Call Us Toll Free (800) 688-5956

Seeing suppliers as true partners is key to successful business continuity planning

A business continuity plan is essential for every company, but this is especially important for contract manufacturers that depend on outside sources for ingredients and packaging components. With the globalization of the industry, and the way the nutraceuticals industry’s supply chain works across international boundaries, and with late delivery potentially causing a halt in the manufacturing process, contract manufacturers must have plans in place to ensure smooth operation. Contract manufacturers rely on raw material vendors and packaging suppliers to make products, so it is imperative that the finished brands know that their contract manufacturers have a plan to deal with out-of-stock situations. Addressing any issue, whether it is from a distribution error or logistical delay, manufacturers must continue to provide brands with consistent on-time delivery.

The industry must adhere to GMPs (good manufacturing practices) and proactively mitigate risk. This means not only making primary suppliers accountable to very high standards (i.e., strict incoming raw material requirements), but also pre-qualifying secondary and tertiary suppliers.

Working with suppliers closely to verify that raw material requirements are being met is a key factor, but the relationship also has other benefits. A well-researched and reliable supply chain should lead to excellent two-way communication. For example, being warned promptly of any likely delays or issues gives more visibility and extra time to make other arrangements, which means contract manufacturers can continue to supply products on time.

Both consumers and brand owners have an understandable increased interest in the integrity of the supply chain for nutraceuticals. The types of ingredients that go into the product and the fillers or additives used are increasingly drawing consumer attention. For example, consumers want to know if supplements are vegetarian, non-genetically modified organism (GMO) and/or natural. These issues are more acute for brand owners, and they need assurances about the ingredient’s purity and identity as well as heavy metals and microbial content to ensure the highest quality finished product.

Building a true partnership with suppliers means they look after contract manufacturers’ interests and communicate information about new, trending ingredients so that manufacturers can continue to innovate for brand owners. In fact, through these partnerships on many occasions, contract manufacturers are among the first to hear of new ingredients coming to market.

Moreover, it is always good practice for brands to ask their contract manufacturers about their relationships with suppliers. Brands should ask questions about the strength and length of their relationships, and inquire about the systems they have to check beyond the certificate of analysis (CoA) that is normally provided by the vendor. Another important question to ask is if contract manufacturers use a trust and verify policy with ingredient suppliers; i.e., do contract manufacturers test incoming batches and undertake onsite audits at least once every two years?

Read The Full Article HERE

Astaxanthin for muscle endurance and recovery

Post-workout recovery supplements replenish energy stores, promote muscle repair and reduce muscle breakdown after a demanding workout. Intense physical exercise is energy-dependent. When the muscles burn calories by oxidation, free radicals and other reactive oxygen species (ROS) are formed as a byproduct.1 Free radicals can damage muscle fibers and reduce their ability to contract.2

Moderate exercise has health-promoting effects, while strenuous exercise, especially in unfit individuals, may have the opposite effect. Physical activity enhances metabolism that leads to increased production of free radicals and other ROS.

Astaxanthin sourced from the microalgae Haematococcus pluvialis is a powerful natural antioxidant. Comparison studies have shown astaxanthin is 6,000 times more powerful than vitamin C, 100 times more powerful than vitamin E, and five times more powerful than beta-carotene in trapping energy from singlet oxygen, one of the most common ROS in biological systems.3 Astaxanthin can trap several types of ROS/free radicals. In addition, the way astaxanthin neutralizes harmful ROS/free radicals is gentle to the body’s cells. Other antioxidants can be harmful, since they may turn into highly reactive molecules.4

As a bioavailable antioxidant, astaxanthin is transported throughout the body to organs and muscle tissues, combating excessive free radical production. Natural astaxanthin improves muscle endurance and strength by helping to reduce oxidative stress. Clinical studies have found natural astaxanthin neutralizes exercise-induced free radicals, protects the activity of antioxidant enzymes, reduces muscle fatigue and inhibits the formation of lactic acid.5-9

Read The Full Article HERE

Supply chain transparency: A practice of trust through legitimacy, from ‘farm to fork’

Supply chain transparency A practice of trust through legitimacy from farm to fork

How important is supply chain transparency to supplement brands? The level of its importance determines the level of the business’ growth and success. Supply chain transparency builds trust through legitimacy across the board–trust with suppliers, employees, customers and oversight agencies. Are you transparent in the chain? Are others transparent with you? More importantly, how high is the trust level within the chain? Have you ever suspected “deceptive documentation?”

Supply chain transparency is the disclosure and transfer of credible, accurate and truthful information from one supplier to another through the chain of products and services down to the end user. Specifically, in the dietary and food supplement industry, this could mean raw material originating from a farm; shipped or delivered to a raw material supplier or processor, then to a manufacturer; then finished product shipped to a distributor or direct to consumers. A commonly used phrase to describe this chain is “from farm to fork.”

Supply chain transparency is embedded in supply chain management that dates to the early 1900s, according to the supply chain management site SupplyChainOpz. As this network of business evolved, so did the need for dependence on each segment or entity to provide truthful and credible information in order to traverse the continuous flow of exchange of materials and goods through both foreign borders and domestic marketplaces.

