Here are some 15 Products that have been ‘red-flagged’ by the FDA within 12 Months

Since its inception in 1992, the Food and Drugs Authority (FDA) has continued to deliver its mandate by inspecting, providing certificates, and ensuring proper distribution of foods and food products in Ghana.

The FDA has been at the forefront of consumer safety, protecting the public and, where necessary, banning or destroying unwholesome products.

Whether it concerns medicines, aphrodisiacs, orthodox medications, food sold to the public, or other products, the FDA has made strides to sanitise products that harm human health.

The public will remember the heavy blow to Elizabeth Torgbor, popularly known as Mama Gee, who was arrested over the sale of products said to be good for sexual enhancement without approval from the FDA.

The FDA also enforces laws on advertisements to the letter, ensuring that celebrities are whipped in line to protect the youth and young ones who are easily swayed by the activities of their favourite stars.

Guideline 3.2.10 of Guidelines for the Advertisement of Foods was published by the FDA on February 1, 2016.

It states that: ‘No well-known personality or professional shall be used in alcoholic beverage advertising’.

The FDA contended that the guideline was necessary to stop minors from being hooked to alcohol due to the influence of celebrities.

It has resulted in a huge battle between Ghanaian celebrities who want to cash in on their brands and the FDA, culminating in the recent Supreme Court case by famous musician Michael Owusu Addo, aka Sarkodie, to have the apex court quash the FDA’s regulations.

The FDA continues with its mandate unabated, with the latest notice cautioning against improper use of naphthalene, which could lead to poisoning and death, in a worse case, if ingested or mishandled.

While naphthalene works as an insecticide, some Ghanaians place it in potable water with the false idea of benefiting from its medicinal properties.

As the public becomes increasingly health-conscious about food and drugs, The Ghana Report examines products that have been in the FDA’s bad books in the past year.

•  Misuse Of Naphthalene Products

On June 4, 2024, the FDA cautioned the public against misusing naphthalene products, some of which are banned in many countries.

According to the FDA, naphthalene products are registered as insecticides in Ghana and should be used as such.

In a statement, the FDA emphasised that naphthalene products in Ghana have labels and warnings, including the need to keep them away from children, food, water, and fire, as they are flammable.

“Several countries have banned products containing Naphthalene due to incorrect labelling of naphthalene balls as ‘camphor’ and the associated toxicity risks from inhalation and ingestion, especially in children. However, these products remain in use in most countries, provided that the label instructions are followed.

“In Ghana, the FDA has registered naphthalene-containing products for use as insecticides. The FDA wishes to inform the public that labels on registered naphthalene products in Ghana contain sufficient information on their proper use, warnings, and cautions. These products should not come into contact with children or food, including water, and as a flammable material, should be kept away from fire”.

The FDA has prescribed specific labelling requirements for naphthalene-containing products, including directions for use and proper storage instructions.

It stressed that product misuse could result in adverse effects, but following the usage instructions will ensure safe use.

• Unhygienic Baby Diapers

The FDA has also banned various unbranded or unsafe diapers from being on the market.

In April 2024, the FDA issued a stern warning to manufacturers, importers, and distributors to desist from importing unregistered, poor-quality, and unhygienically packaged baby diapers into the country.

In a statement, the FDA emphasised that unregistered packed baby diapers, popularly known as bale diapers, were not permitted into the country.

Hence, the importation of such products will result in their seizure and safe disposal at a cost to the importer.

“The Authority has noted, with great concern, the continuing practice where disposable baby diapers are still imported into the country, either unhygienically packaged in bales or hidden in bales of used clothing. These baby diapers are subsequently repackaged and offered for sale without adequate label information or no labelling information at all.

“The public is to note that materials used for baby diapers are tested by the Authority during the product registration process. This ensures that any dyes, skin irritants, or toxins are absent so as not to cause harm to babies. In addition, handling of bale diapers, frequently re-packed and relabelled under insanitary conditions, can cause germs to enter the genital region of a child, especially a girl child, further posing great danger to their health and well-being,” excerpts of the statement read.

The FDA further urged the public to help ”protect babies from the risk of infections by buying only FDA-registered baby diapers”.

