(Click here for part 1.)
Many sports nutrition consumers demand their supplements deliver instant and tangible results. To meet these demands, sports nutrition companies strive to keep up with supplement science.
Unfortunately, an unscrupulous few exploit market pressures to peddle products and ingredients adulterated with drugs or drug analogs, cheap and ineffective fillers, and dietary ingredients with no established safe history of use. Without due diligence, a company could unknowingly expose its consumers to danger and destroy the integrity of its brand.
A sports nutrition company that properly manages its Current Good Manufacturing Practices for Dietary Supplements (GMPs) responsibilities can set a baseline for responsible sports nutrition business practices and avoid unwittingly introducing adulterants into the market.
Though it happens infrequently, the intentionally adulterated raw ingredients sold for use in sports nutrition supplements should be a constant concern. When there are known economic adulterants (i.e., added to products for financial gain) for a supplement, due diligence requires that companies use GMPs as the basis for a strong framework of quality control processes.
Know Your Products
Although many sports nutrition companies contract with manufacturers to develop and manufacture their products, they still must understand the science behind and issues associated with their products to ensure they are safe, high quality, and free of known adulterants.
Companies must educate themselves about their products, the ingredients, and potential contaminants and adulterants. For sports nutrition products, known adulterants include drugs and dietary ingredients without a safe history of use. This includes ephedrine alkaloids, anabolic steroids, sildenafil, and sibutramine.
Get to Know Manufacturers and Suppliers
A sports nutrition company’s relationship with its contractors should be based on knowledge, not price. Qualify them to ensure they satisfy the minimum GMP requirements and meet all contractually pre-determined product specifications. Companies should visit potential contractor facilities and talk to the contractor about the relevant operations, GMP compliance, and any Food and Drug Administration (FDA) enforcement actions. Ask if they are GMP certified or use third-party auditors to assess and maintain compliance.
Due to the vulnerability of sports nutrition products for economic adulteration, when qualifying a contractor pay particular attention to how its manufacturers handle raw materials and verification testing for raw materials and finished products. Ask the company if and how it qualifies suppliers and determine whether the contractor will rely upon suppliers’ certificates of analysis (COA) and, if so, how they will be qualified.
Remember, a company may not rely on a COA without appropriately verifying the data. The appropriate verification method for a COA depends on numerous factors, including the prevalence of known adulterants and contaminants.
Provide Continual Oversight
Companies should continually oversee contractors operations to ensure compliance. Subcontractors, qualified personnel, and manufacturing operations, and sources of raw materials are not static. Connect regularly with contractors to exchange and review required information, inspect facilities and operations, and reiterate expectations. While this is not required, GMP agreements or quality agreements outline the responsibilities and expectations between a company and contractor to ensure that all GMP requirements are properly addressed.
A sports nutrition company’s GMP responsibilities do not end with its contractors. Companies must become familiar with 21 CFR 111 to determine the GMP requirements for those areas that pertain to their operations. Properly managing GMP responsibilities is vital to a sports nutrition company meeting consumer demands with quality products made from superior manufacturing and cutting-edge science.