What is US FDA Certification?

Any beverage container with a nutrition or health claim must be FDA-certified, according to the Federal Food, Drug, and Cosmetic Act (the “FDCA”). According to the FDCA, if you market your beverage in the United States, regardless of where it is produced, you may be held liable for ensuring that your label claims are accurate and not deceptive. If the FDA finds your claim to be “false and deceptive,” it can require you to stop selling the product with such labeling and, in rare situations, even seek criminal prosecution.

That’s why IAS created a US FDA certification program to help beverage manufacturers get their products on store shelves across the country without violating federal false claims laws. When compared to tackling it alone, our US FDA certification procedure helps you get your product to market faster and with less legal risk.

Regardless of whether a product’s label makes a nutrition or health claim, the producer is responsible for ensuring that its food items comply with all applicable laws and regulations. Working with the FDA on its nutrition claim review and approval process is one of the finest ways for quickly getting a product to market because the FDA is largely responsible for regulating food labeling.

We understand that many beverage manufacturers and importers lack the resources or motivation to go through the FDA’s nutrition claim evaluation procedure. While we are unable to advise on such a strategy, we do acknowledge that each company must develop its own business tactics to achieve US FDA certification.

What are the Fees for US FDA Certification?

The US FDA certification fee is estimated to be around $3,500 USD but can vary depending on the type of product. This US FDA certification cost covers all of your items and labels. In exchange, you will obtain US FDA certification from IAS certifying that your products are consistent with FDA labeling regulations for health and nutrition claims.

How Do I Get US FDA Certification?

To obtain US FDA Certification, send us one representative sample of each beverage product with a nutrition claim (per container type) or a health claim to be certified (per label). Within two weeks of delivery in IAS, each beverage should be in its final packaging and ready to hit the retail shelves.

IAS will review and approve the nutrition or health claim(s) on your product, provide US FDA certification, and then send the certificate to the FDA together with all of the samples we’ve reviewed.

What are the Different Types of US FDA Certification?

US FDA Certification for Medical Devices

Medical device manufacturers and marketers require US FDA certification to demonstrate regulatory compliance in order to reduce business risk, speed time-to-market and improve operational efficiencies. Medical Device FDA Certification helps you get your product to market faster and with less legal risk. Medical Device US FDA certification is a quick and affordable way to demonstrate regulatory compliance in order to reduce business risks, speed time-to-market, and improve operational efficiencies.

US FDA Certification for Cosmetics

If you’re selling cosmetics, your product must have US FDA certification before it can be sold, unless an exception applies. Cosmetic claims, in general, refer to any claim made to promote a cosmetic product for use as a cleansing agent or to impact the structure or function of the human body, whether directly or indirectly (or any part thereof).

US FDA Certification for Drugs

Unless an exception applies, if you are selling medicine, US FDA certification is required prior to marketing. In general, any statement directly or indirectly related to the promotion of a drug for use in diagnosing, curing, alleviating, treating, or preventing a condition is considered a drug claim.

US FDA Certification for Food Items

Unless an exception exists, if you are promoting a product as a food, it must have US FDA certification prior to marketing. In general, this refers to any edible material containing protein, fat, carbs, or other ingredients often found in foods and beverages (excluding alcohol).

US FDA Certification for Supplements

Unless an exception exists, if you are promoting a product as a dietary supplement, it must have US FDA certification prior to promotion. Any vitamin, mineral, herb, or other botanical (including metabolites); amino acid; food product for use by people to supplement their diet by increasing total dietary intake; or concentration, metabolite, component, extract, or combination of any of the above ingredients can apply for US FDA certification.

Duration of FDA Certification

Within 60 days of receiving your application at IAS, FDA will review it. US FDA certification is granted immediately once the review is completed if there are no issues with your product’s health or nutrition claims. If FDA requests additional information or has any questions, IAS will notify you as soon as possible so you can obtain your FDA certificate in a timely manner.

Benefits of US FDA Certification

The following are just some of the many benefits of US FDA Certification:

  • Because you don’t have to file an application for each label that is submitted for approval, you save money and time when it comes to marketing your product.
  • Because we handle all of your company’s paperwork, including filing the FDA certificate, you’ll be able to start marketing your items sooner rather than later.
  • If necessary, we collaborate with the FDA to fix any labeling difficulties and/or accelerate approval of a “novel” nutrition or health claim.
  • You can rest confident that the claim(s) we certify for your product and label will be approved by the FDA to obtain your FDA certificate.

The Process to Achieve US FDA Certification

  1. Select the products and labels that you require US FDA certification. Whether or not your product’s labeling has been pre-approved by FDA, the certification process only applies to beverages with a nutrition or health claim on the label (i.e., prior to our review).
  2. The FDA will receive one representative sample of each product, as well as the product’s complete label(s).
  3. If necessary, we will engage with the FDA directly to resolve any concerns and/or expedite the approval of a “novel” nutrition or health claim to help you obtain your FDA certificate quickly.
  4. We will send you your US FDA certification along with one (1) representative sample of each product for your company’s files once FDA has authorized your product’s label(s).
  5. We’ll preserve the samples and labels for three years after they’ve been issued US FDA certification. Simply fill out our Request Form to get a copy of your certified product label(s). There is no charge to receive the labels for all of your products that have been issued an FDA certificate.
  6. You can also request non-certified additional samples of a product for your company’s records. However, the cost per product label requested is $100.

For more information on US FDA certification, please contact us at info@iasiso.com.