•   Non-Iodisation Salt

Salt is an essential cooking ingredient; however, the FDA has cautioned the public against the consumption of non-iodised salt.

Due to this, the Authority directed artisanal and large-scale salt producers, importers, transporters, storage facilities, and retailers of edible salt to regularise their operations with the Authority in January 2024.

The caution followed a market survey conducted by the Food and Drugs Authority (FDA) in which the artisanal salt industry was identified as a major non-compliant by stakeholders, particularly producers of non-prepackaged or unpackaged rock salt.

The survey, which was conducted in 2023, partly concludes that most of these salts are not iodised as required by law.

The survey also indicated that most artisanal producers are currently producing in facilities with structural and operational deficiencies, which can impact the quality and safety of salt produced.

It maintains that the call is to ensure that the public is protected from Iodine deficiency disorders in pursuance of the provisions of the Public Health Act, 2012 (Act 851). The Act stipulates that all salt-producing and manufacturing facilities shall be licensed by the FDA and that all packaged salts must be registered before being put on sale.

The Authority cautioned that those who violate the provisions of salt iodisation as stated by the law will be prosecuted.

• Unsafe/Unregistered Mineral Water

The sale of unregistered or unrecognised products like water on the market is punishable by law, per the FDA’s legal condition.

In January 2024, the Authority identified an unregistered water product called ‘SLIMFIT’ on the market and warned the public not to take it because it hasn’t been approved.

The FDA clarified that the original brand name registered with its outfit is SLEMFIT (mineral water and purified water), produced by the Twellium Industrial Company Limited.

Also, in July 2023, the FDA warned the public against consuming Perfect Ice Drinking Water, Aqua Link Drinking Water, and Leaders Drinking Water, manufactured by Samdoe Enterprise, located at Community 18, Spintex.

FDA, in a statement, said the inspection team uncovered major safety and quality issues, including operation in an unsuitable wooden structure, the presence of open drains with algae and fungi growth, dirty filters, and no pest control regime.

The statement also urged consumers not to patronise unregistered products as their safety and quality cannot be guaranteed.

• Expired Products

The FDA does not permit the sale of expired products on the market.

In December last year, the Authority urged the public to be wary of buying and consuming poisonous products during the Christmas festive season in the name of promotions and cheap prices.

It warned that many products nearing expiry were often dumped onto the market at incredibly low prices for the unsuspecting public during the season.

• Substandard Medicines – FDA

In September 2023, the Food and Drugs Authority (FDA) cautioned the public to be wary of fake and substandard medicines on the market to protect their health and well-being and prevent adverse reactions.

“We have realised as a regulatory body that there has been an influx of substandard and falsified medications on the market, so there is the need for the public to look out for certain things to make sure that whatever medication they go to buy is safe for use,” Mr Jude Okai, a Communication Officer at the FDA, warned in an interview on the sidelines of a sensitisation programme held at Bolgatanga in the Upper East Region.

It was part of the rollout of a project dubbed “promoting quality medicines plus” that was implemented by the FDA to raise awareness among the public about fake and substandard medicines on the market and the adverse effects of taking such medication.

The sensitisation was also to introduce the public to the “Med Safety App,” a new tool developed by the FDA to help the public report adverse reactions to medicines to the FDA or healthcare workers for prompt action.

• Dyes In Reusable Cloth Pads

The surge in the price of sanitary pads has left vulnerable young girls or female adults to fall for reusable pads that contain dyes.

Meanwhile, the FDA does not fully support the use of reusable pads soaked in dyes.

In June 2023, the Authority urged menstrual health and hygiene stakeholders to conduct further research before supporting reusable sanitary pads.

According to Rowland Sefakor, the Head of Medical Devices at the Food and Drugs Authority (FDA), some of the fabrics used to make these pads contain chemicals that threaten users.

He said this while speaking at the 2023 Period Summit, which was held in Accra as part of the 2023 World Menstrual Hygiene Day celebrations.

Mr Sefakor said it was important for all stakeholders to consider the quality of cloth used in production while advocating for reusable pads.

The reusable sanitary pads are made of materials that can absorb menstrual blood for four hours.

