Nutritional supplements arise from the need to consume more nutrients or other substances such as vitamins, minerals, fatty acids, proteins, probiotics, herbs, mushrooms, and others for a better quality of life or to address a specific deficiency. These supplements come in various forms such as tablets, powders, liquids, gummies, ampoules, oils, and many more.

In recent years, we have witnessed a growing focus on health and wellness. As a result, people have become more aware, leading to changes in lifestyle and eating habits. They now seek different ways to consume products that benefit their daily performance and overall quality of life. This demand has fueled market growth, where consumers aim to prevent aging, address health concerns, or prevent illnesses.

Thanks to the wide variety of ingredients and the commercial boost this sector has received, companies offer numerous options tailored to the preferences and needs of consumers. Awareness and interest in this subject continue to rise, and companies are constantly conducting research to innovate and provide a product catalog that meets the specific needs of individuals.

Although producing supplements may seem easy with ample opportunities for growth, the necessary requirements for product manufacturing should not be overlooked. There is no global regulation outlining the requirements for marketing dietary supplements. However, that does not mean they are exempt from regulations.

The sales conditions for supplements vary depending on the country where the sale will take place. Some countries have strict regulations regarding the safety and efficacy of products, while others are more flexible. Some general considerations for producing and distributing a dietary supplement can be highlighted.

First, it is important to note that some countries require the product to be registered and authorized before it can be marketed. This refers to submitting documentation of the product's formulation, safety, and quality. This is a crucial step because most supplements promise health and wellness improvements, making it a sensitive issue that must be authorized to ensure consumer safety.

The second key point for the production and sale of supplements is labeling. It could be considered one of the most important aspects, as it reflects the information that interests consumers, such as ingredients, quantities, usage instructions, and warnings. As with other products, the labeling requirements depend on the country where the product will be sold.

It's also worth noting that some countries have specific requirements for the facilities where the product is manufactured. This is closely tied to protecting public health and safety during the production processes of dietary supplements.

Another step that may be required for approving the sale of dietary supplements is testing and certifications. These tests are conducted on the final product formula and must demonstrate the product’s safety and efficacy. Certifications vary, and laboratory tests can also be carried out on the ingredients and manufacturing processes.

Last but not least are regulations regarding additives. For certain ingredients or additives, some countries require compliance with specific standards. These again stem from concerns about consumer health.

To give an example, let's use the case of the United States to illustrate the types of regulations that different countries may have. The agency responsible for regulating these products is the U.S. Food and Drug Administration (FDA), which treats dietary supplements as food. The FDA requires that any site manufacturing, storing, or physically handling these products be registered with the FDA. Just like food, supplements must have carefully designed labels that meet FDA requirements, with special attention given to health claims, as these could classify the product as a drug, complicating or even preventing its entry and sale in the United States.

Alt

hough the FDA does not have the authority to approve the safety and efficacy of supplements before they are sold to the public, once the product is on the market, the FDA can conduct reviews and issue warnings. If a product does not comply with regulations, the FDA can request its removal from the market. This is why companies are responsible for complying with safety regulations in the United States.

Regarding labels, the FDA ensures that the information provided is clear and complete so that cons

umers can make informed decisions about purchasing the product.  

On the other hand, private sector organizations such as NSF offer dietary supplement management system certifications as well as specific product certifications. These certifications aim to ensure compliance with Good Manufacturing Practices and the accuracy of content claims on labeling. NSF certifications for supplements are based on the NSF/ANSI 173 standard, making it the only certification in the U.S. that evaluates nutritional supplements.

NSF evaluates nutritional supplements through laboratories worldwide that specialize in verifying product identity, ingredients, and potential contaminants. This evaluation ensures that ingredients meet the requirements to be considered pure and match their identity.

In addition to laboratory tests and formula evaluations, NSF conducts annual audits and frequently analyzes certified products to ensure they continue to meet the necessary compliance requirements to maintain certification. One way to retain certification is by seeking guidance, which you can find at CORE, where we can assist you in staying up to date and complying with NSF requirements.

Another certification offered exclusively by NSF is the Certified for Sport® certification. This ensures that nutritional supplements do not contain substances banned by major sports organizations. This certification benefits individuals involved in sports by allowing them to make better-informed decisions based on the information presented by products.

One of the privileges of obtaining the Certified for Sport® certification is its recognition by various sports organizations and anti-doping agencies such as the USADA, MLB, NHL, and CFL. Similarly, several professional sports leagues support the consumption of products with this certification because of the reduced risks associated with using them.

It's important to note that products seeking Certified for Sport® certification are not exempt from NSF/ANSI 173 or NSF 229 certifications, as these certifications analyze basic standards that any dietary supplement must meet.

Regarding regulations, marketing a product like dietary supplements is highly complex and varies depending on the country where the product will be distributed. However, this does not mean it's impossible, as we can help you through the process. Contact us for support with your project and to ensure you meet all the regulations required by the market you wish to target.

