“Lief Labs was built on a platform of transparency and we expect the same level of transparency and adherence to regulatory guidelines of the brands and companies with whom we work and partner,” Adel Villalobos, Lief’s founder and CEO said. “A lack of knowledge and non-compliance with FDA regulations places a brand’s reputation and inventory at risk and can also lead to product recalls and account suspension on vital distribution channels, such as Amazon. Lief wants to help build brands that are not only innovative, sustainable, and marketable, but also industry compliant, and we’ve developed the GMP Starter Kit to put companies on the right path to cGMP compliance from the start.”
The guidance kit includes three documents detailing standards of procedure for contract manufacturing organizations, adverse events reporting, and preparations for a product recall. This includes examples of key documents, procedures, and breakdowns of the necessary GMP regulations.
When starting a relationship with Lief Labs, brands will be provided with this GMP Starter Kit for free, so that they can get their regulatory framework and quality unit started. Following this, brands will also have the option of purchasing several additional critical standards of procedure, which offer a range of compliance initiatives that can be used to start off a regulatory compliance program.
“We are a highly regulated industry,” Villalobos told Nutraceuticals World. “Regulations have complexity and Lief feels that healthy competition is one where we all know the rules. Lief loves this industry and we are very competitive at wanting to own the market share. But we also want everyone to play by the rules. It doesn’t feel good to win when your competitors are not up to par. We feel that we’ve just raised the bar.”
Villalobos said that brands engaged in a greater level of self-regulation are advantaged in that they have more direct knowledge of how to actually implement guidance in a way that is beneficial not only to end product, but most practical to manufacturers. Additionally, he believes that the industry has a long way to go in the realm of transparent relationships between suppliers, manufacturers, and brands.
“Self-regulation in collaboration with FDA regulations is a much stronger industry. Also, we are in the industry. We should do a better job than other agencies,” Villalobos said. "Transparency is still in its infancy. In all industries. There is still a big gap between brand/CMO (Contract Manufacturing Organization) transparency. It all started with a buzz word 'transparency' in our industry. Competition will help drive this. Tomorrow’s business relationships will require it. It will take a massive cultural shift within our industry’s entire supply chain for transparency to really come to fruition. Luckily, Lief has been transparent with its clients from Day 1. It’s in our DNA. That is why we provided the GMP Starter Kit. That will be common practice from all CMO to brand relationships. Lief will be building a transparency platform of the future while our competitors catch up with just basic GMP’s as they relate to their clients.
The ongoing COVID-19 pandemic has placed serious strain on FDA’s capability to enforce its own GMP regulations in the interim. The agency has suspended many of its critical enforcement practices, at least in terms of any on-site inspection that ordinarily takes place in manufacturing facilities, placing a heightened need for supplement manufacturers to self-regulate. Villalobos said that the dietary supplements industry is, however, more well-equipped than other markets reliant upon manufacturers due to the fact that the onus has long been on companies to police themselves.
“Remember, it took the FDA ten years after DSHEA (Dietary Supplements Health and Education Act of 1994) to publish its GMPs and a total of 16 years to finally become law. Whereas NPA (Natural Products Association) had published self-policing GMPs years ahead of the FDA.