mdi ConsultantsOur analysis of recent FDA warning letters issued to the dietary supplements industry signaled the FDA turned its GMP enforcement emphasis to the importers, distributors and private labelers of dietary supplements. However, time and time again, we see that many of our clients mistakenly believe that manufacturers or contract manufacturers of dietary supplements are the only parties responsible for Part 111 compliance. Well, read our update and think again.
This article is an exhaustive summary of numerous warning letters issued to dietary supplement companies and is intended to shed light on the FDA regulations applicable to importers, distributors and private labelers. You may be shocked to find out about all the GMP requirements FDA expects to find in place at the importers, distributors and private labelers operations. For example, would you know that if you outsourced the entire manufacturing, packaging and labeling activities for a dietary supplement to a contractor and the only thing that ties your company to the product is your company’s name on the product label, it is you and not your contract manufacturer who is considered responsible for a large number of GMP compliance items.
Shocking or not, these FDA requirements are not optional but mandatory. You must follow this path or risk having your business impacted as a result of FDA non-compliance. So read on.
Background:
In the number of recent FDA warning letters, FDA clarified their view point on the product owner responsibility for compliance with dietary supplement GMP’s, (21CFR Part 111). Product owner is considered a company whose name appears on the dietary supplement label irrespective if such company is also the actual product manufacturer, importer or distributor. FDA stated they view the product owner as ultimately responsible for required GMP compliance even if the manufacturing activities are outsourced. Specifically, the following explanation is included in every FDA warning letter issued to the dietary supplement distributors:
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements.
Deficiencies included in the Warning Letters:
• Unapproved New Drugs: Marketing the dietary supplements with disease related claims that rendered them as drugs and FDA classification of such products as unapproved new drugs.
• New Dietary Ingredients: Dietary supplements included ingredients that were not previously classified by FDA as dietary ingredients. According to the FDA regulations, a notification for a New Dietary Ingredient must be submitted to FDA prior to marketing. A notification requirement for a new dietary ingredient applies to any dietary supplement that contains a new dietary ingredient that has not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.
• Dietary Supplements cGMP (21CFR Part 111) violations:
This was the major area of concern and FDA found non-compliance in various sections listed below:
- Failure to establish specifications for identity of product components and ingredients
- Failure to establish specifications for identity, strength, purity, composition and limits on types of contamination that may adulterate the finished products
- Absence of written Master Manufacturing Records(MMR) for each unique formulation of dietary supplement and for each batch size
- Failure to establish specifications for packaging and labeling according to purchase order and perform visual inspection of incoming products
- No formally defined responsibilities for Quality Control Department
- Failure to properly investigate complaints and report Serious Adverse Events to FDA within 15 days of becoming aware
- Lack of stability data in support of expiration date or “best by date” if stated on the product labeling
Conclusion:
As you can see from the above observations, FDA has started to screen and inspect the dietary supplement establishments including product distributors with the same intensity as the drug and device manufacturers. Whether you are a manufacturer or distributor or private labeler of dietary supplements, you NEED to take the FDA regulations for dietary supplement GMP’s with full seriousness and implement appropriate systems to assure that your operations are in compliance with the FDA requirements.
Waiting for the FDA to inspect your operations would not be the time to begin implementing your regulatory responsibilities. You must be in compliance already and we recommend that you use the available time as an opportunity to bring your operations in required compliance prior to the FDA visit.
mdi Consultants Inc. have been providing FDA guidance to numerous dietary and nutritional supplements companies for the past 20 years. If you have any doubts or want guidance regarding the FDA compliance matters, please email us at info@mdiconsultants.com and REF: FDA Dietary Supplements and we will help in every best way possible.