Ensuring Regulatory Compliance When Bringing a Product to Market

    Getting Regulatory Right is Brand Insurance

    Regulation Concept with Wooden Blocks high quality and high resolution studio shoot

    The nutraceuticals market is experiencing a sustained period of growth fueled by consumers who are more focused than ever on improving their personal health, looking for dietary supplements to help them meet their daily nutritional requirements. This introduces great opportunity for marketers of nutraceutical supplements. As they bring new products to market to meet consumer demand, it is critical that they comply with all regulatory requirements to protect consumers and themselves. 

    Nutraceutical Industry Regulations–1994 to 2023

    Thirty years ago, regulations in the nutraceutical space didn’t exist, but then in 1994 the Food and Drug Administration introduced the Dietary Supplement Health and Education Act (DSHEA), which set the foundation for what a dietary supplement is and how it could be marketed legally. 

    In 2007, the FDA established Current Good Manufacturing Practices Rule as part of DSHEA. This requires that manufacturers employ certain activities in manufacturing, packaging, labeling, and storage of dietary supplements to ensure that the supplement contains what it lists on the label and is not contaminated with harmful or undesirable substances (1).  

    This year, mandatory compliance with the U.S. Department of Agriculture Bioengineered Regulation went into effect (2). It requires manufacturers, importers, and retailers to identify genetically modified organisms (GMO) that are included in their products. Starting Next year, supplement manufacturers will also have to indicate if there is any sesame in their product, due to its potential effect as an allergen. It was added as the 9th major food allergen under the FASTER Act of 2021 passed by Congress (3). 

    The FDA is also currently discussing the introduction of a Mandatory Product Listing for supplements. If this is enacted, any product being marketed as a nutraceutical supplement would have to be included on the FDA’s website listing of approved products before being sold to the public.  

    Finally, the definition of the word “healthy” with regards to supplements may also be revised by the FDA. Not updated since the introduction of the DSHEA act, the FDA announced earlier this year that they may redefine what the word “healthy” means to match current nutritional science. The new definition would reflect what we now know about sodium, added sugars, and other ingredients. 

    Ensuring Regulatory Compliance

    One of the keys to remaining compliant with the growing list of governmental regulations is to not make false or misleading efficacy claims. In most cases, inaccurate claims aren’t made with malicious intent. There are established guidelines on what supplements can and cannot do, and manufacturers can sometimes become overenthusiastic describing how consumers will benefit from their product. 

    Organizations can’t market a dietary supplement by saying it is intended to diagnose, treat, cure or prevent any disease. If it were to do that, the supplement would be categorized as a drug/medicine. In other cases, certain benefits can be exaggerated. For example, a company in the sports nutrition market might say that their products can improve performance, or they might make unsubstantiated claims that taking their product can help people burn fat and lose weight. 

    Product efficacy is a topic that should be managed by your product development team. Before making any kind of claim, it is important to connect with regulatory lawyers to discuss what will be allowed and which claims would open you up to regulatory scrutiny. The lawyer you work with should specialize in the nutraceutical space and have extensive experience in the market, so that they know about all requirements that will impact your product.  

    What is more palatable to the FDA are making what are known as “structure/function” or “nutrient content” claims, which describe how the supplement is intended to affect the normal function of the human body. For example, stating that “calcium builds strong bones.”  

    Compliant labels

    Another important component of regulatory compliance comes in the development of nutraceutical labels. If you work with a qualified contract manufacturer, they will provide guidance for your product formulation, outlining everything that must be declared on the label to ensure compliance. 

    Formatting of the label is also a key consideration. Each label must contain the company’s information, include mandatory listings of nutrients identified by the FDA, directions on how to take the supplement, and serving sizeall information that makes it clear to an everyday consumer that they know what they are buying and what it should do for them. 

    Expanding Globally

    Manufacturers who sell their product outside the U.S. face additional regulatory challenges. Structural/function claims that are accepted by the FDA in the U.S., may open a manufacturer up to additional scrutiny in other regions around the world. Many ingredients that are considered supplements in the U.S. may be identified as medicines in another country, which means the product will have to comply with a separate set of regulations. 

    There are some ingredients that are not even allowed in other countries. Internal experts should know when issues like this arise, but contract manufacturers can also advise on what to look out for in each country you are entering and provide guidance on appropriate ingredient substitutes that are allowed in those countries. 

    Regulatory shouldn’t be seen as an adversary. They are on everyone’s side and want to encourage innovation, helping manufacturers make products in the best way possible while avoiding regulatory challenges. Qualified contract manufacturers stay on top of all regulatory requirements, trending ingredients and new products entering the market. They are always looking out for their customers and work with regulatory experts to provide an invaluable service that helps dietary supplement companies save money and their reputation. 

    References

    1. FDA, https://www.fda.gov/food/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements/backgrounder-final-rule-current-good-manufacturing-practices-cgmps-dietary-supplements, Accessed 11/29/22 
    2. USDA, “BE Frequently Asked Questions – General”, https://www.ams.usda.gov/rules-regulations/be/faq/general#:~:text=At%207%20CFR%2066.13(c,in%20compliance%20with%20the%20Standard., Accessed 8 December 2022 
    3. FDA, “Food Allergies”, Updated 22 October 2022, https://www.fda.gov/food/food-labeling-nutrition/food-allergies#:~:text=Sesame-,Under%20the%20FASTER%20Act%20of%202021%2C%20sesame%20is%20being%20added,a%20natural%20flavoring%20or%20spice, Accessed 8 December 2022