“In most cases, these cloths do not have the potency to absorb, and when you wash, it gives out colour, and these dyes are sometimes very harmful,” he said.

He also stated that, despite the advocacy for reusable sanitary pads, the FDA had not established standards for them.

As a result, he recommended that stakeholders reduce their use of reusable clothes and conduct additional research on the product’s quality.

•  Polyfort Syrup

The FDA cautioned the general public on May 9, 2023, about the recall of all batches of Polyfort Suspension in Nigeria.

According to the FDA, the recall was due to negative results from a series of ongoing stability tests.

The FDA said the drug is used for the treatment of heartburn, indigestion and hyperacidity and is manufactured in Nigeria by Swiss Pharma Limited.

The FDA issued a release stating, “The FDA’s surveillance team is actively monitoring the country’s ports of entry and markets to ensure that such unregistered products are not available in the country.”

• Unregistered Alkaline Water 

The Food and Drugs Authority(FDA) cautioned the public on May 5, 2023, against purchasing and using an unregistered water brand in the Ghanaian market.

A statement from the FDA said that the manufacturers of Kangen Water, which is 100% alkaline, only acquired registration for the production of drinking water.

However, they opted to misrepresent the FDA number by using it for its 100% alkaline water and then promoting it as bearing medical and healing capabilities.

“It is important to note that the medicinal and healing properties of the product as being advertised have not been subjected to any scientific analysis. Therefore, the Authority cannot guarantee its efficacy and safety for these claims,” the statement said.

It added that section 100 (1) of the Public Health Act 2012 (Act 851) makes it an offence to advertise food as a preventive or cure for a disease, disorder, or abnormal physical state.

Additionally, Act 851 prohibits advertisement for the treatment of diseases such as hypertension, cancer, and diabetes.

Therefore, the Authority has shut down the company’s operations and directed the manufacturers to recall the products.

• Oxytocin Injection 10iu/Ml 

The FDA has cautioned health facilities across the county against the use of unregistered Oxytocin Injections at 10iu/ml.

In April 2023, the FDA revealed that some health facilities across the country are administering unregistered Oxytocin Injections at 10iu/ml.

According to the FDA, these pharmaceutical products are not registered, so their quality, safety, and efficacy cannot be ascertained.

In a statement issued on Friday, April 21 2023, the FDA said the unregistered brands are Beltocin by Belco Pharma PVT Ltd, Oxytocin by Entrance Pharmaceuticals, Oxytocin by AMROS Pharma, Oxytocin Anhui Hongye Pharmaceutical Company Ltd and Oxytocin Jackson Laboratories PVT Ltd.

Others are Gold Vision by Anhui Hongye Pharmaceutical Company Ltd, Derm by Shandong Shenglu Pharmaceutical Company Ltd, A-tocin by Health Care Pharma, Extocin by Anhui Hongye Pharmaceutical Company Ltd and Pitons manufactured by Shanxi Shuguang Pharm. Company Ltd.

Oxytocin Injection is a medication administered to begin or improve labour and is also used to reduce bleeding after childbirth.

The FDA, therefore, informed all health facilities and medical stores in possession of these products to “stop using them immediately and return them to the nearest FDA offices throughout the country”.

• Ezricare Artificial Tears and Delsam Pharma’s Artificial Tears

In March 2023, the Authority warned the public against the use of Ezricare Artificial Tears and Delsam Pharma’s Artificial Tears by Global Pharma eyedrops suspected to have killed three people in the United States.

According to the FDA’s statement issued on Thursday, March 23, 2023, the US Centre for Disease Control and Prevention (CDC) found that the eyedrops contained the drug-resistant bacteria Pseudomonas aeruginosa.

They are also suspected of leading to three deaths and vision loss in eight patients.

This has led the manufacturers to recall the products.

FDA added that the products have not been registered with the authority, and “therefore, they should not be commercially available on the Ghanaian market.”

“However, the FDA advises the public who may be in possession of these drugs through other means to immediately stop using the recalled products, Ezricare Artificial Tears and Delsam Pharma’s Artificial Tears, and submit them to any of the FDA offices nationwide,” the alert stated.

