According to a recent industry report from Statista, the value of the US dietary supplement market is expected to reach $70 billion, which would represent a significant increase compared with 2022 when the market was valued at approximately $43 billion.1
As international dietary supplement and nutraceutical brands consider entering or expanding into the US market — including manufacturing and distribution — being aware of and understanding the latest industry and regulatory updates is vital to achieving success in this highly competitive and evolving space.
Nathan Cox, Vice President of Strategic Sales at Lief Labs, reports.
Key 2024 US regulatory and policy updates
As the dietary supplement and nutrition industry continues to work toward increasing quality, integrity, safety and consumer transparency, 2024 brought several important regulatory and policy changes in the US.
What follows is an overview of some of the key updates that will have the most significant impact. Global dietary supplement brands who are manufacturing and distributing products in the US should take note.
United States Department of Agriculture (USDA): strengthening organic enforcement (SOE)
The USDA implemented new rules on 19 March 2024, which amend the USDA’s organic regulations to strengthen the oversight and enforcement of the production, handling and sale of organic agricultural products.2
According to the USDA, these amendments protect integrity throughout the supply chain and build consumer and industry trust in the USDA organic label by strengthening control systems, improving farm to market traceability and enforcing regulations.
One of the primary requirements included in these SOE rules includes the use of electronic NOP Import Certificates to improve the supervision and traceability of organic agricultural products imported into the United States.3
Following the recent implementation, the SOE rules require that any shipment imported into the US (claiming to be an organic agricultural product) needs to comply with an NOP Import Certificate issued by an accredited certifying agent in the USDA’s Organic INTEGRITY Database.
As the nutrition industry has been working to quickly adapt, understand and comply with the new SOE rules, manufacturers have had to submit standard operating procedures (SOPs) to ensure that their operations and their facilities are able to meet the new requirements.
The updated rules have also presented the industry with certain challenges — including delays when importing organic products — resulting in material and ingredient shortages, longer lead times and increased resource costs.
The impact is not just being felt in the US, but also globally as the industry implements the necessary changes to adhere to the new SOE criteria.
International brands manufacturing and distributing products in the US market need to know how these new rules specifically apply to their business and plan accordingly to ensure compliance.
Amazon dietary supplements policy update
One of the biggest policy revisions to impact the industry in 2024 was Amazon’s update to its requirements for dietary supplements sellers on its US platform.
As of 2 April 2024, dietary supplement products must be verified annually by an Amazon-approved third-party testing, inspection and certification (TIC) organisation.
The three companies currently authorised by Amazon to ensure compliance with its Dietary Supplements Policy are Eurofins, NSF International and UL.
Among the key components that will be verified by the TICs for Amazon’s compliance include
- ensuring that products are manufactured at a facility that’s compliant with US FDA good manufacturing practice (GMP) regulations
- checking that products do not contain certain specified contaminants
- the verification of label claims and ingredients
- confirming that products classified as sexual enhancement, weight management or sports nutrition/bodybuilding do not contain undeclared active pharmaceutical ingredients (APIs).
With these policy updates, Amazon has increased its rigour regarding the products that are being sold on the platform; it aims to enhance both safety and quality assurance by requesting testing data and certificates of analysis from an authorised TIC lab for sellers to remain on the platform.
Brands will need to requalify annually within a designated timeframe. When a brand chooses an Amazon-approved TIC, they will work directly with their designated lab to submit the required documentation and samples for product testing/certification to ensure that the brand’s product meets the appropriate criteria.
The TIC lab will then communicate the brand’s approval and certification directly to Amazon to enable the product to remain on sale on the platform. Additional details about Amazon’s policy and each lab’s specific compliance process can be found on the respective websites of the authorised TIC organisations.
Dietary supplement brands should be aware that adherence to these new Amazon policies requires additional costs to implement the verification process.
It’s also possible that the TIC labs will use different testing methods compared with the brand owner’s own facility.
Companies need to be prepared that there could be some back-and-forth communication and added steps as they initially work with their TIC lab to gain approval or take any necessary corrective actions for certification to avoid Amazon delisting.
Dietary supplement brands might consider getting their products certified with a designated TIC lab on an ongoing basis. This would help to reduce any potential for disruption when they reach their product’s annual requirement for renewal.
Essentially, they will already be meeting the requirements by utilising the approved TIC. Brands can also highlight this certification on their labels and in marketing materials to reinforce quality assurance with their end consumers.
Stay educated and informed
Although these policy and regulatory updates have initially presented new challenges for brands, we see these as great steps forward for the dietary supplement industry to help ensure client safety and consumer satisfaction.
As new policies continue to develop and evolve from US federal regulatory agencies — and through Amazon and other large retail distribution channels such as eBay and Walmart — it is important for international brands to have strong US partners that can help them to remain well-informed about critical industry policies and regulations.
These partners include experienced product development contract manufacturing organisations (CMOs).
For larger brands who may have the resources, particularly as the industry continues to require higher levels of quality and places more responsibility directly on the dietary supplements brands, they should also consider having a quality and regulatory compliance staff person or department in-house.
Brands might also consider outsourcing these functions; there are several reputable consultants who specialise in providing regulatory and compliance services and can act as a brand representative to support their compliance needs.
US industry trade organisations can also be a tremendous resource to help brands stay educated and informed about key regulatory/policy updates and other important issues impacting the dietary supplements space.
Among the key US organisations are the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA).
These groups liaise directly with large retailers regarding policies to ensure that the industry is building a safer community of supplement sellers and products in the market. They also work to ensure that new policies are supportive of businesses within the industry.
Global trade shows are another great way for international brands to learn more about the industry, the supply chain and innovative product development and technology trends.
They also provide an excellent opportunity to meet face-to-face with potential partners who can provide services to support them when manufacturing and distributing their products in the US market.
There’s no shortage of resources available for global brands to gain greater industry knowledge, guidance and be better positioned for success in the growing US marketplace, all while ensuring product quality and safety for the end consumer.
References
- www.statista.com/statistics/828481/total-dietary-supplements-market-size-in-the-us/.
- www.ams.usda.gov/rules-regulations/strengthening-organic-enforcement.
- www.ams.usda.gov/services/organic-certification/international-trade/Electronic-Organic-Import-Certificates.