Pro Pac Labs

Source: Manufacturing Digital

Date :23/05/2007 11:43:06

Pro Pac Labs: Regulating a Level Playing Field

Written & produced by James Buchanan & Patrick Harlow

Pro Pac Labs believes the nutraceutical industry urgently needs new regulations to ensure the integrity of the market

While it may seem counter intuitive to hear any company say it is eagerly anticipating enactment of industry-wide regulations, Pro Pac Labs believes such regulations are in its and the industry’s best interests.

Nutraceuticals (commonly known as vitamin and/or herbal supplements) are largely unregulated within the US, leaving the door open for a few manufacturers and marketers to take advantage of the system.

Therefore, Pro Pac, which operates with the highest certification of its manufacturing process, wants to see industry-wide regulations enacted.

“The industry has made the mistake of not self-regulating enough,” says Kim Wheelwright, VP and CEO of the Ogden, Utah-based company. “Products from some other companies were not what they were supposed to be or were not in the correct concentrations to be as affective as advertised, which has been a black eye on the entire industry.”

However, Pro Pac adheres to the highest of standards and uses its quality assurance processes to promote the business and single itself out as an international leader in the nutraceuticals industry.

Quality as Growth Tool…

For 25 years Pro Pac Labs has been a contract manufacturer of nutraceuticals, which is a portmanteau of the words “nutrition” and “pharmaceutical.” The nutraceuticals the company produces are vitamins and minerals, acidophilus (probiotics), and drink mixes such as protein and meal replacement drinks.

The hybrid nature of these products – exemplified by the blend of terms to form “nutraceuticals” and that they are considered medically beneficial foods – is one of the reasons why they have fallen between the US government’s regulatory fingers. Nutraceuticals don’t neatly fit within the regulatory regimes for either food or drugs.

This does not mean that the industry is completely unregulated. Nutraceuticals are regulated by the US Food and Drug Administration and the Federal Trade Commission. They also must comply with regulatory regimes within all of the 50 states.

Where the regulatory issue becomes somewhat cloudy is that nutraceuticals are regulated as a category of foods under the Dietary Supplement Health and Education Act (DSHEA) enacted in 1994. The controversy arises because nutraceuticals often come with claims of health benefits, but these claims and the nutraceuticals themselves are not regulated like drugs.

According to the Council for Responsible Nutrition, a trade association that represents ingredient suppliers and manufacturers in the dietary supplement industry, if these products were regulated like drugs, many products would not exist, and those that did would cost what drugs cost.

According to Wheelwright, nutraceuticals can be thought of as a first step prior to medical treatment to maintain overall health or address a specific health issue such as digestion. Where regulation is lacking, he adds, is in the area of good manufacturing processes (GMPs). These are rules that would ensure the safety, purity, and effectiveness of nutraceuticals throughout the industry.

There are no regulations in this area that are specific to the nutraceutical industry in the US.

But this should change relatively soon.

GMPs have been created, says Wheelwright, but so far have not been adopted. This lack of clear regulatory guidelines in this area is what has left nutraceutical producers within the US to largely self-regulate.

This is not the case in other countries. For example, Australia is commonly accepted as having the highest regulatory standards for complementary medicine (nutraceuticals) GMPs in the world.

In anticipation of adoption of standards in the US, Pro Pac jumped ahead of the curve by working to adhere to the Australian criteria and earning that country’s Therapeutic Goods Administration (TGA) certification. These are the strictest in the world and require biennial audits by Australian inspectors in order to receive and maintain the certification. TGA certification also requires testing of products throughout each phase of production.

Following the Australian system enables the company to sell its services in Australia and other countries around the world. It also raises the bar for the company making it more attractive to national and international marketers; especially those in countries with comparatively stringent criteria for GMPs.

“The result is that people recognize that you have gone out of your way to improve your manufacturing process and capabilities,” says Wheelwright. “This brings world class customers to your door and gives your company more credibility.

