg per day for an adult.

The CEO stated as a food supplement, glutathione capsules should not be marketed as drugs or cosmetics and doing so is clearly a contravention of section 113B of the public health Act and criminal in intent.

She said, these high strength glutathione containing products are brought into the country illegally and are being sold on the open market.

According to her, some of the brands found on the market include GLUTA PRIME, PHYTO COLLAGEN, KING OF WHITENING, GLUTA WHITE AND IVORY CAPSULES skin enhancement formula have not been registered by the FDA.

She indicated the FDA has intensified monitoring of border posts and market surveillance across the country and also cautioned persons found offering them for sale or distribution will face the necessary regulatory sanctions and the full rigors of the law.

The CEO mentioned the Authority has embarked on a number of swoops nationwide and seized some products and also arrested some number of sellers who are assisting in investigation to establish how the products enter the country and the distributors.

She noted that the side effects of the product is the slowing down of the production of melanin resulting in less melanin pigment giving the skin a lighter colour adding that scientific information is not available on the safety of the chronic and long term use and side effects of Glutathione as a skin bleaching agent.

Updating the media on issues pertaining to high strengths of tramadol and codeine containing cough syrups Mrs. Darko said the Minister of health has in the interest of public health and safety and pursuant to section 116 of Act 851 proceeded to ban the importation and manufacture of codine-based cough syrups by an Executive Instrument presently under consideration due to FDA’s Technical Advisory Committee (TAC) recommendations.

She added that the Authourity is working together with Pharmacy Council, the Police and other collaborating institutions like NACOB to ensure that tramadol and codeine containing cough mixture abuse is dealt with.

On his part, The President of Consumer Protection Agency Kofi Capito urged the media to desist from using comic statements in their reportage of the dangers of substances abuse especially the local stations.

He further cautioned women to refrain from using bleaching products as it has severe medical conditions on their health.