The need for supply chain transparency is a demand being placed by consumers who want to know exactly what’s in their supplements, their sources or countries of origin, and how all the associated components were handled and distributed.

Over the last decade, increased attention from regulatory and compliance agencies resulted from a spate of food-safety issues and heightened threat of bioterrorism, as evidenced by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), signed into law by President George W. Bush on June 12, 2002.

As a result, conducting an internet search for information on supply chain transparency today, will result in an overwhelming plethora of information, enough to keep one occupied at length. Whether this represents an emerging trend or a growing corporate awareness of consumer desires might be less debated given the climate of business-related human rights concerns also associated with supply-chain activities (e.g., child labor, forced labor, slavery and human trafficking). Consumers are not the only ones concerned about transparency.

Congress is just as concerned about supply chain transparency, traceability and disclosure requirements demonstrated in the Business Supply Chain Transparency on Trafficking and Slavery Act of 2014 (H.R.4842) introduced by New York State Rep. Carolyn Maloney (D-12). Further, FDA’s enforcement measures have caused the industry to pay more attention to supply chain management and transparency.

Read The Full Article HERE

Ensuring supply chain integrity before beginning supplement operations

Ensuring supply chain integrity before beginning supplement operations

In this remarkable age of international supply chains, instant transmissions of electronic information and voice communications, and the varied impositions of tariffs by different governments, the need for supply “country of origin” transparency has never been greater.

Recent statements from FDA Commissioner Scott Gottlieb, M.D., showed the agency believes it needs to step up its enforcement of the abuses of the dietary supplement industry that have been exposed in recent years. Concerns associated with imported goods remain, including the undisclosed presence of active pharmaceutical ingredients or their analogs, which have been identified by agency laboratories. The agency realizes to safeguard the consumers, it needs to step up enforcement of quality checks for imported materials.

One mechanism of this guardianship is the policing of new dietary ingredient (NDI) submissions by issuing timely acknowledgements of notification acceptance and better managing import alerts to customs and border officials to prevent adulteration, misbranding and potential harm to the consumer. This mandates transparency in the supply chain and honesty in disclosure documents.

Supply chain integrity rests squarely with the finished brand, which is tasked with the selection, handling, testing and processing of ingredients and components, as well as the composition, dose and shelf life of the finished product, whether it be a powder, liquid, tablet or capsule or in confectionery form. This elevation of responsibility was defined in statute with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the subsequent imposition of the cGMP (current good manufacturing practice) requirements.

What remains a mystery is why almost half of the cGMP inspections conducted annually by FDA still result in either official or voluntary actions being taken by the firms inspected to correct deficiencies in some of the most basic components of a cGMP system, according to information obtained in a Freedom of Information Act (FOIA) request.

Supply chain transparency, or lack thereof, can contribute to significant problems with the agency and the products intended for commerce. Either producers of products in our industry are naïve, or they are willfully ignorant of their responsibilities. In certain circumstances, importers are willfully ignorant of what is in their products. Those that engage in such deception should be met with the full force of federal law, and the offending products should be subject to immediate seizure, no matter where or how the products are being sold in the United States.

Read The Full Article HERE

Supply Chains & The Trust Transparency Paradigm

793_main

Transparency has become a reality, not an aspiration, in today’s marketplace. Understandably, customers and consumers in the dietary supplement industry have learned to expect more from companies, and are becoming progressively more demanding.

Ingredient manufacturers are becoming the cultural pivot point for change, and supply chains have been the focus of improvement. Expectations about transparency are eclipsing the rate of change though, as demand for more information increases. While companies seek openness from their supply chain, what they ultimately want is the trust of their consumers. To that end, we present here the paradigm of trust transparency—the intersection point of trust and transparency—which is a proactive and top-of-mind strategic approach to creating a process and value system that aligns organizations and their internal and external partners to develop tangible, quantifiable ROI.

There are many obstacles to overcoming perceived deficiencies in supply chain transparency including:

  • Inertia & Status Quo
  • Culture
  • Competitive Environment
  • Technology/Geography

Inertia & Status Quo
Today’s supply chain is still opaque, but slowly moving toward more transparency and clarity. It’s easy to maintain information privately that hasn’t traditionally been shared. Historically, we’ve been taught that we don’t get in trouble for what we don’t say. Today though, what is not said can be as damaging as what is. Consumers and society are shifting attitudes to require a responsible dialogue of truthful representation at an increasing level of accuracy. It is essential to recognize the shift in expectation and understand the need for both good and bad information to be shared.

Culture
Our supply chains traverse a variety of cultures that offer varying levels of transparency. To excuse misinformation or incomplete information as a product of culture, or translation of words or ideas, is not acceptable in today’s market. It’s our responsibility to educate about the importance of transparency and not enable, excuse, or accommodate a culture that is not open to disclosure. Rather, we should make it a point to reward transparency initiatives.

Read The Full Article HERE

ncl-made-in-usa
ncl-fda
ncl-gmp-certified

For more information call (800) 688-5956 or Contact Us for a Free Quote!