The U.S. Food and Drug Administration (FDA) reports that 20% of supplements on the market contain unapproved and potentially harmful ingredients. This may leave you wondering whether you can truly trust those in charge of overseeing these products.  

Despite this concerning fact, we’re here to assure you that you can. To find out why, listen to Episode 13 of our podcast, featuring Brian Yam, a compliance consultant who provides behind-the-scenes insights into the processes behind product testing.  

He explains how companies ensure their products meet regulatory standards and what happens when they fail to comply. If you’d prefer to read about these product testing insights, check out our blog post, which dives into the details of this episode.  

Understanding Compliance: More Than Just Guidelines  

What does compliance really mean? It refers to strict standards set by the FDA and FTC (Federal Trade Commission) that companies must follow to ensure they are marketing safe and effective products.  

Compliance also demonstrates that a health and beauty company knows exactly what ingredients are in their products and is truthful about them. Unfortunately, some companies do stretch the truth about their offerings.  

For instance, in 2018, Gwyneth Paltrow faced legal action over false claims regarding the health benefits of jade vaginal eggs. Because her company, Goop, marketed health products based on pseudoscience, it was required to pay a $145,000 settlement.  

We’re certain that after this misstep, Paltrow took a closer look at FDA guidelines to prevent a repeat incident. These regulations are in place to ensure products are safe for use and backed by effective research. Brian emphasizes that compliance isn’t just about meeting regulations; it’s about fostering a culture of quality within the company.  

If you’re considering starting your own personal care brand, there are important steps you must take before entering the market. Listen to our guest, Brittany Lo, as she shares valuable insights on launching your own health and wellness brand.  

Addressing Common Misconceptions

One of the biggest misconceptions in the health and wellness industry is that supplements are unregulated. Brian explains that this isn’t entirely true, as the FDA does play a role in regulating dietary supplements. 

However, enforcement can sometimes be inconsistent. Brands that follow FDA regulations help maintain product quality and consumer safety.  

Another misunderstanding in the health and wellness world is that product testing is the sole determinant of safety. Effective compliance involves various procedures, including proper manufacturing practices, adherence to Good Manufacturing Practices (GMP), and thorough documentation.  

There’s a dark side to every industry, including skincare. How can you be sure the skincare product you’re using doesn’t have hidden risks that could harm you? Listen to Ella Cressman to find out.  

Evaluating Product Safety and Compliance: Tips for Consumers  

With so many health claims on the market, how can you make informed decisions about which products to trust? Brian advises consumers to scrutinize product labels and certifications carefully.  

Look for brands that have been around for a long time, as they tend to be more established and committed to compliance practices. Being part of a larger parent company can also indicate higher standards due to access to better resources for quality control.  

For certifications, look for NSF (National Sanitation Foundation) or USP (United States Pharmacopeia). These third-party certifications validate a product’s safety and efficacy.  

Also, be wary of labels making claims such as “boosts the immune system” or “regenerates cartilage.” These could indicate that the company is exaggerating the benefits of its products.  

Substantiating Claims in the Health and Wellness Market  

When it comes to health claims in the wellness industry, always check if the product’s testing involved human clinical trials. Most brands base their claims on preliminary studies conducted on animals or in vitro. 

However, these types of tests do not meet regulatory standards. Human clinical trials provide more robust evidence and help maintain compliance while building consumer trust.  

Funding human clinical trials poses significant challenges, especially for startups. However, basing health claims on credible human studies is crucial to fostering trust and ensuring regulatory compliance.  

Want to learn how to spot trustworthy brands with ease? Donald Kelly shares marketing tactics to help you become a smarter consumer.  

Behind the Lab Door: Handling Out-of-Spec Situations  

What happens when a product has an out-of-specification (OOS) issue? Brian explains that addressing OOS problems requires close collaboration between the lab, manufacturer, and brand owner.  

The severity of the OOS—whether critical or minor—determines the next steps. It could lead to a temporary sales pause while thorough investigations identify the root cause. Addressing OOS issues effectively ensures they don’t happen again in the future.  

Career Pathways into Compliance  

If you’re interested in becoming a compliance consultant like Brian, know that experience often matters more than formal education. Brian shares that his journey into the field was a natural progression from his academic background.  

Starting with internships and co-op programs, he transitioned into regulatory and compliance roles. His hands-on experience paved the way for his career as a compliance consultant. He advises aspiring professionals to seek mentorship opportunities within consulting firms to gain valuable insights and a strong foundation in the field.  

The Unsung Heroes of the Health and Wellness Industry  

Compliance professionals like Brian Yam work tirelessly behind the scenes to ensure products are safe, effective, and marketed truthfully. While their work often goes unnoticed, it plays a vital role in protecting consumers and helping brands thrive sustainably.  

If you’d like to learn more about Brian and his work, visit his consulting website, Blue Ocean Regulatory. For startups looking for entrepreneur tips, check out his YouTube channel, Mighty Startup.