Product Licensing/Registration (Canada, USA, EU)
NHPs are a subset of drugs and require a pre-market licence. NHP Consulting can help our clients obtain product licences for any natural health product, ranging from relatively simple (Class I and II) applications to and also complex traditional and non-traditional products containing novel ingredients or making health claims new to the industry (Class III). In order to achieve the product licence (NPN), documentation must be presented to Health Canada proving efficacy, safety and quality of the product, and the manufacturing and importing facilities must be recognized (licensed) by Health Canada as Good Manufacturing Practice (GMP) compliant.
NHP Consulting has submitted over 40,000 NPN applications on behalf of manufacturers, distributors and retailers of natural health products. Our team is the best in the industry at creating regulatory submissions that allow you to position your products the way you want on the market within your company’s time-frames for launch. Contact us to find out why we are Canada’s leading consulting firm for the licensing of natural health products.
USA DIETARY SUPPLEMENTS
The United States (US) Food and Drug Administration (FDA) regulates dietary supplements by way of the Dietary Supplement Health and Education Act (DSHEA), under the general umbrella of “foods.” Except in the case of a “new dietary ingredient,” (see below), dietary supplements are not approved by the FDA, but every manufacturer/distributor must assemble and hold evidence that the products they handle are safe, effective, and labelled according to FDA regulations. If claims are made on the product labels, manufacturers/distributors must file a notification of the claim text with the FDA no later than 30 days after introducing the dietary supplement to the market.
NHP Consulting can provide you with a comprehensive product compliance plan for your dietary supplement in the USA. We will review your product labels, file any required FDA Notification on your behalf, and prepare an evidence package to substantiate your label claims for you to retain on file.
NEW DIETARY INGREDIENT (NDI) NOTIFICATION (USA)
An ingredient is considered a “new dietary ingredient” if it was not marketed in the United States prior to October 15, 1994. To have a new dietary ingredient approved for use in a contemporary dietary supplement, the manufacturer/distributor must demonstrate safety to the FDA. This demonstration takes the form of a new dietary ingredient (NDI) notification, and an approval must be received prior to placing a product containing the NDI on the US market.
While there is no official list of dietary ingredients that were on the market prior to October 15, 1994, NHP Consulting has a number of resources to help appropriately classify your ingredient. Our team can confirm if a NDI notification is required for any ingredient in your product, prepare the NDI notification paperwork, and liaise with the FDA after submission.
EU Food Supplement
In the European Union (EU), food supplements are regulated on a community-wide level under Directive 2002/46/EC., and each individual Member State implements additional regulations where they deem appropriate.
Within the EU Directive itself, there are restrictions on which vitamins and minerals can be used in food supplements, including their sources. There are also many ingredients which are further restricted through individual Member State regulations, including specific limits on vitamins and minerals as well as prohibited ingredients, including certain botanicals. Health claims and nutrition claims are regulated at the EU level and are permitted on food supplement labels, but must comply with specific requirements.
Food supplement registration requirements differ between Member States. For example, there is no requirement for food supplements to be registered or authorized for sale in the UK or the Netherlands as long as products comply with the associated legislation. However, Member States such as Belgium, France, Germany, Italy and Spain each require separate notification procedures for food supplements to the competent authorities, with varying governmental fees associated.
The varying requirements makes product launches into individual EU Member States daunting to the outsider. NHP Consulting offers a wide range of services to help guide companies through the various labelling, marketing and product registration processes that exist throughout the European Union, including formula assessments, product registrations, and translations of label text into local European languages.