• Misuse of Dry Ice

The Food and Drugs Authority (FDA) has cautioned bartenders and the public in March 2023 against the excessive use of dry ice in the preparation of cocktails, as it can be detrimental to their health if not handled carefully.

The use of dry ice in cocktails has become increasingly popular in recent years, as it adds a unique and impressive visual effect to many cocktails because of the dramatic “smoking” effect it creates.

In a health note, Mrs Delese Mimi Darko, the FDA’s Chief Executive Officer (CEO), explained that dry ice sublimates when added to drinks.

It is extremely cold, around -78.5°C, and colder than regular ice, making it a good option for chilling drinks quickly.

“Use only small amounts of dry ice in cocktails, as a little goes a long way when it comes to creating the smoking effect,” Mrs Darko said, adding that using too much dry ice could cause an excessive amount of carbon dioxide gas inhalation.

According to the FDA, dry ice, which is a solid form of carbon dioxide, is not toxic but could pose some respiratory challenges to consumers and cause burns when it comes into contact with the skin.

This makes it move directly from the solid state to the gaseous state, releasing carbon dioxide gas, which could displace oxygen in the air and create a hazardous environment, particularly in small or enclosed spaces.

The Authority, which is responsible for regulating food and medicine in Ghana, asked bartenders and the public to ensure that they always wear gloves and use tongs and other appropriate tools to handle the dry ice.

•  Fante Kenkey wrapped in Polyethylene

Traditionally, Ghanaians located in the south, where the delicious ‘Fante Kenkey’ is made, use plantain leaves to wrap the ‘kenkey’ before cooking.

Along the line, some of the indigenous people in the ‘kenkey’ business resorted to wrapping the food in plastic films (polyethene) before cooking.

This new development, according to the FDA, is very unhealthy and must be stopped.

The FDA justified that the temperature at which the kenkey is cooked with wrapped polyethylene (which contains bisphenol A, BPA) could release some harmful chemicals and toxins in the plastics into the food.

BPA, along with other chemicals, is used as a precursor material in the manufacturing of plastics. Health experts say its high level of exposure to humans could pose some health risks.

The Authority said the cooking process involving the use of wrapped polyethylene could contaminate the food and cause hormonal imbalances, reproductive issues, cancer, and immune system damage to consumers.

• Fake Anti-Malarial Drug 

In February 2023, the FDA cautioned the general public against patronising a counterfeit anti-malarial drug on the market.

Samples of the counterfeit drug taken from the Northern Region did not contain any of the two active pharmaceutical ingredients stated on the label; hence, they can be classified as falsified.

“The Food and Drugs Authority (FDA), as part of its market surveillance activities, wishes to bring to the attention of health workers and the public the presence of falsified (counterfeit) antimalarial drug- COMBIART Tablets (Artemether/Lumefantrine 20/120) on our market,” the FDA warned in a statement.

Therefore, it admonished the general public, particularly health workers, to be on the lookout for the drug and report to the appropriate Authority.

The FDA urged the public to look for details on the drugs, such as Batch number 7225119, Manufacturing date 03/2021, Expiry date 02/2024, Manufacturer Strides Arcolab Ltd, and NAFDAC Registration A4-6700.

•  Abuse Of ‘Laughing Gas’

Laughing gas, which healthcare providers use as a sedative to help relax patients during procedures, according to the FDA, is being abused by the public, especially at night clubs.

In a statement, the FDA indicated that the abuse of Nitrous Oxide gas was extremely hazardous and included risks of low blood pressure, heart attack and anaemia.

The notice added that abusers of Nitrous Oxide gas are also prone to the risk of suffocating and loss of consciousness.

The FDA said its attention had been drawn to the abuse/misuse of Nitrous Oxide gas at nightclubs and parties in the forms of balloons and canisters to induce euphoria and laughter.

It also admonished nightclubs, pubs, and party organisers to refrain from the inappropriate use of laughing gas in their facilities.

“Long-term recreational use(abuse) of Nitrous Oxide gas could also compromise the immune system, mental and neurological disorders (hand and foot numbness and limb spasms), depression and incontinence,” the notice said.

By Grace Tsotsoo Quaye || The Ghana Report