FDA IS CONCERNED ABOUT QUALITY CONTROL
AND SO SHOULD YOU BE...
Each year it is possible to see the trends in FDA inspections and concerns. This practice note looks at some of the typical letters that show us what those concerns have been in recent months.
There are four main areas that I've noted:
[1] Citing medical journal "disease claim" articles to support claims is not allowed.
"When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use."
[2] Failure to establish a system of process and production controls must be addressed.
"...a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record..."
[3] Making medical claims for DSHEA products is never allowed.
"...regular consumption ... may help stave off disease…." / "...reduced inflammation..."
[4] Quality Control / QC Manager issues are primary.
"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement..."
Here are some more detailed excerpts from the Warning Letters reviewed that show you in detail how FDA approaches these issues, followed by my recommendations.
[A] Vita Purity
(i) Disease Claim Citations
"Your website also includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease...
(ii) Production and Process Controls
...You failed to establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). Specifically, you had no written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103, and no written procedures for approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).
You receive finished, packaged and labeled dietary supplements from a manufacturer that manufactures the dietary supplements on your behalf (your contract manufacturer). You hold and distribute the dietary supplements. You state that you specify the active ingredients and their proportions for each of your products. You design and approve the product labels and have them printed and shipped to your contract manufacturer. You sometimes procure dietary ingredients and supply them to your contract manufacturer. You state that you assume your contract manufacturer is responsible for preparing a master manufacturing record, exercising quality control functions, and verifying that the finished products meet specifications. You state that you assume your contract manufacturer is complying with 21 CFR Part 111 because you are unaware of any problems at the plant. You state that you do not have a written agreement with your contract manufacturer, and have not performed any audit or engaged in any other activity to determine the acceptability of the manufacturer to manufacture your dietary supplement products, or to ensure the quality of the dietary supplements received and that the products are packaged and labeled as specified in the master manufacturing record.
As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. [1] In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2))."
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm559804.htm
[B] Maine Natural Health
(i) Disallowed claims
“Vitamin D [an ingredient in the product] may improve heart health…. heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient.”
“Benefits of fish oil [an ingredient in the product] include: reduced inflammation”
“[T]he omega-3 fatty acids in fish oil [an ingredient in the product]…have shown beneficial results for a variety of health problems….like high blood pressure and arthritis. This means regular consumption of fish oil may help stave off disease….”
(ii) Master Manufacturing Record Required
"You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection we noted that you are not preparing master manufacturing records that are unique to the batch sizes being manufactured for each of your dietary supplements. For example, our review of your records indicated that on May 5, 2016, you manufactured one batch of Vanilla Recovery Whey Protein using (b)(4) with a final batch size of (b)(4) and on July 5, 2016, you manufactured another batch of the same product using (b)(4) with a final batch size of (b)(4) following the same master manufacturing record for each batch.
Additionally, in preparing your master manufacturing records for all dietary supplements you manufacture, you must ensure that they meet the requirements of 21 CFR 111.210. For example, the current master manufacturing record for [redacted] Whey Protein does not include the strength, concentration, weight, or measure of each dietary ingredient for each batch size, as required by 21 CFR 111.210(a)."
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590003.htm
[C] Brain Alert
(i) Ultimate Responsibility for Your Own Labels
"Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements [see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)]. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations. "
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589575.htm
[D] Dynamic Technical Formulations
(i) Quality Control Personnel
"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement [see 21 CFR 111.105(a)]. Additionally, the personnel you identified to perform quality control operations do not have the education, training, or experience to perform quality control functions, as required by 21 CFR 111.12(c). Specifically, you identified yourself to our investigator as the quality manager, but admitted that you were not familiar with the Dietary Supplement GMPs and had not received any training to perform the duties associated with quality control.
To fulfill the requirements for quality control operations, your firm must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65."
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589584.htm
BOTTOM LINE -- RECOMMENDATIONS FOR ACTION
We can see from these warnings that the industry is being held to ever higher standards of conduct, as FDA seeks to impose strict Quality Controls. The position of Quality Control Manager is very important. FDA prefers that the QCM is not the Chief Operating Officer, the COO, but reports to, and has immediate access to, the COO and CEO. Each company needs to appoint and train a QCM (and be able to substantiate that training).
My quarter-hour Quality Control webinar (with eBook) covers the duties and qualifications of your QCM. If you want to see my 26 slide presentation, please let me know. I'd be happy to send you the link to the eBook, which has just been posted with the Webinar. If you have access to my Webinar System you can find it there. If not, why not? http://www.vitaminconsultancy.com/webinars.php
These newsletters are archived here: http://vitaminlawyerarchives.blogspot.com/
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