Our vision is to enrich the world through the best of nutrition.
We are a leading formulator, manufacturer and marketer of nutritional supplements.
Our comprehensive strategic partnerships with our customers offer a wide range
of innovative nutritional products and services to our clients including the
following: scientific research, clinical studies, proprietary ingredients, customer-specific
nutritional product formulation, product testing and evaluation, marketing management
and support, packaging and delivery system design, regulatory review, and international
product registration assistance.
As our primary business activity, we provide private-label contract manufacturing
services to companies that market and distribute vitamins, minerals, herbal
and other nutritional supplements, as well as other health care products, to
consumers both within and outside the U.S. We also own a patent estate related
to the ingredient known as beta-alanine, which is primarily commercialized through
the direct sale of this raw material under our CarnoSyn® trademark.
Our U.S.-based operations are located in Vista and Carlsbad, California and
include manufacturing and distribution, sales and marketing, in-house formulation,
laboratory, and other research and development services. Our manufacturing facilities
were recertified on December 20, 2012 by the Therapeutic Goods Administration
(TGA) of Australia after its audit of our GMP. TGA evaluates new therapeutic
products, prepares standards, develops testing methods and conducts testing
programs to ensure that products are high in quality, safe and effective. TGA
also conducts a range of assessment and monitoring activities including audits
of the manufacturing practices of companies who export and sell products to
Australia. TGA certification enables us to manufacture products for export into
countries that have signed the Pharmaceutical Inspection Convention, which include
most European countries as well as several Pacific Rim countries. TGA certifications
are generally reviewed every eighteen to thirty six months. During August 2016,
TGA completed an inspection of our facility and quality systems for compliance
with good manufacturing practices, and a renewed 36 months GMP clearance is
expected in the coming months.
Our California facilities also have been awarded GMP registration annually since
October 2002 by NSF International (NSF) through the NSF Dietary Supplements
Certification Program and received “GMP for Sport” NSF Certified
registration on February 16, 2009. GMP requirements are regulatory standards
and guidelines establishing necessary processes, procedures and documentation
for manufacturers in an effort to assure the products produced by that manufacturer
have the identity, strength, composition, quality and purity they are represented
to possess. The NSF Certified for Sport program focuses on minimizing the risk
that a dietary supplement or sports nutrition product contains banned substances
and was developed due to growing demand from athletes and coaches concerned
about banned substances in sports supplements. The program focuses primarily
on manufacturing and sourcing processes, embedding preventative measures throughout.
NAI’s participation in the program allows us to produce products bearing
the NSF Sport logo.
Our U.S. operations have also been certified by Health Canada as compliant with
GMP requirements as outlined in Part 3 of the Canadian Natural Health Products
Regulations. Health Canada is the department of the Canadian government with
responsibility for national public health. Health Canada has initiated work
to modernize its regulatory system for food and health products. Health Canada
plays an active role in ensuring access to safe and effective drugs and health
products while giving high priority to public safety and striving to provide
information needed to make healthy choices and informed decisions regarding
one’s health. NAI was issued its initial certification in December 2011
and received its most recent renewal in November 2015. Not only does this approval
demonstrate another level of regulatory compliance for NAI, it may also ease
the approval process for our customers who import products into Canada.
During March 2015, our California facilities became certified as Organic Processor
and Handler by Natural Food Certifiers (NFC). This certification demonstrates
that we meet the USDA National Organic Program standards and allows us to expand
our contract manufacturing and packaging services to include Organic labeled
products. The certification requires annual renewal and we believe we will obtain
renewals annually. We are registered with the State of California, Department
of Public Health Food and Drug Branch as an organic processor. Additionally,
we are certified by various Rabbinical and Halal authorities to produce Kosher
and Halal certified products. These certifications guarantee that the facility,
processes, and ingredients of certified products have been reviewed and found
to be in compliance with the strict dietary laws of the respective Jewish and
Muslim communities
NAIE also operates a manufacturing, warehousing, packaging and distribution
facility in Manno, Switzerland. In January 2004, NAIE obtained a pharmaceutical
license to process pharmaceuticals for packaging, import, export and sale within
Switzerland and other countries from the Swissmedic Authority of Bern, Switzerland.
In addition to our operations in the U.S. and Switzerland, we have had a representative
in Japan for many years who provides a range of services to our customers currently
present in or seeking to expand into the Japanese market and other markets in
the Pacific Rim. These services include regulatory and marketing assistance
along with guidance and support in adapting products to these markets.
Our goals are to achieve long-term growth and profitability and to diversify
our sales base. To accomplish these goals, we have and intend to continue to
seek to do the following:
leverage our state-of-the-art, certified facilities to increase the value of
the goods and services we provide to our highly valued private-label contract
manufacturing customers and assist in developing relationships with additional
quality oriented customers;
expand the commercialization of our beta-alanine patent estate through raw material
sales, introduction of new products, new contract manufacturing opportunities,
license and sub-license agreements, and protecting our proprietary rights;
provide strategic partnering services to our private-label contract manufacturing
customers, as described below under “Products, Principal Markets and Methods
of Distribution”; and
improve operational efficiencies and manage costs and business risks to improve
profitability.
Overall, we believe there is an opportunity to enhance consumer confidence in
the quality of our nutritional supplements and their adherence to label claims
through the education provided by direct sales and direct-to-consumer marketing
programs. We believe our GMP and TGA certified manufacturing operations, science
based product formulations, peer-reviewed clinical studies and regulatory expertise
provide us with a sustainable competitive advantage by providing our customers
with a high degree of confidence in the products we manufacture.
While today’s consumer may have access to a variety of information, we
believe many consumers remain uneducated about nutrition and nutritional supplementation,
uncertain about the relevance or reliability of the information available to
them, or confused about conflicting claims or information. We believe this state
of the market creates a significant opportunity for the direct sales marketing
channel. The direct sales marketing channel has proved, and we believe will
continue to prove, to be a highly effective method for marketing high-quality
nutritional supplements as associates or other individuals educate consumers
on the benefits of science based nutritional supplements. Our largest customers
operate in the direct sales marketing channel. Thus, the majority of our business
has relied primarily on the effectiveness of our customers in this marketing
channel.
We also believe there is significant opportunity with the commercialization
of our patent estate through the introduction of CarnoSyn® beta-alanine
into additional markets and with the introduction of new beta-alanine product
offerings. Currently, a majority of our sales of CarnoSyn® are to companies
that operate in the sports nutrition channel and are focused on products containing
the instant release form of beta-alanine. We believe that there are several
other markets and distribution channels that represent growth opportunities
for the distribution of CarnoSyn® beta-alanine. We have also recently introduced
SR CarnoSyn®, which we believe is a superior form of beta-alanine based
on its sustained release profile that allows for increased daily dosing and
improved muscle retention of carnosine.
We believe our comprehensive approach to customer service is unique within our
industry. We believe this comprehensive approach, together with our commitment
to high quality, product development and manufacturing capabilities, will provide
the means to implement our strategies and achieve our goals. There can be no
assurance, however, that we will successfully implement any of our business
strategies or that we will increase or diversify our sales, successfully commercialize
our patent estate, or improve our overall financial results.
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