New Jersey-based supplement manufacturer NutraBio CEO and Founder Mark Glazier said he started the company with the goal of making the highest quality supplements and using 100 percent transparency to help educate consumers. Here, James Gormley discusses with Glazier the challenges facing the supplement industry.
NIE: What are the biggest challenges to compliance and transparency for finished product manufacturers and suppliers: claims, GMP standards, sourcing, or something else?
Glazier: The biggest challenge I have as a manufacturer is sourcing raw materials. Setting up GMP procedures to insure that all raw ingredients meet strict quality specifications for purity, potency, composition and identity is only the first step. Actually achieving those specifications each and every time is where the challenge is. Since GMPs are not required for raw material manufacturers or suppliers it is incumbent on the finished product manufacturer to insure that quality specifications are met. After more than15 years as a manufacturer, we still return about 8 percent of raw ingredients due to not meeting specifications.
NIE: Concerns are sometimes raised about vendors and raw materials from the Asia Pacific region. What efforts and initiatives do you feel will improve the confidence of manufacturers, retailers and consumers in the quality and purity of these ingredients and suppliers?
Glazier: Manufacturers of finished supplements must set strict quality specifications for all raw ingredients and insure those specifications are met prior to being released into production. Consumer confidence is built by consistently producing safe, unadulterated and efficacious products. This requires qualification of ingredient manufacturers and suppliers followed by rigorous testing of each and every batch. Ronald Regan said it best: “Trust, but Verify.” It shouldn’t matter if the ingredient is from Shanghai, China or Hoboken, NJ; if it’s properly tested for purity, potency, composition and identity than the consumer will get a safe, efficacious supplement every time.
NIE: Analytical labs play an important role in testing for heavy metals, toxins and other contaminants. Discuss why this is so important.
Glazier: It’s simple: consumer’s safety and health. Heavy metals, microbial, contaminants can be carcinogenic, cause disease and have adverse effects impacting overall health. We must do whatever we can to prevent contaminated supplements from reaching the marketplace. It’s not just a regulatory issue but it’s a moral obligation. Analytical testing is critical for consumer safety.
NIE: What are clean-label supplements and what are some of the best examples of this trend today?
Glazier: There is no exact definition of the term “Clean Label,” so many interpretations have surfaced. Some believe it stands for a natural product with no artificial ingredients or chemicals, some include non-GMO and organic in the mix, while others believe it means transparency. Consumer demand for more label disclosure, simplification of the ingredients and removal of unrecognizable and non-desirable ingredients are driving the trend toward clean label.
In the sports supplement sector much can be done to improve transparency while developing greater trust with consumers. I’m a big advocate phasing out proprietary blends so that labels disclose true dosages of all ingredients. In addition, removing active ingredients from the fine print Ingredient Statement and putting them into the Supplement Facts Panel so that dosages are disclosed would be a big move toward greater transparency. This would force brands to properly dose active ingredients instead of hiding ‘fairy dusted’ dosages in blends.
Cleaner labels can be further achieved by removing magnesium stearate, silicon dioxide and other excipients that consumers are trending against. The fewer inactive ingredients and fillers added to product the better. The practice of hiding ingredients identities by using unknown names for common ingredients would also be a move in the right direction. For example, listing creatine as 2-(Carbamimidoyl [methyl] amino) acetic acid is confusing to consumers and causes distrust. Keep it simple. Cleaner, more transparent labels allow consumers to better understand what they are putting in their bodies while building greater trust in the industry.
NIE: What about ready-to-use premixes and semi-finished product for custom manufacturing? Are there special quality or transparency challenges inherent in product formulations such as these? Premixes pose a challenge quality and transparency.
Glazier: There are definitely transparency and quality challenges associated with using third-party premixes. I believe in full disclosure to the consumer and that includes listing all active ingredients along with their respective dosages on the label. The challenge with many premix manufacturers is getting them to disclose ingredient dosages rather than listing them as proprietary blends. I will not add a premix to my overall formula unless I know the dosage of each component so I can disclose it on our finished product. In addition, we require testing of all raw ingredients so without knowing the exact formulation, we can’t test the individual components of the premix to insure it meets specifications.
NIE: Discuss food and ingredient authenticity. What needs to be done to make sure that economic adulteration and other issues are addressed and overcome as an industry?
Glazier: There are many unethical and fraudulent practices used in the industry that are designed to cut product costs while disregarding consumer safety and product efficacy. With sports supplements, a widely used form of economic adulteration is a technique called protein spiking; a fraudulent practice where manufacturers add high-nitrogen ingredients to protein products to manipulate lab results so they can exaggerate protein claims. Imagine the consumer’s outrage when they find their favorite product only had 12 grams of protein instead of the claimed 25 grams.
Deceitful practices like this not only hurt the consumer, but also discredit the industry. Industry leaders need to take a stand against these practices. Trade organizations should work with federal agencies to expose fraudulent practices while encouraging them to take criminal and civil action. Educating consumers through articles like this one are a great start but more must be done. I have given hundreds of seminars across the country exposing industry fraud and educating consumers on how to understand labels. We are all in this together and if we want the industry to grow, we must work together.
NIE: Auditing, testing of food ingredients/supplements and training of production/QA/QC personnel. What do we need to focus on in these areas, big picture, and some best-case examples?
Glazier: As a 21 CFR Part 111-compliant dietary supplement manufacturer, NutraBio has gone through four FDA audits to date. In a GMP environment, written standard operating procedures is the critical first step toward GMP compliance but SOPs are only as effective as the person carrying them out has the ability to do so. Training of personnel is the key to maintaining a cGMP-compliant facility. We’ve learned that effective training starts with understanding the competency of personnel and their ability to carry out the procedures assigned to them. We start by defining tasks, insuring we have right person for the right task, and from there we train, retrain and then train again. We have a culture of constant improvement. It’s a feeling that we all have that isn’t force fed by management to personnel but realized and lived by all.
Audits are done frequently to monitor core competency of personnel and conformance with all procedures with steps in place to recognize and resolve non-conformance issues. The big picture to me is in realizing the effect we have on people’s lives. We’re not making paint for someone’s bathroom walls; these are chemicals that people are putting in their bodies. Cutting corners must be out of the question. Quality must trump all.
NIE: Full disclosure and transparency have become more important in the weight-loss/sports-nutrition area. What needs to be done to improve things?
Glazier: Label disclosure and transparency is next great challenge that the industry must overcome to protect consumers. With the advent of GMP regulations 21 CFR Part 111 for dietary supplements, there has been a lot of needed focus on manufacturing standards. Numerous third-party GMP certifications programs are now available and consumers are starting to take notice, but slapping a GMP seal on a label is a double edge sword. GMPs are an indication of quality manufacturing only. Quality manufacturing must go hand in hand with efficacious formulations; one without the other doesn’t protect the consumer.
Too many supplements on the market have severely under-dosed active ingredients but the consumer can’t recognize it because they are disguised by proprietary blends. If the product is manufactured to high standards and meets label claim, but the formulation is not efficacious, then what’s the sense, the consumer is just buying snake oil.
It’s time for brands to step up and start providing full label disclosure and transparency by eliminating proprietary blends. If a brand believes in their products, they should stand behind them by disclosing the dosages of all ingredients. Better transparency will help eliminate under-dosing, window dressing, protein spiking, bait and switching and other scams that have plagued the industry for too long. Consumers have the right to know what they are putting in their bodies. Full label disclosure protects that right.