Importance of Using a GMP Certified Supplement Manufacturer

HomeImportance of Using a GMP Certified Supplement Manufacturer

Importance of Using a GMP Certified Supplement Manufacturer

By Zachary Litton | Nutraceutical Industry News | 0 Comments | 17 November, 2017

GMP - Good Manufacturing Practices - they mean a lot to every product ever constructed or made, but in the dietary supplement industry that means a whole lot more. To fully understand the implications of GMP, this blog, looks at the role of a product as viewed through many lenses. 

Your Product and Its Viewers

Put a product on a shelf and you have an audience. It is not just the consumer who is looking though. There is a whole host of people who check out products. They include:

  • Your own QA team
  • Store managers and buyers
  • Governmental representatives
  • Your competitors

Selling supplements is a highly competitive industry so you must be careful when starting your own brand. Mistakes are common in the supplement industry but if you ask the right questions you should have success. Your competitors are looking at your products and hoping to find a reason to upsell you or remove you from the market. Store managers have limited shelving space and they only want the best products that fit into their buyer personas so they look at issues such as quality, labeling, and market fit. Government representatives look to make sure your product is meeting all of the rules and regulations, and there are a lot of rules and regulations. 

It is not as simple as just putting something in a bottle and calling it a supplement. Here is a closer look at why all the hoopla is critical.

Case Study - UFC Fighter Lyman Good

Professional athletes, such as Lyman Good, compete and are often tested for steroid and drug use that might give them an advantage over other athletes. That is where this case study begins. Lyman Good - Suspended for six months for testing positive for anabolic steroids. This ordeal began in mid- to late-2016. Lyman has always claimed he was innocent and unlike the murky layers that surround many athletes in his shoes, he might well be. Here's the deal.

Lyman used a supplement - Anavite - which is/was produced by Gaspari Nutrition and sold through Vitamin Shoppe, Inc. The problem is that the supplement contains an anabolic steroid that was not listed on the label and that fact was substantiated by the FDA and independent laboratories. It contained the very anabolic steroid to which Lyman tested positive. [2]

How Lyman Good's Situation Impacts Your Products

First, your product has long reaching impacts and in the case of Lyman, the supplement he used cost him significant damage to his career.

  • He will be ever in the shadow of this, even if he is proven innocent.
  • He has lost six months of his career, which is already a short span
  • He has suffered emotional and physical damage. 
  • He underwent extreme risk, unknowingly by taking an anabolic steroid that he claims he did not know he was taking and that comes with a very large increased medical risk and potential effects to his long-term health. 

These points showcase what bad consumer manufacturing can do to a consumer. As for the manufacturer, they are busy battling it out in court. 

Brand Impact of Bad Manufacturing Practices

There are many examples of vitamin and supplement recall situations. A few include:

When your product is recalled your brand suffers and it suffers in many ways. First, you lose consumer confidence and that just opens the door for your competitors to take your market share. Second, it can cost you big bucks both in civilian lawsuits and governmental fines or both.  A bad brand experience can also spread from one of your brands to the next causing more damage. On the other hand a GMP certified supplement manufacturer can help avoid many of these problems. 

What Do GMP Certified Supplement Manufacturers Mean to Your Brand?

One of the first things it means is quality. Certified GMP manufacturers understand the FDA's extensive rules and regulations, and help each of their suppliers meet those regulations. They too are at risk if your product is faulty. 

Other ways that a CGMP helps is by:

  • Uplifting your Brand in the eyes of both consumers and Retailers
  • Uplifting your Brand over competitors who cannot claim to use CGMP manufacturers
  • Reduce your legal and moral risks
  • Helps to product your brand from bad publicity such as the ordeal that Gaspari Nutrition is dealing with in the wake of the Lyman Good case.

In fact, a certified GMP manufacturer helps you to positively touch every lens that views your product and that is a powerful marketing tool. 

Does Your Manufacturing Process Meet the GMP Rules?

The FDA is watching closely and their rules and regulations are complex. How does your manufacturing process stack up against those rules? 

Read the Entire Rule Set Here - [1]

The spotlights for consideration include:

  • "Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers have an essential responsibility to substantiate the safety of their products and for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading." - FDA

In this case, the word manufacturer not only represents the company that bottles your product but the brand itself. You are ultimately responsible for your product. In addition, these rules help to define the relationship between the supplement manufacturer and the Brand as follows:

 

  • "The CGMPs will help to ensure manufacturers produce unadulterated and properly labeled dietary supplements.
  • Under the CGMP rule, manufacturers are required to:
    • Employ qualified employees and supervisors;
    • Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, labeling and holding;
    • Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
    • Establish and use master manufacturing and batch production records;
    • Establish procedures for quality control operations;
    • Hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light, and sanitation so that the quality of the dietary supplement is not affected;
    • Keep a written record of each product complaint related to CGMPs; and
    • Retain records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records." - FDA [1]

If we return to the case of Lyman Good and look at the bulleted quotes from the FDA above, you can see the legal framework and how it applies to not only his case but to your brand. Did Gaspari Nutrition use a certified GMP manufacturer? Manufacturers outside of the US are not held to US laws. They do not have to comply with FDA regulations, which puts the entire burden on the brand. 

The Power Behind the FDA's CGMP rules and regulation are all about prevention. Good Manufacturing Practices reduce the risk to consumers and in Lyman's case, those risks were significant. From the FDA -

  • "Examples of product quality problems that the rule will help prevent are:
    • dietary supplements that contain ingredients in amounts that are greater than those listed on the label dietary supplements that contain ingredients in amounts that are less than those listed on the label
    • wrong ingredient,
    • other contaminant (e.g., bacteria, pesticide, glass, lead),
    • foreign material in a dietary supplement container,
    • improper packaging, and
    • mislabeled" FDA [1]

Each of those points on the FDA's list is a potential disaster for private label brands and they reinforce the rationale for using a CGMP supplement manufacturer. Manufacturers also have the option of applying for exemption if they can prove that their process does not diminish the safety of their ingredients. The exact quote below is from the FDA [1]

  • "The interim final rule allows manufacturers to petition FDA for an exemption from the requirement of 100 percent identity testing of one or more dietary ingredients used in manufacturing the dietary supplement. The manufacturer would provide data to demonstrate that its proposed reduced frequency of identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient. Each petition will be considered on a case by case basis."

Does your current supplement manufacturer meet the CGMP guidelines? Can you afford not to use a certified GMP supplement manufacturer? How much risk does your brand create? As you answer these questions, research ABH Pharma as a GMP certified supplement manufacturer and their services. The cost of using a CGMP is much lower then you'd expect. 

Sources:

  1. https://www.bloodyelbow.com/2017/10/19/16504902/ufc-lyman-good-files-lawsuit-tainted-supplement-manufacturer-gaspari-nutrition-vitamin-shoppe
  2. https://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm#manuf

Nutraceutical Industry News

Zachary Litton

Written by Zachary Litton

Zach is a senior account executive here at ABH Pharma. Zach has years of experience working with both Supplement Brands & Manufacturers, giving him great insider knowledge of operations & sales methodology that works within this industry. Zach is constantly reviewing new product trends and listening to feedback from industry leaders to better his clients.

amazon tools & tricks e-book

Subscribe to Email Updates