Avoiding Pitfalls in Starting a Supplement Company
Table of Contents:
- Introduction
- Misconceptions about Contract Manufacturers
- Sprinkling of Ingredients
- Low Ingredient Amounts
- Conflict of Interest
- Skewed Contracts with Manufacturers
- Ensuring Compliance with FDA GMP Requirements
- Avoiding Pitfalls and Launching Your Brand
- Signature Dietary Supplement Sessions
- Supplement Startup Essential Training (SET)
- Directory of Contract Manufacturers
- Understanding Best Before Dates and Expiration Dates
- Requirements for Shelf Life Testing
- Navigating Operational Matters for Your Brand
- Conclusion
- Additional Resources
Misconceptions About Contract Manufacturers
Contract manufacturing in the dietary supplement industry is often misunderstood. Many people assume that a contract manufacturer will formulate and produce a product that is effective and lives up to its claims. However, this isn't always the case. In reality, some manufacturers only include a small amount of trendy or scientifically studied ingredients, making the product technically present but not effective.
One example is the use of ashwagandha extract in dietary supplements. While a stress relief clinical trial used 240 milligrams of ashwagandha extract, some products on the market contain only 62.5 milligrams per serving. Contract manufacturers often keep ingredient amounts low to reduce costs and entice brands to commit to orders. However, this can lead to legal issues with bodies like the FTC or FDA, as well as potential lawsuits from dissatisfied customers.
It's crucial for brand owners to be actively involved in formulating their products and ensure that they are genuinely effective. Partnering with manufacturers who have no conflict of interest in limiting ingredient amounts is essential for minimizing risks.
Skewed Contracts With Manufacturers
When entering into a contract with a manufacturer, it's vital to carefully review the terms and conditions. Many standard contracts appear promising initially, boasting certifications and third-party audits. However, these contracts often fail to include crucial clauses that hold the manufacturer responsible for complying with FDA Good Manufacturing Practices (GMP) requirements.
Usually, these contracts place the burden of ensuring compliance on the brand owner, even though they are not directly involved in manufacturing the product. To protect both parties' interests, it is necessary to negotiate adjustments to the contract to create a fair and reasonable agreement that ensures compliance and quality of the products.
Avoiding Pitfalls and Launching Your Brand
If you're considering launching your own supplement brand while avoiding the potential pitfalls mentioned, there are two options to consider. First, you can book a signature dietary supplement session directly with an industry insider who specializes in regulatory affairs and quality assurance. This session will provide insightful guidance tailored to your specific brand and goals.
Secondly, an alternative option is the recently introduced Supplement Startup Essential Training (SET). This comprehensive training covers a wide range of topics and questions curated from past client sessions and the trainer's industry experience. SET allows for more in-depth discussions, surpassing what can typically be achieved in a consultation session.
Included in SET is a directory of contract manufacturers, saving you precious time during the supplier selection process. Additionally, the training may include exclusive promotional offers, which can further assist in launching your brand effectively and efficiently.
Understanding Best Before Dates and Expiration Dates
When working with a contract manufacturer, you may be asked to choose between a best before date and an expiration date for your products. It's essential to understand the implications of this decision. The FDA mandates that brands should have data supporting the chosen shelf life, requiring stability testing, which can take several months and cost thousands of dollars per product.
For new brands, manufacturers often neglect to inform them about these requirements, leading to potential legal and financial issues. It is crucial to be aware of all operational matters for your brand, including shelf life testing, in order to navigate FDA and other regulatory requirements successfully.
Conclusion
Launching a dietary supplement brand entails various challenges, from navigating FDA regulations to ensuring product effectiveness and quality. Misconceptions about contract manufacturers, skewed contracts, and compliance with regulatory requirements are common pitfalls that aspiring brand owners should address.
By staying informed, seeking professional guidance, and utilizing resources such as dietary supplement sessions and SET training, you can avoid many of these pitfalls and set your brand up for success in the competitive dietary supplement industry.
Additional Resources
To further assist you in your journey, check out the additional resources linked below:
- Supplement Startup Essential Training (SET)
- Directory of Contract Manufacturers (included in SET)
- Video: Understanding Operational Matters for Your Supplement Brand
- Video: Navigating FDA and Regulatory Requirements
FAQs:
Q: Are all contract manufacturers the same?
A: No, contract manufacturers vary in terms of certifications, quality assurance practices, and compliance with regulatory requirements. It's crucial to research and select a reputable and trustworthy partner.
Q: What is the difference between a best before date and an expiration date?
A: A best before date indicates the period during which a product is at its best quality but can still be consumed after the date. An expiration date signifies the last date a product can be consumed safely. The choice depends on the product and regulatory requirements.
Q: Is stability testing mandatory for all dietary supplements?
A: Stability testing is necessary to support the chosen shelf life of a product. However, smaller brands may not be aware of this requirement or the associated costs. It's essential to have a clear understanding of the testing process and its implications for your brand.
