What permits do I need to sell dietary supplements?

Food supplements are a highly regulated industry today, so it's extremely important to know and comply with these regulations, otherwise you could face many problems. If you manufacture and/or sell dietary supplements, this is for you 😉.

We can consider that the regulation exists in three main systems, which are: General Health Law, Regulation of Health Control of Products and Services and Regulations of the General Health Law in the Area of Advertising.

One of the reasons why they are so regulated, in addition to the impact they clearly have on our health, is the recent proliferation of “miracle products”, so it becomes very very important to know what we can consider as a dietary supplement.

The General Health Law defines the latter as those herbal products, plant extracts, traditional foods, dehydrated or fruit concentrates, added or not, with vitamins or minerals, that can be presented in pharmaceutical form and whose purpose of use is to increase total dietary intake, supplement it or supplement any of its components. Some very common examples are proteins, capsules with oils, probiotics, and many others.

It is essential to understand their purpose well, so as not to fall into the category already mentioned and avoid problems, since a very common case is that therapeutic effects specific to medications are attributed to them, which happens when the purpose already indicated is ignored.

But hey, what should I do if I don't want to have problems with the Federal Commission for Protection against Health Risks a.k.a COFEPRIS? The answer is simple, you must do the following:

• Submit your operating notice, duly filled out.
• Check that the product labeling complies with the corresponding regulations.
• It is recommended to carry out a procedure known as a “consultation for the classification of a product as a dietary supplement”.
• If you advertise your products, you'll need to have an advertising permit.
• We must refrain from using prohibited ingredients such as hormones or substances with pharmacological action.

Practically complying with all of the above, you are on the other side, that is, you should not have any problems with authority.

Now, what if I don't meet any of these requirements? Well, it depends on the fault you commit, but the consequences can range from the confiscation of your products, the closure of the establishment, suspension of activities and even large fines.

So now you know, if you want adequate regulatory compliance, don't hesitate to contact us.

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