Nutrasource Blog

Your Top Regulatory, R&D, and Testing Questions Answered

Posted by Nutrasource on Mon, Apr 13, 2015

Bringing a product to the next level can be a challenge.  There are many hurdles standing in the way, whether your goal is to support a new claim or re-position your product for a new market.

We've rounded up some of the most common questions we hear from the dietary supplement industry in the hopes that our answers will help you overcome your latest product development challenge.

I’m currently selling in another country and want to bring it to the U.S. market.  What do I need to do?

There are a number of factors to consider when launching a new or existing dietary supplement product in the U.S. marketplace.  First, you need to confirm the product’s regulatory classification as a dietary supplement rather than a food, drink, drug, OTC, etc.  This involves considering the product claims, ingredients and matrix.  Next, brands should ensure the ingredients are generally recognized as safe (GRAS) according to product’s conditions of use (including ingredient quantities), have been in the dietary supplement marketplace prior to October 15, 1994, or have been accepted by the U.S. Food and Drug Administration (FDA) as a New Dietary Ingredient (refer to Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d) for premarket review for safety data and other information required by law).

You should also have reasonable expectation of safety under conditions of use communicated on the product label and ensure that the product will be manufactured according to Good Manufacturing Practices (GMPs) as per Part 111 of 21 CFR for manufacturing, packaging, labelling or holding operations for dietary supplements.

Another important aspect to review before bringing a supplement into the U.S. market is labelling and advertising.  You should ensure all requirements of the Dietary Supplement Health and Education Act (DSHEA) and FDA regulations are met.  You should also check the claim substantiation file for label claims to avoid marketing products that are adulterated or misbranded as the Federal Trade Commission (FTC) and FDA are responsible for compliance and enforcement.  Furthermore, do not label a product like it will treat, prevent or cure a specific disease or condition.  This could raise red flags with the FTC and FDA.

When making these critical decisions, it helps to enlist an experienced regulatory consultant or team to help you figure out which, if any, gaps you need to fill in order to comply with U.S. regulations.  Hiring an expert to review your product profile and recommend next steps will expedite the time it takes to bring it to market.

I Want to Conduct a clinical trial to support my product’s claim.  How do I get started?

There are many different factors involved in designing and running a clinical trial and no two companies or products are the same, so to get started we recommend connecting directly with our clinical research team.  They will work with you to assess your needs and business goals, your product profile and then either provide you with a quote or a product development plan.

Curious about hiring a contract research organization?  Find out what questions you should be asking.

My new product formulation contains ingredients A and B. I have testimonial evidence that it works for health condition Z. How can I Support my Product's Claims?

Gathering and interpreting scientific research is one of those things that is best left to the pros.  Getting caught with evidence that is sub-par, whether intentional or not, can result in serious consequences for your brand (not to mention your bottom line).  One thing you can do is enlist an experienced team of scientists to conduct a systematic scientific literature review investigating the safety and efficacy of the ingredients.  These results can tell you whether the dose, dosage form, source material, route of administration and potency of key bioactives was not only safe but also efficacious for the health effect of interest.  Once you have the full set of data in front of you, you can figure out if there is enough to back up the product’s claim or if a new clinical trial is warranted.

What are the testing requirements for dietary supplements in the U.S. and Canada?

In the U.S., according to the regulations set by the Food and Drug Administration (FDA) (921 CFR 111), the responsible party (typically the manufacturer) must ensure the products are in compliance with current Good Manufacturing Practices (GMPs).  At least one appropriate test must be used to determine the identity of each ingredient contained in the product.  The lot must also be tested for contaminants (e.g., heavy metals, mercury, PCBs), potency and quantity of active compounds at all points along the manufacturing process where necessary to confirm that the products maintain quality.  It is up to the responsible party to ensure that specifications are set for each control point and to maintain adequate documentation explaining why these specifications will ensure a high quality product free from adulteration.  According to the GMPs, the test methods used must also be appropriate and scientifically valid.

In Canada, the product licence holder is responsible for ensuring the quality of their natural health product, and this information is required for the Product Licence Application (PLA) (the pre-market approval process required to sell an NHP in Canada).  If the product or ingredient has a current Natural and Non-Prescription Health Products Directorate (NNHPD) monograph, it may detail specifications that are relevant to the product.  When establishing product specifications, the Natural Health Products Ingredients Database (NHPID) should also be checked for additional specifications that may be listed for the ingredient/product.  The Finished Product Specification Form assists the licence holder with the quality requirements set out in the Natural Health Product Regulations and includes sections that allow you to identify which parameters were tested and how they were tested.  Parameters include contaminants, stability and solvent residues, among others.  In addition, the following tests should be conducted: physical identity (for all product types), medicinal ingredient identity (for all ingredients in the raw material or finished product stage), quantity (for most ingredients, enzymes, vitamins, minerals, amino acids, probiotics and lutein), potency for standardized extracts (for most constituents, enzymes, vitamins, minerals and amino acids, lutein and zeaxanthin), and purity (microbial and chemical) for certain products.

When in doubt, enlisting a consulting firm or laboratory familiar with dietary supplement testing can help clarify the regulations so that you can be confident you’re conducting the right tests using the proper methods.

To learn more about dietary supplement regulatory compliance, clinical research, or analytical testing, contact us today.

Topics: Product Testing & Certifications, Clinical Trials, Claims, Regulatory, Dietary Supplements/Natural Health Products