Swedish authority lifts ban on condom brand

Swedish authority lifts ban on condom brand
The Medical Products Agency (Läkemedelsverket) has rescinded its sales ban on the PutOn condoms brand after originally ruling that it failed to meet Swedish safety requirements.

An inspection showed the brand falls short of demands for the CE marking certifying that a product has met EU consumer safety, health or environmental requirements.

Swedish company Sibbarps International was first notified about the problem on October 5th and told it had three weeks to resolve it before a sales suspension was announced a week later.

“Even if this is bad publicity, it’s become good publicity for us. There has been a lot of activity on Google for our brand,” Sibbarps spokesman Ted Wendt told The Local.

Wendt added that it wants to make a product that consumers will want to use, pointing out it is targeting teenagers, who use condoms the least, since condom use is low in Sweden compared with other countries in northern Europe.

Given that Sibbarps did not receive an opportunity to comment on the information presented in the case, the authority has suspended its decision and will give the company opportunity to express its opinion before it continues its investigation.

“The manufacturer according to the label has received a letter and we are giving it the opportunity to comment. That is why we rescinded the decision. It did not have time to reflect on the decision before, but it was not a bad decision on our part,” agency section leader Helena Dzojic told The Local.

The agency had based its decision on information given by authorised representative Shanghai International Holding in Hamburg and the notified certification organ TÜV SÜD.

The company complained about the decision on Tuesday. It now has 10 days to respond to the agency’s findings. Wendt said the company will respond this afternoon.

“I think the main focus in this issue is that the agency broke the law. It is not allowed to make a decision before the company involved makes a statement to explain everything,” he said.

The agency examined the contents of a certificate from a certification body named TÜV SÜD. According to the certificate, the manufacturer of the product is a Chinese company called Yun Hai and a German company is its authorised representative in Europe.

In a written declaration, TÜV SÜD testified that it does not recognise the Chinese company and that the presented certificate is a forgery.

In a statement, Wendt explained that the CE mark had been mistakenly produced for Yun Hai, a subsidiary of PutOn manufacturer Dong Yang Songpu Latex (Jinzhou), which holds European certification.

Wendt added that the company has already corrected the font on the CE mark and will change the name on the box for the certificate, which needs to reflect the producer’s name.

“It is important to point out that all PutOn Condoms are produced in accordance with international regulations, hold valid CE certificates and that 95 percent of the condoms available in the Swedish market regardless of the name are manufactured in Asia,” Wendt said in a statement on Thursday.

According to vendor information on the internet, PutOn is sold both in three-packs and together with a vibrator ring, the latter marketed under the product name RockOn. Both products are available for sale in VendOn vending machines, which stock one or both products.

“PutOn Condoms will continue to work with to be the obvious choice for Swedish consumers. This says a lot about a country that claims to invest in entrepreneurs. We will require compensation for what has happened,” said Wendt.

“This is a textbook example of how an agency cannot conduct itself with a serious company. We hope this event will lead to changes in routines at the authority so that others will not encounter similar situations,” he added.

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