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  • Writer's pictureReguloo

What are the risks of health non-compliance?

Updated: Aug 22, 2022

Whether you are a community pharmacist, a cosmetics manufacturer, a distributor of health products or food supplements, you are all subject to a very strict regulatory framework governing health products.

The objective is to protect the consumer, and prevent excesses.

This is why, depending on your status (distributor, manufacturer, holder of the health product, etc.), your obligations are different.

Very often, it is difficult to convince people who develop, create, promote and market their product that not everything is possible. Here is an example, it is forbidden to say that a drug contains organic active ingredients , even if this is true.

This may seem quite surprising and yet the reason is that a drug should not be chosen by consumers on the criterion of the organic quality or not of its active ingredients but rather in relation to its effectiveness.

Sometimes the long explanatory speeches are quite complicated to make understood and this is why the legislators have defined penalties in the event of non-compliance with the regulations in order to deter the desire to not respect the guidelines.

There are different ways for the authorities to inspect a manufacturer, distributor, or registrant.

They can take a sample or sample a product for analysis. When they observe an infraction, the investigators can proceed to take a sample of goods or a copy of it, intended to serve as evidence, i.e. to materialize the breach or infraction. (art. L. 512-12 of the Consumer Code). But it is not always possible to identify the infraction by a simple statement, to know precisely the composition of a product or to ensure that it meets the requirements of the regulation, some products must be subjected to a physical, mechanical or chemical analysis. For this reason, agents can take samples to have them analyzed by a laboratory (art. L. 512-23 of the Consumer Code).

Analyses also make it possible to verify the effectiveness of the claims made on the packaging of certain products, for example "organic", or to ensure that a product is safe (absence of prohibited ingredients in cosmetics).

What measures can the authorities take?

- The consignment is a provisional measure that allows the administration, pending the results of the necessary controls, to prevent the marketing of products that are likely to be falsified, corrupted or toxic, or unfit for consumption, to be non-compliant with the laws and regulations in force and to present a danger to the health or safety of consumers or to be counterfeit (art. L. 512-26 and following of the Consumer Code).

Seize non-conforming goods, particularly in the event of flagrant falsification, or when they are recognized as falsified, corrupted or toxic, or unfit for consumption, or products, objects or appliances suitable for falsification or recognized as not conforming to the laws and regulations in force and presenting a danger to the health or safety of consumers, or as counterfeits (art. L. 512-29 of the Consumer Code)

-Use an assumed identity to monitor Internet sites. For the monitoring of the sale of goods and provision of services on the Internet (Art. L. 512-16 of the Consumer Code and Art. L. 450-3-2 of the Commercial Code), in order to be able to make a purchase like any other consumer and thus "test" the procedure to its conclusion. This is particularly useful to verify the information given by the seller to the consumer.

When making a purchase, the investigator can thus verify that, in accordance with the Consumer Code, the Internet site does indeed indicate to the buyer the delivery date of the good or if it does indeed provide a withdrawal form.

When subscribing to a video-on-demand service on the Internet, the investigator can thus verify the allegations on the commercial offer made to the consumer (availability of videos, free month, essential characteristics of the offer).

-Delaying the disclosure of their capacity as an investigator. When the proof of the infringement or breach depends on it, the investigators can start their investigations without immediately indicating their investigator status (art. L. 512-7 of the Consumer Code, art. L. 450-3-2 of the Commercial Code).

For example, during an investigation of a company's commercial practices, this method makes it possible to verify whether the professional actually respects his commitment to reimburse twice the difference if the consumer finds a cheaper price elsewhere.


They vary according to the sanctions provided for and the particularity of each inspection.

1. Determining the consequences

Each legal text that defines an obligation or a prohibition also defines a sanction in the event of failure or infringement of the latter.

Example-The trader who does not display the prices of his products is liable to an administrative fine of up to €3,000 for a natural person and €15,000 for a legal person (art. L. 113-3-2 of the Consumer Code).

-The distributor of cosmetics who indicates an unproven claim is liable to a criminal fine of up to €300,000 and/or a prison sentence of 2 years for misleading commercial practices (art. L. 132-2 of the Consumer Code).

-In case of non-compliance with mandatory payment terms between professionals, the offender may be sentenced to an administrative fine of up to €75,000 for an individual and €2 million for a legal entity (art. L. 441-6 and L. 443-1 of the Commercial Code).

The law determines the nature of the sanctions (e.g., fine or imprisonment) and their maximum amount. Of course, these ceilings are not systematically applied and the consequences are decided according to the circumstances of the case and proportionate to the seriousness of the facts observed.

These suites fall into three categories:

-educational: warning,

-corrective: administrative police measures, including injunctions under summons (i.e., implementation of a procedure before a judicial court),

-Some are decided and implemented by the authority itself: warnings, injunctions and fines. For others, the authority has the power to initiate sanction procedures but does not take the decisions itself. For certain administrative police measures, it implements the adversarial procedure and submits the final decision to the prefect or minister for signature (a decision that can be referred to the administrative judge). In the case of summonses and the transmission of a report to the Public Prosecutor's Office, it is the judicial courts (civil or criminal respectively) that make the decisions. Finally, the DGCCRF's evidence or investigation reports concerning anti-competitive practices are transmitted to the Competition Authority, which may take them up; if it does not take them up, the DGCCRF continues the procedure itself.

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