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The label is often one of the first things a consumer sees about your product, whether it is the physical label in-store or a digital rendering on your website.  Many companies do not realize that the product label is heavily regulated.  This includes mandatory labeling statements, accuracy of information and claims, positioning of information, technical formatting, disclaimers, cautions and warnings, and much more.  Labeling mistakes can be very costly, especially if they are severe enough to require reprinting or draw a regulator's eye.  A common example of this is not labeling allergens correctly or at all, which would require a Class I Recall.

Both the FDA and the FTC require that supplement manufacturers’ claims are truthful and adequately substantiated.

1. Advertising must be truthful and not misleading.

2. Advertisers must have competent and reliable scientific evidence substantiating all product claims.

We develop compelling and compliant claims based on your formulation, while creating a claim dossier to satisfy the scientific evidence requirement.  Read through the FTC's  Health Products Compliance Guidance.

Anything say about your product is considered by regulators as an extension of the product label.  FDA and FTC share jurisdiction of internet advertising for dietary supplements which includes website, blog, store page, product reviews, social media accounts and posts, endorsements and testimonials, and all other digital advertising.  FTC also regulates print advertising.    

Additionally, there are several types of claims that can be legally made for natural products, but each one has specific rules that must be followed:   

Structure/function, nutrient content, Made in the USA, endorsements and testimonials, specialty claims, and much more.

Are you prepared for regulators to review your content?

We review records of incoming ingredients, in-process materials, and finished products to ensure accuracy, quality, identity and purity standards.

We are proudly partnered with NOVA Regulatory Canada Inc. who offer a complete turnkey solution to get your U.S. product effectively and compliantly on the Canadian market.  

NOVA's expertise is second to none when it comes to Natural Health Products, Supplemented Foods, Site Licensing, Veterinary Health Products, Cosmetic Products, OTC-Non-Prescription Products (Category 4) and Cannabis Products.  

Unique and branded ingredients provide a distinct advantage in the current environment.  However, before launching you must ensure that the ingredient meets the statutory definition of a Dietary Ingredient and is also not a New Dietary Ingredient (NDI) requiring premarket notification to the FDA.  

Who doesn't want to get in on the CBD/hemp action?  The popular ingredient is the topic of much debate from regulators, Congress, industry and consumers, but it is here to stay.  There are many ways to use the ingredient and stay out of state and federal regulator's crosshairs. 

If you want to sell your dietary supplement on Amazon, you must comply with all federal, state, local laws, and Amazon policies applicable to those products and product listings, including their updated policy. 

We provide records review and guidance documentation for 21 CFR 111, 21 CFR 110, 21 CFR 117.

Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm.  The California Attorney General's Office enforces Proposition 65. and any district attorney or city attorney may also enforce Proposition 65. In addition, any individual "acting in the public interest" may enforce Proposition 65 by filing a lawsuit against a business alleged to be in violation of this law. Unfortunately, this happens all too often and penalties for violating Proposition 65 by failing to provide notices can be as high as $2,500 per violation per day. Feeling lucky?

Not sure where to start or how to go about navigating compliance issues?  Let's talk and find the best path forward.  We can begin with an obligation and cost free consult to get to know you and your business needs.

Gluten free, Organic, Non-GMO, 100% Natural, Kosher, Halal, Green/Recyclable, the list hoes on.  Every specialty claim and certification has requirements to be met before making a claim or bearing a seal.  Make sure your brand meets the requirements.

Defined by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (21 CFR 117.3), a Preventive Controls Qualified Individual (PCQI) is a qualified individual who has completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.” An individual achieves PCQI certification, they’re responsible for performing or overseeing the following tasks:

• Preparation of the food safety plan.
• Validation of the preventive controls.
• Review of records.
• Reanalysis of the food safety plan.

Natural products and consumable goods have registration and submission obligations to fulfill.  To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring, among other things, that food facilities register with FDA.  This includes facilities that manufacture, pack, or hold dietary supplements for U.S. consumption.

The Federal Food, Drug, and Cosmetic Act  requires that the manufacturer, packer, or distributor who wishes to market a dietary supplement notify FDA regarding the statement(s) on the label or in the labeling of its product that meets the statutory definition of a structure/function claim.

Additionally, depending on your product type, there are other registration and submissions to consider.

Have an idea for a product but don't know where to start?  We partner with reputable suppliers and manufacturers to help get your idea to market.  From conceptualization, formulation, labeling, and compliant marketing and everything between, we will be there for you.