Nutritional supplements arise from the need to consume more nutrients or other substances such as vitamins, minerals, fatty acids, proteins, probiotics, herbs, mushrooms, and others for a better quality of life or to address a specific deficiency. These supplements come in various forms such as tablets, powders, liquids, gummies, ampoules, oils, and many more.

In recent years, we have witnessed a growing focus on health and wellness. As a result, people have become more aware, leading to changes in lifestyle and eating habits. They now seek different ways to consume products that benefit their daily performance and overall quality of life. This demand has fueled market growth, where consumers aim to prevent aging, address health concerns, or prevent illnesses.

Thanks to the wide variety of ingredients and the commercial boost this sector has received, companies offer numerous options tailored to the preferences and needs of consumers. Awareness and interest in this subject continue to rise, and companies are constantly conducting research to innovate and provide a product catalog that meets the specific needs of individuals.

Although producing supplements may seem easy with ample opportunities for growth, the necessary requirements for product manufacturing should not be overlooked. There is no global regulation outlining the requirements for marketing dietary supplements. However, that does not mean they are exempt from regulations.

The sales conditions for supplements vary depending on the country where the sale will take place. Some countries have strict regulations regarding the safety and efficacy of products, while others are more flexible. Some general considerations for producing and distributing a dietary supplement can be highlighted.

First, it is important to note that some countries require the product to be registered and authorized before it can be marketed. This refers to submitting documentation of the product's formulation, safety, and quality. This is a crucial step because most supplements promise health and wellness improvements, making it a sensitive issue that must be authorized to ensure consumer safety.

The second key point for the production and sale of supplements is labeling. It could be considered one of the most important aspects, as it reflects the information that interests consumers, such as ingredients, quantities, usage instructions, and warnings. As with other products, the labeling requirements depend on the country where the product will be sold.

It's also worth noting that some countries have specific requirements for the facilities where the product is manufactured. This is closely tied to protecting public health and safety during the production processes of dietary supplements.

Another step that may be required for approving the sale of dietary supplements is testing and certifications. These tests are conducted on the final product formula and must demonstrate the product’s safety and efficacy. Certifications vary, and laboratory tests can also be carried out on the ingredients and manufacturing processes.

Last but not least are regulations regarding additives. For certain ingredients or additives, some countries require compliance with specific standards. These again stem from concerns about consumer health.

To give an example, let's use the case of the United States to illustrate the types of regulations that different countries may have. The agency responsible for regulating these products is the U.S. Food and Drug Administration (FDA), which treats dietary supplements as food. The FDA requires that any site manufacturing, storing, or physically handling these products be registered with the FDA. Just like food, supplements must have carefully designed labels that meet FDA requirements, with special attention given to health claims, as these could classify the product as a drug, complicating or even preventing its entry and sale in the United States.

Alt

hough the FDA does not have the authority to approve the safety and efficacy of supplements before they are sold to the public, once the product is on the market, the FDA can conduct reviews and issue warnings. If a product does not comply with regulations, the FDA can request its removal from the market. This is why companies are responsible for complying with safety regulations in the United States.

Regarding labels, the FDA ensures that the information provided is clear and complete so that cons

umers can make informed decisions about purchasing the product.  

On the other hand, private sector organizations such as NSF offer dietary supplement management system certifications as well as specific product certifications. These certifications aim to ensure compliance with Good Manufacturing Practices and the accuracy of content claims on labeling. NSF certifications for supplements are based on the NSF/ANSI 173 standard, making it the only certification in the U.S. that evaluates nutritional supplements.

NSF evaluates nutritional supplements through laboratories worldwide that specialize in verifying product identity, ingredients, and potential contaminants. This evaluation ensures that ingredients meet the requirements to be considered pure and match their identity.

In addition to laboratory tests and formula evaluations, NSF conducts annual audits and frequently analyzes certified products to ensure they continue to meet the necessary compliance requirements to maintain certification. One way to retain certification is by seeking guidance, which you can find at CORE, where we can assist you in staying up to date and complying with NSF requirements.

Another certification offered exclusively by NSF is the Certified for Sport® certification. This ensures that nutritional supplements do not contain substances banned by major sports organizations. This certification benefits individuals involved in sports by allowing them to make better-informed decisions based on the information presented by products.

One of the privileges of obtaining the Certified for Sport® certification is its recognition by various sports organizations and anti-doping agencies such as the USADA, MLB, NHL, and CFL. Similarly, several professional sports leagues support the consumption of products with this certification because of the reduced risks associated with using them.

It's important to note that products seeking Certified for Sport® certification are not exempt from NSF/ANSI 173 or NSF 229 certifications, as these certifications analyze basic standards that any dietary supplement must meet.

Regarding regulations, marketing a product like dietary supplements is highly complex and varies depending on the country where the product will be distributed. However, this does not mean it's impossible, as we can help you through the process. Contact us for support with your project and to ensure you meet all the regulations required by the market you wish to target.