Poland’s Ministry of Health is cracking down on the booming dietary supplement market with stricter rules on advertising, controls, and penalties.
Market Growth and Lack of Oversight
The dietary supplement market has experienced rapid growth in Poland, outpacing the government’s ability to effectively regulate it for years. New regulations aim to address this imbalance.
Since 2007, approximately 29,000 products have been registered as dietary supplements. Between 2017 and 2020, the Chief Pharmaceutical Inspectorate (GIS) received 62,808 notifications regarding the introduction of new supplements.
New Regulations: Advertising and Penalties
The draft legislation from the Ministry of Health focuses on supplements, impacting reporting, advertising, inspections, and penalties. Advertisements will face increased scrutiny, prohibiting claims suggesting a standard diet is insufficient or attributing properties to supplements they do not possess.
Companies previously challenged advertising penalties due to vague wording in existing regulations. The new rules aim to provide clearer definitions and stricter enforcement.
Increased Financial Penalties
The proposed regulations significantly increase potential fines for violations, raising the limit to 100 times the average monthly gross salary, compared to the previous limit of 30 times. This change is intended to deter large companies from non-compliance.
Smaller producers may be discouraged by the potential financial burden, while larger companies will be concerned about increased scrutiny of their advertising practices by Sanepid (the state sanitary inspection).
Digitalization and Timelines
Notifications for new products will be required to be submitted online through the e-Sanepid platform, replacing the previous paper-based system. The GIS will consider a notification submitted on the day it receives a document with a qualified or trusted electronic signature.
The new rules establish specific timelines: 14 days to submit a request for an opinion to a scientific unit or the President of the Office for Registration of Medicinal Products, and 6 months to submit the opinion itself, potentially extending to 12 months in certain cases.
Consequences of Non-Compliance and Repeated Submissions
Failure to meet deadlines will result in a presumption that the proposed classification of the product by the company is incorrect and that the product does not meet the requirements. Companies will also be blocked from submitting new notifications for products with the same qualitative and quantitative composition until an opinion is provided.
This prevents companies from repeatedly submitting applications under different formal variations, streamlining the process and ensuring thorough evaluation.
Impact on the Market
The new regulations will not automatically remove supplements from the market, but will shift the focus to documentation, deadlines, communication with the GIS, and advertising compliance. Products with aggressive marketing, unclear compositions, or misleading claims are most at risk.
Companies operating ethically and maintaining proper documentation should primarily experience increased procedural formality.
