Nutritional supplementation is a personal choice. If an athlete or client asks me about supplements, it is my responsibility to guide them in the right direction. Nowadays, with all the publicity from baseball and other sports about steroid use, there is a lot of confusion. It is possible to take a supplement bought at the local store and test positive for an illegal substance in your sport (if you get drug tested). Not all of the banned supplements are steroids, they are just banned for one reason or another by the governing body of your sport.
I have decided to partner with Inbounds Athletics. They are the only company that sells lot tested supplements. They guarantee that their supplements do not have any banned substances in them. This is the only way to know for sure that your supplements are clean. Check the link below and read the article to get a better grasp on what they do or to look at their supplement selection.
Life Story of a Nutritional Supplement, and Lot-to-Lot Testing for Banned Substances
Jonathan Toker, Ph.D.
Buy a bicycle and you may need to register the serial number with the police department. Buy a pair of socks and there's no serial number. Why do bicycles contain what is a unique identifier while socks do not? The simple answer is that consumers, manufacturers, and regulatory agencies are often best served by being able to track the journey from sourcing to manufacture to consumption and repair of specific consumables, while in other cases it is not practical or necessary to do so. Nutritional supplements also contain a unique identifier. A lot number is assigned to a batch of product that has been produced, packaged and handled in an identical manner, such that any part of the lot should be identical to any other part of the same lot. By the same definition, a given lot is unlikely to be exactly identical to any other lot due to slight variations in ingredients, processing, packaging, handling or transport, depending on the specifications and care provided.
Consumers generally take for granted that the content inside a bottle of a supplement matches exactly the label on the outside. Fortunately and for the most part, thanks to the US Food and Drug Administration (FDA) rules currently in place, this is true. However, there are multiple opportunities during production where the contents of the bottle may no longer be represented correctly by the label, and that the contents may contain more or less of the ingredients than stated, or may be contaminated with other materials. Most nutritional supplement companies source their products from a limited number of contract manufacturers. The best practices of these companies vary as much as in any other industry served by different companies. The result is that the end product can also vary between manufacturers, and even between lots produced by the same manufacturer. What follows is a brief summary of the life story of a nutritional supplement, and identifies sources of variability between lots, followed by a discussion on the importance of lot-to-lot testing and its importance to athletes.
From start to finish at a contract lab
a) Starting Materials
Most contract labs source their raw materials from a wide range of outside suppliers, many of whom specialize in certain classes of materials, such as amino acids, protein powders, minerals, etc. Each supplier provides to the contract lab a certificate of analysis (COA) that is issued for each and every lot (batch) of raw material. Suppliers can be located overseas or domestically with the actual starting material produced anywhere around the world.
When raw materials are received by a contract lab, they should be positively identified. This is usually done easily and quickly by near infrared (NIR) spectroscopy. By matching a characteristic fingerprint spectrum of the raw material with a reference spectrum for the material, identity can be confirmed. Purity (the percent active content of the material) is not usually assayed at this time, depending on the COA of the material for this and any other details. This is the first intersection where impurities that originated in the starting material factory or packaging would enter the contract lab undetected. Note that the NIR identity confirmation is not sensitive to pick up foreign matter in the raw material and is a bulk test only.
b) Processing of ingredients
Once the raw materials are identified upon receipt, the contract lab prepares the formulation according to specifications required by the supplement company. This can include dry mixing, wet mixing, granulation, and other physical handling steps. Containers used for these processes are part of machines that can be manually or automatically operated. Often made of stainless steel parts, these complex mixing bowls are used for a given batch and then cleaned and readied for the next product, one that may be totally distinct from the batch before and after it. Most contract labs will follow a set of Standard Operating Procedures (SOPs) that dictate how the machine is to be cleaned, rinsed, and dried. Some facilities conduct a “cleaning verification” whereby some of the rinse wash is tested for the active ingredient from the previous batch. Possible source of contamination #2 arises if a machine is incompletely or incorrectly cleaned leading to carryover from one product to another. In this way, for example, a steroid material from one product batch could be carried over to a protein supplement in the next batch of processed product.
c) Encapsulation/bottling/packaging of the product
The final step within the contract lab takes the mixed product into its final form for the consumer. This can include bulk powder in plastic tubs, pressing powder into pills, or filling capsules with powder. Once again, industry-specific machines are used for this step. Careful cleaning between batches of different product is critical to ensuring no cross-contamination between products. Once the product is in its final packaging, a quality control (QC) unit serves to qualify and inspect the final product. Once again following SOPs, the QC analyst inspects the product against specifications that can include fill weight, color, particle size and other physical characteristics.
Lot-to-lot testing and WADA prohibited substances
The above discussion shows several sources of variability that can originate in the manufacturing facility. Once the final product is packaged, it is assigned a unique lot number and expiration (or best by) date. A batch record is maintained for this lot, and a certificate of analysis (COA) is issued by the manufacturer for this specific lot. It is important to note that the COA and manufacturer testing is nearly always limited to basic analytical testing, heavy metals, and possibly purity. This COA does not bear any relationship to testing for banned substances. The lot information is then traceable through the batch record, back to each and every step of sourcing, raw ingredients, instrumentation and machinery used, and packaging material. This is the nutritional supplement industry's equivalent to a person's medical records. The potential introduction of contaminants, harmless or otherwise, can also occur in a multitude of instances, so that in fact each lot originating from the facility has some natural variability. It is only by testing a sample of each and every lot that the safety of product across all lots can be assured. Many products are not tested after manufacture. Other products may have a random sampling of only some lots. Only a COA specifically issued for the negative presence of banned substances is your assurance that testing for banned substances has been conducted.
The bottom line:
Athletes concerned with banned substances should restrict their purchase of a product to those tested under reputable programs, and ensure that the specific lot they purchase has been tested. Some programs list specific tested lots on their websites and some manufacturers will also display the banned-substance-negative COA for specific lots on their websites. One online shop currently sells ONLY lot-specific tested products. Inbounds Athletics (www.inbounds-athletics.com) has lot numbers listed and only tested lots are stocked and sold. Bottom line in this world of nutritional supplements is "buyer beware". Fortunately, help is available, and athletes should start by learning that not all lots are created equally.