Statement from Highland Laboratories

For over 50 years, Highland Laboratories has been dedicated to producing high-quality dietary supplements that support health and wellness. As a longstanding manufacturer in the dietary supplement space, we take our commitment to consumer safety and regulatory compliance seriously, operating under the FDA's current Good Manufacturing Practices (cGMPs), as set forth in 21 CFR Part 111.

Why We Use Manufacturing Dates Instead of Expiration Dates

In compliance with 21 CFR Part 111, specifically:

• 21 CFR § 111.35(e), which requires manufacturers to establish a scientifically valid testing program to determine appropriate storage conditions and shelf life,
• 21 CFR § 111.60(b), which mandates that the manufacturer ensures each batch meets its specifications through stability testing, and
• 21 CFR § 111.83(b), which requires adequate stability data to support label claims regarding expiration dates,

Highland Laboratories has made a strategic decision to display manufacturing dates on our products rather than expiration dates.

While we have been manufacturing many of our products for over 25 years and possess ample historical data to guarantee that our products remain stable and potent over time, the FDA has stipulated that stability studies must be conducted under rigorous, specific conditions that align with clearly defined protocols. These conditions include testing under multiple environmental variables such as temperature and humidity and necessitate extensive monitoring of product integrity. Conducting these stability studies according to these strict rules can be cost-prohibitive and, in some cases, unwarranted given the nature of our products and historical performance.

We recognize that many dietary supplement brands use expiration dates on their products without conducting the necessary stability studies. Very few supplement companies have completed the comprehensive testing required to support such claims under cGMP regulations. While the practice of displaying expiration dates without adequate stability testing may be common, it does not align with the spirit of FDA regulations or our ethical commitment to transparency and consumer safety.

Our Commitment to Transparency and Compliance

By providing manufacturing dates on our products, Highland Laboratories prioritizes transparency and regulatory integrity. Manufacturing dates indicate when a product was made, allowing consumers to make informed decisions about product freshness. This approach ensures we remain compliant with FDA regulations while maintaining the highest standards of product quality.

We remain committed to the safety, efficacy, and quality of our products and will continue to uphold our responsibility to our consumers by adhering to the most stringent regulations applicable in the dietary supplement industry.

Sincerely,

Highland Laboratories