Is Vital Proteins FDA Approved? A Closer Look at Supplement Regulation

A common misconception is that all health products are FDA approved; however, the U.S. Food and Drug Administration does not approve dietary supplements like Vital Proteins for safety or effectiveness before they are sold.

Quick Summary

This article explains the FDA's regulatory framework for dietary supplements, detailing why Vital Proteins is not FDA-approved and outlining the manufacturer's responsibility for product safety.

Key Points

• FDA Does Not Approve Supplements: As a dietary supplement, Vital Proteins is not and cannot be FDA approved for safety or effectiveness before it is marketed.

• Manufacturer is Responsible for Safety: Under federal law, the manufacturer (Vital Proteins) is responsible for ensuring its products are safe and accurately labeled.

• Third-Party Certification Provides Assurance: Voluntary third-party certifications, such as Vital Proteins' B Corp status, and independent lab testing verify the company's standards for quality, sourcing, and purity.

• Past Recalls Have Occurred: Vital Proteins issued a voluntary recall in 2023 for potential foreign material contamination, demonstrating the importance of monitoring manufacturer actions.

• Look for Disclaimers on All Labels: All Vital Proteins products, like other dietary supplements, must include an FDA-required disclaimer stating the product is not intended to treat, cure, or prevent any disease.

• Heavy Metal Warnings Exist: Due to trace chemicals, some Vital Proteins products carry a Proposition 65 warning in California, though third-party testing often finds low levels of contaminants.

The FDA's Role in Regulating Dietary Supplements

In the United States, dietary supplements are regulated differently than prescription drugs. Unlike drugs, which require pre-market approval, supplements are primarily regulated post-market. Manufacturers are responsible for ensuring their products are safe and claims are truthful. The FDA can take action against unsafe products after they are on the market. This framework was established by the Dietary Supplement Health and Education Act (DSHEA) of 1994.

Key aspects of this framework include:

• Manufacturer Responsibility: Companies ensure product quality and legal compliance.
• Labeling Requirements: Accurate ingredient lists and a Supplement Facts panel are required.
• Adverse Event Monitoring: Manufacturers report serious adverse events.
• Facility Inspections: The FDA inspects facilities for compliance with good manufacturing practices (GMP).

Vital Proteins and the FDA: What the Label Means

As a dietary supplement, Vital Proteins is not FDA approved. Its packaging includes a legal disclaimer required for 'structure/function' claims. This allows claims like "supports healthy hair, skin, and nails" if truthful.

The Role of Third-Party Testing and Certifications

Third-party testing and certifications provide consumers with additional assurance of quality and safety since supplements don't receive pre-market FDA approval.

Third-Party Verifications for Vital Proteins

• B Corp Certification: Vital Proteins achieved B Corp certification in 2022, meeting high standards for social and environmental performance.
• Independent Lab Testing: The company uses independent labs to test product lots for heavy metals and microbiological components. Independent reviews, such as Garage Gym Reviews, have also rated Vital Proteins products highly for purity and label accuracy.

Past Issues: Recalls and Heavy Metal Lawsuits

Despite positive testing, Vital Proteins has faced challenges. In 2023, a voluntary Class II recall involved nearly 60,000 canisters due to potential contamination from broken plastic lid pieces. Some products also carry a California Proposition 65 warning due to trace amounts of chemicals, including lead. While the company states these levels are safe, this has led to lawsuits, though third-party tests often show low contaminant levels.

Comparing FDA Oversight to Third-Party Certification

Feature	FDA Regulation (Dietary Supplements)	Third-Party Certification (e.g., B Corp, Independent Lab)
Mandatory?	No pre-market approval; post-market enforcement is mandatory	Voluntary process
Focus	Safety, labeling, GMP, and claims	Quality, purity, specific social/environmental standards
Enforcement	FDA can issue recalls or remove products	Certifying body can revoke certification
Consumer Value	Assures baseline safety post-release	Provides extra confidence through independent verification

Conclusion: Making an Informed Choice

Vital Proteins is not FDA approved as it is a dietary supplement, a category not subject to FDA pre-approval. Manufacturers, like Vital Proteins, are responsible for product safety and labeling. Consumers can look to third-party testing and certifications, which Vital Proteins utilizes, as indicators of quality. It is always recommended to consult a healthcare professional before starting new supplements. More information on FDA supplement regulation is available through their official guidance.

Making an Informed Choice about Supplements

To make informed decisions about supplements:

1. Read Labels Carefully: Check the Supplement Facts panel and disclaimers.
2. Verify Third-Party Testing: Look for certifications confirming purity and quality.
3. Research the Manufacturer: Investigate their history, including any recalls.
4. Consult a Professional: Speak to a healthcare provider, especially with existing health conditions or other medications.
5. Report Adverse Events: Inform the FDA of any negative side effects.

Following these steps helps navigate the supplement market confidently.

Frequently Asked Questions

Does the FDA regulate Vital Proteins at all?

Yes, the FDA regulates dietary supplements like Vital Proteins, but primarily through post-market enforcement. This means the FDA can take action against a product if it finds it to be unsafe, adulterated, or misbranded after it is already on the market.

Why does my Vital Proteins label have an FDA disclaimer?

The disclaimer is legally required on all dietary supplement labels when the manufacturer makes a structure/function claim about the product.

What does third-party testing mean for Vital Proteins?

Third-party testing means that independent, certified laboratories test Vital Proteins products for things like heavy metals and microbiological components. This provides an additional layer of verification for quality and purity beyond the manufacturer's own claims.

Was there a Vital Proteins recall?

Yes, in 2023, Vital Proteins voluntarily recalled nearly 60,000 canisters of its Collagen Peptides due to potential foreign material contamination, specifically pieces of a broken plastic lid. This was a Class II recall, indicating a low risk of serious health consequences.

Why does Vital Proteins have a Proposition 65 warning?

A Proposition 65 warning is required for products sold in California that contain trace amounts of certain chemicals known to cause cancer or reproductive harm. Vital Proteins products may contain trace levels of chemicals like lead, which is why the warning is included.

What is the difference between FDA-approved drugs and dietary supplements?

The main difference is the level of pre-market regulation. Drugs must be proven safe and effective to the FDA before being sold, while dietary supplements are not pre-approved. Supplement manufacturers are responsible for their product's safety and truthful labeling.

Is Vital Proteins B Corp Certified?

Yes, Vital Proteins became a Certified B Corporation in 2022. This certification indicates that the company has met high standards for social and environmental performance, transparency, and accountability, as assessed by the non-profit B Lab.