The U.S. aesthetic industry, particularly the market for botulinum toxins and dermal fillers, is facing an emerging threat: international tariffs. The federal government’s ongoing trade tensions and the possibility of new tariffs on aesthetic injectables could have serious consequences for providers, manufacturers, and patients alike.
As a Medical Spa owner, you’re constantly navigating a web of clinical, regulatory, and operational concerns. Now, there’s a growing risk that could heavily disrupt your supply chain, raise your costs, and expose you to new legal liabilities. Here’s what you need to know to protect your practice.
What’s Going On With Tariffs?
The U.S. government is reviewing and potentially reinstating tariffs on a range of imported goods, including aesthetic medical products, under Section 301 of the Trade Act. While initial attention focused on China, tariffs also apply to injectables and related goods imported from several major countries, including China, South Korea, Germany, Switzerland, France, Ireland, Italy, and Mexico.
In 2022, the U.S. imported over $215 million worth of injectable aesthetic products and components from these countries. If even a portion of these products become subject to tariffs, the price increases could ripple through the entire medspa industry.
This is not just about finished products. These tariffs may affect the cost and availability of Botulinum toxins,dermal fillers, and critical accessories like injectable syringes and needles, cannulas, packaging components, active pharmaceutical ingredients (APIs), and manufacturing chemicals.
The Global Supply Chain Behind Your Injectables
Although injectables are administered in treatment rooms, many are manufactured, or have components manufactured, abroad. For example:
- Botulinum Toxins: Products like Botox, Dysport, and Xeomin are produced in various countries. Botox is primarily manufactured in the U.S. and Ireland, Dysport in the U.K., and Xeomin in Germany. However, some key ingredients or components may still originate in Asia.
- Dermal Fillers: Brands like Juvederm are produced in France, while Restylane comes from Sweden. Sourcing of packaging, syringe components, and raw materials often ties back to Chinese suppliers.
- Medical Devices & Syringes: A significant portion of the packaging and injection delivery systems are made in China—even when the drug product itself is not.
According to trade data, China accounted for $35.5 million in injectable-related exports to the U.S. in 2022 alone, covering everything from finished goods to essential components.
What the Tariffs Could Do
The U.S. government is considering tariffs on certain medical and aesthetic products imported from other countries. While these tariffs are intended to increase pressure on manufacturing in broader trade negotiations, the aesthetic industry could become collateral damage.
If the tariffs are reinstated or expanded to include injectables and related products, Medical Spas may experience:
- Increased cost of goods sold: Product prices could rise significantly, forcing practices to choose between absorbing the costs or passing them on to patients.
- Delays in product availability: Shifting global supply chains may cause shortages, especially for fillers and accessories like cannulas and syringes.
- Increased legal risk: Cost may push some providers toward unauthorized distributors or off-label products, exposing themselves to regulatory penalties and malpractice liability.
In 2023, the U.S. botulinum toxin market was valued at over $2.6 billion, with the dermal filler market adding another $1.9 billion. China supplied roughly $9.7 million worth of injection-related packaging, $17.6 million in raw materials and bulk components, and over $8 million in finished syringes and aesthetic device parts in 2022. These numbers represent just a small percentage of the total injectable ecosystem and reflect how interconnected U.S. providers are with global production.
Legal Implications for Medspas
From a legal and compliance standpoint, this is where things can go wrong fast. If tariffs trigger product shortages or price hikes, the risks include:
- Use of diverted or counterfeit products: These are often sold online or through unverified wholesalers. Even if a product looks legitimate, using it can lead to regulatory violations and patient harm.
- Gaps in informed consent: If you switch injectable brands, use an alternative product, or experience inconsistent results due to supply substitutions, your consent process must reflect those changes.
- Improper sourcing documentation: You must maintain clear records proving that every product used was obtained through a licensed and FDA-compliant channel. In times of market disruption, inspectors and insurers often scrutinize these records more closely.
How to Protect Your Practice
As the legal landscape shifts, preparation is your best defense. Here are our recommendations:
- Audit your supply chain: Know exactly where your injectables and medical devices are coming from and confirm they’re sourced through approved vendors.
- Strengthen consent protocols: Ensure your patient documentation reflects any substitutions, brand differences, or known side effect variations.
- Train your team: Educate staff on the legal risks of unauthorized sourcing, and establish a “no exceptions” policy for procurement.
- Monitor regulatory updates: Follow updates from the U.S. Trade Representative (USTR), your product manufacturers, and your legal advisors. If tariffs are reinstated, your purchasing decisions may need to change quickly.
Looking Ahead
While the aesthetic industry is actively lobbying for tariff exemptions, arguing that these products have medical uses and a well-regulated track record, there’s no guarantee that relief will come. As a Medical Spa owner, you don’t need to become a trade lawyer, but you do need to understand how global policy can impact your day-to-day operations and your legal responsibilities.
If you need help reviewing your sourcing contracts, updating your compliance protocols, or navigating potential liability tied to product availability, our team at Lengea is here to support you.