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How to Ensure Regulatory Compliance When Working with a Supplement Contract Manufacturer

Last updated: April-11,2023

Navigating Compliance Responsibilities When Working with a Contract Supplement Manufacturer

Contract manufacturers are the backbone of the global dietary supplement industry and have allowed supplement brand owners to navigate and meet customer expectations even during the pandemic’s peak. So, if you are a new brand trying to enter the dietary supplement market or an existing supplement brand seeking to expand your product line, you should leverage the partnership with a seasoned, reputable contract manufacturer to benefit from their industry experience, market insights, and expertise.[I]

Additionally, full-service contract manufacturers can also help you bridge the gap between ideation and production, helping you from product formulation, raw material sourcing, and manufacturing support to label design, packaging, and fulfillment. The dietary supplement contract manufacturing industry is experiencing rapid growth, with the global market expected to increase from $7.383 billion in 2021 to $11.466 billion in 2028, with a Compound Annual Growth Rate of 7.61%.[I][ii]

However, despite the increased reliance and demand for contract supplement manufacturing services, it is the responsibility of the supplement brand owner to ensure regulatory compliance regarding the formulation, product quality, labeling, branding, and other federal regulations. And if you fail to comply with FDA supplement regulations, the FDA can issue a Notice of Noncompliance and assess civil financial penalties or legal consequences if you fail to take adequate corrective action within 30 days.[iii][iv] Therefore, as a supplement brand owner, you must navigate the compliance responsibilities even when working with a reputable contract manufacturer.

Understanding Regulatory Requirements

The Food and Drug Administration (FDA) does not approve dietary supplements before they hit the market but plays a significant role in regulating them. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplement brand owners are responsible for ensuring their products comply with the safety standards and other elements of the law. The supplement labels must declare the nutritional information, including recommended serving size, number of servings in the packaging, list of ingredients, and amount of each ingredient per serving. The label must also identify the product as a "dietary supplement" on the front of the packaging. Additionally, supplement brand owners are also prohibited from misbranding the supplement products or making unsubstantiated health claims.[iii][iv][v]

The FDA’s regulatory role starts once the supplement product enters the market. This includes periodically inspecting the manufacturing facilities to ensure Current Good Manufacturing Practice cGMP regulations are followed and reviewing the product label and other information to ensure it does not contain any unsubstantiated health claims that may render them in the category of drugs. Additionally, the FDA also monitors any adverse reports submitted by consumers, healthcare professionals, or supplement companies to ensure the safety of the supplement.[iii][iv][vi]

And if the FDA and FTC find the product to be unsafe, inappropriately labeled, or making unsubstantiated health claims, they have the authority to work with the supplement brand to ensure regulatory compliance, ask the brand to voluntarily recall the product, or take necessary action to remove the product from the market.[iii][v]

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Choosing a Reputable Contract Supplement Manufacturer

Since supplement brand owners bear the responsibility for navigating regulatory compliance, they must choose a reputable and experienced contract supplement manufacturer that can help them understand and adhere to the FDA and FTC regulations. And with a reputable contract manufacturer, you are also assured access to the latest industry best practices as the manufacturer stays informed about any changes in the regulatory requirements and changes in technology that may affect the manufacturing process.[vii]

There are three things you can look at when choosing a contract supplement manufacturer:[vii]

Credentials and Quality Certifications

Looking at the credentials and quality certifications of the contract manufacturers can give you an idea about the quality of the product they produce and their compliance record. Look for things like cGMP certifications before choosing the contract manufacturer.

Capacity and Global Supply Chain

Look at their global supply chain network and manufacturing capacity to ensure they can meet your demand and deliver supplement products to your customers on time.

Experience and Transparency

More experienced contract manufacturers are likely to encourage transparency throughout the manufacturing process, allowing you to oversee the operations and ensure adherence to quality standards and regulatory requirements. See our blog article “7 Questions Your Contract Supplement Manufacturer Doesn’t Want You to Ask” for more information about this.

Oversight and Communication

Collaboration and transparency are at the core of a successful contract manufacturing relationship, and consistent communication and ongoing oversight are a great way to ensure everyone is on the same page and is satisfied with the progress. Even during the pandemic, contract manufacturers realized that not just communication but over-communication was the key to continued operations and a collaborative business environment. This still holds in the post-pandemic world, where information comes from multiple sources, and brand owners must collaborate effectively with contract manufacturers to respond to changing market trends and consumer demands.[viii]

Some of the things that can help brand owners communicate effectively with the contract manufacturers and keep oversight of the manufacturing process include:

  • Maintain clear documentation of expectations, obligations, and duties of both parties.
  • Set up regular (e.g., weekly) update calls to stay in the loop.
  • Be direct and transparent about any expectations and potential challenges to facilitate collaboration.

With clearly set expectations and clear communication, supplement brand owners can leverage the experience and expertise of reputed contract manufacturers, navigate the regulatory responsibilities, and expand their product range with the supplements their consumers want.

How Can NutraScience Labs Help?

Since the responsibility to navigate regulatory compliance falls on supplement brand owners, it is essential for them to choose the right contract manufacturer, have a detailed contract in place, and ensure ongoing oversight to ensure they are not in violation of FDA or FTC regulations.

With more than 120 years of combined nutraceutical industry experience, NutraScience Labs has an impeccable reputation for being the go-to contract manufacturer for supplement brands seeking to formulate and manufacture high-quality dietary supplement formulas. In addition to our award-winning contract manufacturing services, our full-service packaging & label design and fulfillment services have saved more than 2,300 supplement businesses countless amounts of time, money, and stress.

If you are thinking about capitalizing on the growing demand for supplements, then contact our team today! Call 855-492-7388 to speak with one of our knowledgeable representatives, or send us your request to receive a competitive supplement manufacturing price quote free of charge.


[i] https://www.naturalproductsinsider.com/contract-manufacturing/full-service-contract-manufacturing-advantage

[ii] https://www.businessresearchinsights.com/market-reports/dietary-supplement-contract-manufacturing-market-102792

[iii] https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements

[iv] https://www.fda.gov/food/dietary-supplements

[v] https://www.ftc.gov/news-events/news/speeches/ftc-dietary-supplements

[vi] https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps

[vii] https://www.akums.in/3-tips-to-help-you-choose-a-nutraceutical-contract-manufacturer/

[viii] https://www.nutritionaloutlook.com/view/contract-manufacturing-for-dietary-supplements-lessons-from-the-covid-19-pandemic

April 10th, 2023

About the Author:

Andrew Goldman

Andrew Goldman is the Vice President of Marketing for NutraScience Labs. In this role, he leverages his 15+ years of B2B inbound marketing experience to develop cutting edge strategies for our firm. A health and fitness enthusiast, Andrew and his team won the 2012 Stevie Award for Marketing Team of the Year. He is also a two-time Best In Biz Silver Award winner for Marketing Executive of the Year and has received other honors and accolades for his website design work.