Gareth Sheridan's Nutriband was fined by US government

Irish Examiner

4 days ago

A cease and desist agreement between presidential hopeful Gareth Sheridan's Nutriband company and the US government in 2018 included a $25,000 fine for the businessman.
According to the 2018 document, Nutriband never obtained authorisation from the Food and Drug Administration (FDA) before marketing its products — transdermal patches for the delivery of vitamins and drugs — in the US.
Mr Sheridan told Hot Press in an interview last week that the company had received advice that the products would be treated as medical supplements rather than devices and that this had led the Securities and Exchange Commission (SEC) to investigate Nutriband. In late 2018, a cease and desist order was agreed between the two sides, which Mr Sheridan called 'a wake-up call'.
The terms of the agreement saw a $25,000 fine each levied against both Mr Sheridan, then the company's CEO, and his business partner Serguei Melnik.
The SEC investigation said that according to the company's annual reports for the fiscal years ending 2017 and 2018, Nutriband had no revenue and had incurred a net loss of approximately $2.7m as it developed. In that time, Mr Sheridan and Mr Melnik were its two employees.
The SEC's investigation found that Nutriband's transdermal patches consist of a drug and a delivery device, and such drug-device combination products would require FDA approval.
It said that six Nutriband public filings with the SEC "contained misleading statements about the FDA's jurisdiction over its products or failed to state that the company's products could not be marketed in the US without FDA approval" and that various filings had "mischaracterised the company's products as 'dietary supplements' not subject to FDA regulation and approval".
In July 2018, the company retained an FDA-specific lawyer who "provided an opinion stating that Nutriband's products are regulated as drugs by the FDA" and 'must receive market approval before being sold in the US, which may significantly limit Nutriband's projected sales targets".
The document said that both men must cease their previous descriptions of the products and each pay $25,000 to the US government.
Former presidential candidate Sean Gallagher is a former chairman of the company, but resigned in January 2022, with his resignation letter citing in part a €154,000 spend on a corporate box for Orlando Magic basketball games.
Housing developments
Mr Sheridan has also said today that his mother opposed a housing development over concerns it would 'become social housing' at the 'behest of her employer'. This is despite the fact that the project in question was being developed by her employer.
Ann Sheridan, who was a director of Mr Sheridan's company Nutriband when it was established in 2012, is listed as a director of several companies involved in property development.
However, Mr Sheridan has told the Irish Examiner that this mother works in accounts and administration for a property developer and is not a developer herself.
Mr Sheridan has said that his platform for the presidency will partly be based on housing. He said that the questions raised by the Irish Examiner would spur that desire.
"Rather than deter me from making housing one of the key elements of my campaign, this merely underscores the dire need to address this kind of practice and conduct within the areas of planning and property development, which serves to slow down the provision of housing and escalate costs."