“However, it also increases the cost of manufacturing, which makes us more expensive than some of the other companies in the US; especially those that haven’t adopted the GMP standards.”

To address the cost issue, the company has implemented lean manufacturing techniques under Kaizen continuous improvement principles. “It’s not like you just open the book and say you’re going to be lean today,” says Wheelwright. “It is an ongoing process to reduce waste and increase efficiency, which comes with long-term cost benefits. Also, a lot of the lean cycle processes are similar to those required for our TGA certification.”

The goal of lean manufacturing is to minimize extraneous processes from the production flow. In particular, Pro Pac focuses on:

• Continuous improvement

• Producing products with a 100% quality rating

• Customer satisfaction

• On time deliveries

• Housekeeping

• Good material flow, from receipt to shipping

• Elimination of non-value added processes

• And people involvement

In the US, there are a few other companies that can claim TGA certification, which Wheelwright takes as a sign that the industry is coming to the realization the nutraceuticals industry is going to have to raise the bar eventually.

“We are anxiously awaiting these regulations coming to the US,” says Wheelwright. “We’re looking at it as a competitive marketing tool. When the rules and regulations are signed into law, people marketing nutraceuticals will want manufacturers that are already up to speed with the new standards.

“Because we are already there, it will be an instant marketing tool for us. Being ready before the regulations come into effect allows us to sell internationally now and gives us the edge over other US companies that have yet to move on them.”

Wheelwright adds that the quality processes put in place for certification have been a major component of the company’s growth. Initially, the company only handled co-packing for marketing companies, which is encapsulating and packaging various nutraceuticals.

The company then was driven to learn how to make tablets and saw a niche in this service as there weren’t many companies in the US providing it. This required Pro Pac to learn granulating, tableting, and coding.

After perfecting tablet manufacture the company moved on to formulation design.

As Pro Pac grew with each new service, it was able to attract larger and more sophisticated clients with more requirements for the products they wanted. This, in turn, led the company to implement a quality control system, which became a niche within its growth plan and led Pro Pac to become TGA certified.

Among the quality control systems implemented by the company is constant oversight of the raw materials used in its products. In particular, the company:

• Has a vendor certification program

• Raw materials are identity tested and also tested

for microbial contaminants

• Final microbial testing is conducted prior to release

• And product testing throughout all phases

of production

All of this attention to detail has paid off as Pro Pac now works for large multi-national companies. Wheelwright is unable to provide specific examples as they have signed confidentiality agreements, but he did say some are household brand names.

The countries the company sells its services in are Australia, China (including Hong Kong), Japan, Korea, Mexico, Canada and others.

A Few Bad Apples…

One of the critical challenges Pro Pac faces is the perception of the industry as not effectively ensuring the quality of its products due to lax regulations.

In the past, and to this day, says Wheelwright, nutraceuticals have landed somewhere between regulations for food and drugs. They are made of organic ingredients as opposed to medicines, but often marketed as having certain healing or health related benefits. Therefore, should they be held to the highest standards that medicines in the US must meet, or something less stringent on a par with regulations for food producers?

According to Wheelwright, some manufacturers have taken advantage of this gray area to produce products with ingredients that do not match the claims on the label. Others have unintentionally been led astray by unregulated suppliers. Ergo, the black eye for the industry.

“If people are shortcutting their products to get into the market, the drug companies will get their hands on that data and publicize it,” says Wheelwright, “which hurts our industry. This is why the US regulations need to come into law, to put all of us on a level playing field.”

In the meantime, Pro Pac’s strict adherence to GMPs and maintaining its TGA certification provide it with a marketing tool and insurance to its customers that they are a credible and quality manufacturer.

“The last thing a marketing company wants is to be tested and not meet their claim on their products and be exposed,” says Wheelwright. “I want my industry to be ethical and honorable so that negative things cannot be published because they simply are not true.”

Pro Pac is also cGMP compliant and registered with the US Food and Drug Administration.