FDA Registration – What it is, why it matters: A Q&A with UNPA’s VP of Global Regulatory and Compliance Larisa Pavlick

September 10, 2020

Several companies in our industry have elusive complaints departments, leading one to surmise they pay lip service at best to many quality issues. It seems in fact, that these companies have placed the customer complaint component of their business upstairs without a staircase with staff hiding anytime someone with a complaint inquires.

Consumer safety is a serious thing, and the FDA (Food & Drug Administration) has repeatedly argued and reinforced the need for Adverse Event Reporting and other reporting and registration requirements under current US law and guidance. It is absolutely logical that brand owners are required to provide accurate contact information to consumers and furthermore, Congress has emphasized this accountability through legislation such as the Bioterrorism Act of and the Food Safety Modernization Act.

The Bioterrorism Act of 2003 was one of the most important safety measures provided to the dietary supplement industry since the Dietary Supplement Health Education Act of 1994 was passed almost a decade prior. This Act was adopted by Congress in response to the terrorism threats realized after the 9/11 attacks in 2001. The Food Modernization Act in 2010 strengthened the requirements of the Act and FDA powers. Together, these pieces of legislation provided consumers a format to notify regarding adverse events and allowed industry and agency to monitor adverse events trends to catch signals early.

Unfortunately, many brands within the dietary supplement industry have become creative in avoiding or subverting the requirement to provide clear and effective contact information.

A good friend of Trust Transparency Center, Larisa Pavlick, former FDA investigator, now VP, Global Regulatory and Compliance at United Natural Products Alliance, has provided us some commentary regarding the broad topic of FDA Registration:

  1. Should brands be required to maintain Registration with the FDA?

LP:  Yes, registration is REQUIRED by the Food Drug and Cosmetic Act as amended by the Food Safety Modernization Act (FSMA). Failure to register was one of our first questions as a former FDA investigator when I conducted an inspection. We also would check registration status before we arrived as part of our background work, so we already knew the answer; however, we asked it anyway as a standard question and documented the response.

After the implementation of FSMA, food facilities (including dietary supplement and ingredient suppliers) are required to re-register every two years during the even years. The FDA re-registration period is between October and December. Registration during any other time may complicate the records so I recommend sticking to this schedule. If you fail to register during this time, get it done as soon as possible. 

Failure to register could result in a warning letter even with no other GMP violations. Most investigators, per supervisor feedback, would encourage voluntary compliance with registration and would allow a facility to register prior to the closeout of the inspection. However, failure to register was documented in the establishment inspection report and you can only get this courtesy “pass” once.

Here is a good FDA link:

During vendor qualification, companies should be asking their suppliers for their FDA registration number (Food Establishment Inventory [AKA FEI] number) and then verifying it is accurate and current using the above link or the FDA Data Dashboard.

More information on Food Facility Registration, from an investigator’s perspective, can be found in the FDA Investigations Operations Manual (IOM). The IOM is essentially the “bible” for the FDA investigator. We were required to follow all established procedures inside of this manual re-printed and updated annually.

Here is a link. There is significant information provided on pages 5-53 to 5-54. 

  1. Should international ingredient suppliers register with the FDA?

LP: Yes, it is required. Any product imported to the U.S. is required to meet all applicable laws and regulations. As a U.S. company importing FDA regulated products intended for consumption in the United States, companies are required to be compliant with the FSMA Foreign Supplier Verification Programs (FSVP).  Under this rule, the receiving company is responsible to verify compliance with applicable U.S. regulations which include Good Manufacturing Practices and facility registration. 

I recommend all companies producing consumable goods familiarize themselves with 21 CFR Part 117-Preventive Controls Rule for Human Foods, Subpart G: Supply Chain Programs.  This is the modernized approach to Supply Chain Management. 

  1. Do you have any thoughts or comments regarding the adequacy of information provided as part of the FDA requirement of brands to supply contact information on supplement labels? (Currently, several brands place their Delaware incorporation address as the address of record to the FDA. Also, we are finding numerous labels with incorrect information.)
    LP: Contact information is required by the FD&C under Misbranding (Sec 403)

“A food shall be deemed to be misbranded-….

(y) : If it is a dietary supplement that is marketed in the United States unless the label of such dietary supplement includes a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with the supplement.”

As an investigator, we were looking for information on the label under the supplement facts panel, including: 1) the Company name with the disclosure of “manufactured for” or “distributed by” such as with contract manufactured goods, 2) an address which could be shortened to the city, state if the full address could be located in a listed in a current directory (AKA phone book…who uses those anymore?), 3) and a phone number. 

I had the debate several times with my supervisors saying they could not hold a company to both address and phone number; however, in the Denver District Office, I never won this debate. 

FDA staff shared with me that they believed SAER were reduced due to the inability of the consumer to easily contact the organization. 

Our TTC review of offerings from the Amazon marketplace provides examples of companies not registered in the FDA Database. In speaking with some brand owners (all of which choose to be unidentified) one consistent expressed belief is that by not registering or easy location/information access, the likelihood of FDA inspection is reduced, a thought process in violation of FDA requirements and an irresponsible attitude to take in terms of consumer safety.

It is quite easy to find examples of popular Amazon products where it is nearly impossible to receive a response to a complaint. One example is Divine Bounty out of Orlando, FL. TTC has purchased product from this company that was listed as an “Amazon’s Choice” product and subsequently requested a conversation through both the contact information on the website and visiting the front desk of the company (an executive suite where the receptionist said she has never seen anyone associated with the company). There are others like this.

Key takeaways from this discussion:

  • As a consumer, any company with unclear contact information or refusal to engage should be avoided
  • For any brand, facilities should be registered with the FDA Database: FDA Registration Online
    • Retailers should make this a mandatory aspect of vetting
    • Consumers should make this a requirement for purchase decisions
  • Ease of submitting customer complaints or concerns should be a criteria for determining company compliance in following overall FDA regulatory adherence


Scott Steinford is the Founder of Trust Transparency Center

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