FDA cracks down on Arcan Bitters, orders product recall within 14 days

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Arcan Bitters

The Food and Drugs Authority (FDA) has cracked down on Arcan Bitters, ordering Unni Associates Company Limited to recall the product from the market within 14 days.

According to the FDA, the manufacturing facility located at Parkoso in the Asokore Mampong Municipality of the Ashanti Region has also been shut down.

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The FDA disclosed that laboratory tests conducted on the 35% Alc/Vol drink revealed that it had been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor commonly used to treat erectile dysfunction and pulmonary arterial hypertension.

The FDA highlighted that the inclusion of an undeclared pharmaceutical ingredient in a registered food product poses severe health risks to consumers.

The FDA further emphasised that the adulteration breaches Section 100(3) of the Public Health Act, 2012 (Act 851), which prohibits the production, sale, or advertisement of adulterated products or goods that deviate from prescribed safety standards.

The Authority also noted that labelling and packaging a food item misleadingly or deceptively constitutes a regulatory offence.

“The presence of Sildenafil Citrate in a food product poses serious health and safety risks to the public. Sildenafil Citrate can interact with other medicines to cause a sudden drop in blood pressure, which may lead to stroke and heart attack,” the FDA stated in an official public notice. The regulator added that exposure to the substance “may cause long-term health problems, including loss of vision and hearing”.

“Arcan Bitters appears to have flouted all these requirements and more. Arcan Bitters is registered with the Authority as a Food Product (an alcoholic drink) and must not contain any drug substance,” the statement noted.

In other news, the Food and Drugs Authority (FDA), with the support of the Ghana Police Service and National Security, has stormed Makola Market in Accra to seize cigarette-shaped candy being sold at the Makola Market in Accra.

Reports suggest traders involved in the sale of cigarette-shaped toffees were also picked up.

The development follows complaints and social media posts raising concerns about the sale of the products on the Ghanaian market.

The FDA, in a Facebook post on Saturday, August 29, revealed that the products were seized during the operation.

They further disclosed that one suspect was arrested in connection with their sale.

According to the FDA, the depiction and advertising of tobacco and tobacco-related products are prohibited under the Public Health Act, 2012 (Act 851), and the Tobacco Control Regulations, 2016 (L.I. 2247).

They further disclosed that regulations prohibit the advertisement and depiction of tobacco and related products in the media and at points of sale.

The FDA highlighted that the enforcement action forms part of its efforts to ensure that regulated products available on the Ghanaian market are safe for the general public.

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