New Tariffs: Why International Regulatory Affairs Experts Matter
When a leading supplement brand saw costs spike 15% overnight due to new tariffs, its entire supply chain stalled. Production schedules slipped while pricing agreements with retailers became untenable. Without international regulatory expertise, the company faced a crisis.
A 10% universal tariff now applies to imports from non-exempt countries, with reciprocal tariffs ranging from 11% to 50% scheduled to take effect. A 90-day pause has been implemented for most countries excluding China. The White House has exempted key supplement ingredients—vitamins, amino acids, minerals and CoQ10—from new tariffs source.
For supplement manufacturers, this means navigating a complex web of regulations while managing costs. Companies without dedicated international regulatory affairs experts now face significant compliance risks and missed optimization opportunities. Crescent Edge Consulting places top international regulatory affairs experts in supplement companies.
Why International Regulatory Affairs Experts Matter for Supplement Companies
The regulatory environment for supplements has become increasingly complex. According to recent data, the U.S. dietary supplement market exceeds $60 billion annually with over 100,000 products available. This growth has triggered intensified FDA scrutiny.
Dietary supplement companies must also comply with Current Good Manufacturing Practices (cGMPs) to verify ingredient identity, strength, purity and composition source.
Non-compliance costs are steep. Under the False Claims Act, companies found liable for tariff violations can face penalties up to $28,619 per false claim, plus three times the amount of underpaid tariffs.
But regulatory experts do more than prevent fines. They transform compliance challenges into competitive advantages by identifying exemptions and optimization strategies that competitors might miss.
Understanding the New Tariffs Impacting the Supplement Industry
The White House recently released a revised list of goods exempted from Global and Reciprocal Tariffs, which includes vitamins, amino acids, minerals, and CoQ10. The USTR confirmed a dietary ingredient tariff exemption for specific botanicals and amino acids source. The Natural Products Association is urging expansion of exemptions to cover all essential vitamins, minerals and amino acids source.
However, many ingredients remain subject to tariffs. Industry experts warn that the 10% tariff against goods from China may lead to price increases and spur inflation across the supplement sector.
The Role of International Regulatory Affairs Experts
Regulatory affairs experts navigate the complex web of international trade regulations. Their responsibilities include:
Accurate customs classification of ingredients and finished products
Interpretation of country-specific labeling requirements
Monitoring changing tariff schedules across multiple markets
Coordinating with legal, quality assurance, and supply chain teams
Ensuring Regulatory Compliance and Avoiding Penalties
Regulatory experts implement systematic audit processes to ensure ongoing compliance. They maintain comprehensive documentation and identify potential issues before they trigger penalties.
The FDA conducted approximately 600 inspections across 90 international facilities in FY24, covering only about 5% of known dietary supplement facilities. This limited coverage creates a false sense of security for many companies. Expert guidance helps prepare for these high-stakes inspections that, though infrequent, can result in significant penalties when compliance issues are found.
Strategic Cost Management and Duty Optimization
Smart tariff strategies can offset increased costs. These include:
Tariff engineering: Modifying products or processes to qualify for lower duty rates
Leveraging Free Trade Agreements to secure preferential treatment
Establishing operations in Foreign Trade Zones to defer, reduce, or eliminate import tariffs
Duty drawback programs can recoup paid tariffs when products are re-exported source
Companies can adopt three key strategies for tariff optimization: reshoring production, regionalizing supply chains, or finding alternative suppliers to mitigate tariff impacts. Companies leveraged USMCA to secure duty-free treatment on certain intermediates source.
Benefits of Engaging International Regulatory Affairs Experts
The benefits of working with regulatory experts extend beyond compliance:
Reduced risk of shipment delays, product seizures, and market withdrawals
Faster market entry through streamlined approval processes
Enhanced brand reputation through demonstrated compliance excellence
Access to a growing global Regulatory Affairs market (USD 15.30 billion in 2023, projected to USD 30.16 billion by 2030) source
Key Criteria for Selecting the Right Regulatory Affairs Partner
When selecting a regulatory affairs expert, look for:
Recognized credentials such as the Regulatory Affairs Certification (RAC) or Global Regulatory Affairs Compliance Professional (GRACP) designation
Specific experience in the supplement industry
Track record of successful tariff optimization
For supplement companies, experts with the Advanced Certification in Dietary Supplement Regulatory Affairs (ACDSRA) bring specialized knowledge to navigate industry-specific challenges.
Case Study: Navigating New Tariffs with Expert Support
This hypothetical example illustrates how regulatory expertise can make a difference:
A mid-sized supplement company faced a 15% tariff increase on key ingredients sourced from Asia. Their regulatory affairs expert implemented several strategies:
Reclassified several ingredients to qualify for exemptions
Restructured documentation to clearly demonstrate compliance
Identified alternative suppliers in countries with preferential trade status
Take Action Now: Engage Regulatory Affairs Experts to Navigate New Tariffs
The new tariff landscape makes international regulatory affairs expertise not just valuable but essential for supplement companies. These professionals help navigate complex regulations, optimize costs, and maintain compliance.
Companies that invest in regulatory expertise gain a significant competitive advantage through cost savings, risk reduction, and smoother global operations.
Now is the time to review your regulatory strategy. Contact Crescent Edge Consulting to secure the regulatory affairs talent that will keep your supplement business compliant and competitive.
