In the years leading up to the publication of 21 Code of Federal Regulations (CFR) Part 111, aka cGMPs (current good manufacturing practices), the dietary supplement industry was accustomed to secrecy in the supply chain. The words “proprietary” and “confidential” were used in an overbroad attempt to deflect simple inquiries by brand owners into contract manufacturing practices or ingredient sources. On the other side, manufacturers were also burned by unscrupulous brand owners switching suppliers for pennies after working together for years.
This environment caused a protective cocoon to be placed around all aspects of these relationships, where little information other than the name and the amount of ingredients in a supplement made it to the brand owner, and even less found its way to the consumer.
Little changed from the “wild west” days of the industry, even after the implementation of cGMPs and the rise of certification bodies performing GMP audits. The GMPs made it clear the entire supply chain is responsible to ensure the safety and quality of dietary supplements sold to the public. Unfortunately, these facts were often ignored.
The marked change in attitude regarding transparency over the past few years is credited to educated consumers demanding to know what is in the products they buy. We all have seen how consumer issues such as non-genetically modified organism (GMO), organic, gluten free, pesticide free, vegan, vegetarian, etc. have helped to drive the mandate for greater transparency.
In response to consumer demands, most (but not all) brand owners have started taking an interest in how their supplements are made and what’s in them. This has forced contract manufacturers to be more open about how supplements are made. For instance, until a few years ago, very few contract manufacturers shared batch records—everything done by the manufacturer was considered “proprietary” because the manufacturer was often shared with other contract manufacturers by a brand owner looking for a better deal. Fortunately for the industry, progressive contract manufacturers took the risk in disclosing this information to trusted brand owners, offering full visibility into how their supplements were made. This altered the paradigm, where the brand owners were now vested partners in the process and unlikely to move their business since they were able to appreciate the value in relationship.
Even today, some contract manufacturer hold-outs still live in the past (don’t operate in a transparent manner), and this overall change in the contract manufacturer to brand owner relationship has opened the door to the growth of this industry. Now, brand owners play an active role in all aspects of the sourcing and production of their products. Utilizing such tools as supplier audits have given brand owners greater confidence in the quality of their products. This knowledge can be conveyed to the consumer quickly and accurately.
The “final frontier” of this supply chain are the ingredient suppliers. Since none of the dietary supplement regulations (intentionally or not) were designed to include ingredient suppliers, they have been exempted from transparency. While certain ingredient suppliers are forward-looking and industry initiatives like the Standardized Information on Dietary Ingredients (SIDI) are making progress, ultimately the burden of trying to ensure the ingredients are correct has fallen to contract manufacturers.
Even today, things as simple as the carrier used for an extract may not be found on ingredient certificates of analysis (CoA) or the ingredient specification sheets. Often generic ingredients purchased through brokers are sadly lacking in detail, including the name of the company producing the ingredient.
However, few pressure points are being applied to the raw material supply chain from a marketing and a regulatory perspective. To get a premium for their product, branded ingredient suppliers are keen to differentiate their products from their generic counterparts. While careful to not give away all their secrets, branded ingredients are invested in being more transparent about the sourcing, creation and content of the ingredients and their potential benefits to the consumer to extract a premium price for their product. This “trickle up” serves to help educate others about the availability of this information for other ingredients, and thus has been a net positive in the supplement industry. Additionally, the requirements under the Food Safety Modernization Act (FSMA) will further open doors to what is in the raw materials used in dietary supplements.
Although only picking up pace over the last few years, the implementation of 21 CFR Part 111 has evolved industry into one that has gone from closed doors and secrets to one that is more transparent. This has provided for a safer and better supply chain with an overall increase of trust of supplements. The industry isn’t fully evolved because some companies still don’t commit to full transparency. The good news is there are far fewer of them today than there were five years ago, and it’s improving each day.
Michael Finamore is CEO of Gemini Pharmaceuticals Inc., a contract manufacturer of both dietary supplements and over-the-counter (OTC) pharmaceuticals for more than 30 years. All Gemini production is carried out in a pharmaceutical cGMP (current good manufacturing practice) environment.