We live in a world where trusting others is part of everyday life. The professional service industry relies on clients that can’t or won’t perform complex tasks such as plumbing, electrical, vehicle repair, etc. The nutraceutical manufacturing industry isn’t much different when it comes to properly testing and assembling components for dietary supplements. Nutraceutical manufacturing is extremely complex and time-consuming when compliant under the strict Current Good Manufacturing Practices (CGMP) rules mandated by the FDA. We should expect nothing less than ultra pure, high quality and uncontaminated ingredients in every nutraceutical that we consume.
While much of the nutraceutical industry is CGMP compliant, there are numerous manufacturers that are not compliant. The range of non-compliance varies widely. An otherwise legitimate manufacturer might simply have a few technical hiccups that haven’t physically endangered the integrity of the final product to be consumed. On the opposite end of the spectrum, you have manufacturers that produce fraudulent products that masquerade as nutraceuticals which presents a clear and present danger to the public.
Non-Compliance: Case in Point
On April 2, 2012 the FDA sent a warning letter to Theta Brothers Sports Nutrition, Inc. (DBA: Protein Factory®). The FDA noted that inspections done October 11, 2011 through November 8, 2011 yielded numerous CGMP violations including:
- The failure to adequately clean equipment and utensils to protect components and dietary supplements from being contaminated by any source. For example, the investigator found that they manufactured their Egg White Protein product followed by non-egg containing products (WPC/Dextrose Vanilla).
- The failure to verify that the finished batches of dietary supplements meet product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch.
- The failure to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. Specifically, the failure to establish component specifications for each component that were used to manufacture dietary supplements, and the failure to establish product specifications for the identity, purity, strength, and composition of some of the dietary supplement products manufactured at the facility.
- The failure to follow the requirements for batch production records (BPRs).
- The failure to include all the information required in the master manufacturing records (MMRs). The investigator found that ingredients such as flavorings and the vitamin and mineral mix were adjusted by employees during production for each batch size. The investigator found that the employees adjusted amounts of ingredients from memory based upon ratios learned from other employees.
- The failure to establish written procedures for identifying each unique lot within each unique shipment of components.
- The failure to use a unique identifier whenever they recorded the disposition of each unique lot within each unique shipment of components that they received and any lot of components that they produced.
- The failure to make and keep required records related to quality control operations. Specifically, they were unable to produce documentation that quality control personnel performed the review, approval, or rejection related to approving components and releasing them from quarantine.
- The failure to establish written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.
- The failure to use equipment of appropriate design and construction so that use will not result in the contamination of dietary supplements, and failure to maintain equipment to protect components and dietary supplements against contamination from any source. Specifically, they are blending all products in commercial grade and one stock pots (i.e. soup pots), and mixing all powder blends with a handheld electric mixer. The FDA investigator observed that the stock pots were heavily scored, as was the stock pot. The stock pot was purchased during the period in which the FDA conducted their inspection, and therefore became scored after only minor use. In addition, the mixing blade of the handheld mixer was chipped in several areas. As a result of this chipping and scoring, the equipment fails to protect the dietary supplement products from contamination from metal fragments.
- The failure to establish specifications for their dietary supplement labels. Specifically, the investigator found that they do not have label specifications for all of their products.
- The failure to make and keep records of a material review and disposition decision on a returned dietary supplement.
- The failure to make and keep adequate documentation of calibrations for instruments used in manufacturing components in the dietary supplements.
- The failure to make and keep documentation, including the person(s) trained, to ensure that each person engaged in the manufacturing, packaging, labeling, or holding, or in performing any quality control operations, has the education, training, or experience to perform the person’s assigned functions.
- The failure to make and keep documentation of the date of the use, maintenance, and cleaning of equipment, unless such documentation is kept with the batch record.
- Numerous misbranding issues related to allergen, ingredient and dosage declarations along with other labeling violations. Also, their Protein Factory® Zip™ product was found to contain an unsafe ingredient (desiccated thyroid gland extract) and the source was not listed. The term “dietary ingredient” does not include substances which humans avoid ingesting because they are not safe. Regulations prohibit thyroid glands from use as human food.1
Demand Quality Manufacturing!
In all honesty, it’s tough to know which manufacturers are legitimately compliant. Even in the case above, the Theta Brothers Sports Nutrition’s website, proteinfactory.com, states, “The World’s Highest Quality Proteins, Original, Pure, & Unmatched” and “Registered & Inspected by the U.S. Food & Drug Administration”.2 Statements like these invoke our trust, unfortunately the FDA’s inspection has shown us the statements may not be entirely accurate. This is proof that professional-looking graphics, packaging, and crafty statements can deceptively hide poor manufacturing processes which endanger the clients who consume those products.
The FDA has increasingly stepped up enforcement and inspections of nutraceutical manufacturing. Warning Letters that the FDA sends to non-compliant facilities can be viewed here.
I personally recommend Natural Products Association (NPA) Certified manufacturing facilities. The NPA GMP Standard has been revised to include all of the FDA GMP requirements of 21 CFR Part 111 and retains certain requirements from the 2000 version of the NPA GMP standard that exceed requirements of the FDA GMPs, or reflect best industry practices, and/or are necessary for the evaluation of compliance to the NPA GMP standard. NPA GMP Certification is awarded to companies that meet a high level of compliance to the NPA GMP standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation.3
Don’t be hesitant to ask the tough questions. Most nutraceuticals are MANUFACTURED FOR supplement companies. This means that many of the brands you see at the store or online are probably not made by the company whose name is boldly displayed on the product. Don’t worry, this is entirely normal. However, you should always demand to know whether or not a company’s product is produced in a certified and compliant FDA CGMP facility, and optionally (albeit more importantly) if it’s produced in a Certified NPA GMP facility. If you don’t get a straight and definite answer, I highly suggest you refuse to purchase nutraceuticals from that particular brand. Companies that solely use NPA Certified manufacturing facilities may not be plentiful, but they are out there and I can personally attest that they carry products for every lifestyle, even the muscle heads!
Remember one thing – buy QUALITY, not hype!
1 U.S. Food and Drug Administration Inspections, Compliance, Enforcement, and Criminal Investigations. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm299891.htm. Accessed on 04/18/2012.
2 Protein Factory®. http://www.proteinfactory.com. Accessed on 04/18/2012.
3 Natural Products Association. http://www.npainfo.org. Accessed on 04/18/2012.
Protein Factory® is a Registered Trademark of Rogers, Alexander.