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Press Releases
Press Releases
FOR IMMEDIATE RELEASE
Media Contact: Bret Hoyt, Sr., Vitakem Nutraceutical, Inc. 800-233-2112 ext. 1
Small Vitamin Manufacturers Supplying the U.S. Market Are Required To Meet FDA cGMP Requirements By The End Of The Month
Leading Contract Supplement Manufacturer Welcomes The Higher Standards And Consumer Confidence That Will Come With These Long Awaited Manufacturing Regulations
Smithtown, NY – June 22, 2010, Vitakem Nutraceutical, Inc. www.vitakem.com, a leading contract supplement manufacturer, today heralds the Food and Drug Administration's (FDA) final step in enforcing its current good manufacturing practices (cGMPs) for the vitamin manufacturers supplying the U.S. market. On June 25, 2010, small nutritional supplement manufacturers, those with less than 20 employees, are required to meet cGMPs. This is the final step in implementing a federal standard for nutritional supplement manufacturing practices.
"While plenty of manufacturers follow these protocols already because producing high quality, safe and effective products is their core mission, too many have cut corners and not put quality first," points out Vitakem President Bret Hoyt, Sr., "The industry's reputation has suffered from the shoddy or dangerous products created by a few bad apples. The new federally-enforced cGMPs give us a chance to change that image."
In 1994, the Dietary Supplement Health and Education Act (DSHEA) required the FDA to establish and enforce cGMPs. However, the FDA did not establish cGMPs until 2007. In 2008 and 2009 respectively, cGMP compliance enforcement began for large and medium-sized manufacturers. This June's requirements of small manufacturers mark the final stage. Many of these small companies use contract supplement and vitamin manufacturers to manage production and consequently are dependent on their manufacturing partner to meet the new requirements.
"Vitakem has been, for all practical purposes, following strict cGMP guidelines," explains Hoyt. Vitakem already applies written Standard Operating Procedures (SOPs) and protocols in their labs to insure quality control. And many of their employees are already familiar with cGMPs through their pharmaceutical background and Vitakem's long commitment to following GMPs.
"Other than some fine tuning of some of our labs SOP's," says quality assurance manager James Frahm. "The major change that Vitakem has undergone since the FDA implemented its cGMP guidelines has been in the analytical department. Our labs have purchased top-of-the-line analytical equipment."
Analysis is one of the key components of cGMP compliance. Raw ingredients coming into the manufacturing facility must be pre-tested for identity, strength, composition and purity. In addition to pre-testing of raw materials, manufacturers are also required to
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Test final products;
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Follow standard manufacturing processes to prevent contamination and maintain potency;
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Keep written SOPs on file;
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Regularly train key personnel on cGMP compliance;
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Package products appropriately and use accurate labeling.
Small vitamin and supplement manufacturers will face some challenges as cGMPs come into effect. Hoyt points out that the added cost of analysis required by the new regulations will increase the cost of production. And as nutritional supplement lawyer, Joel Rothman, noted in his January 2010 blog, "Companies that rely on contract manufacturing will receive a rude awakening as they are subject to regulatory scrutiny they have never previously experienced." Rothman, Hoyt and other industry experts predict that fewer small supplement companies will be around to see 2011 as a result.
For this reason, many small nutritional supplements are now looking to partner with a contract supplement manufacturer who is already prepared to meet these regulations. Furthermore, a good manufacturing partner may be able to help in cost savings through ingredient sourcing and more efficient production methods. Because of the specific needs of start-ups, Vitakem has created a division specifically devoted to helping very small companies get started.
Diana Pearson, recently partnered with Vitakem to start her supplement business. She says cGMP compliance and support in navigating the regulations was an important criteria for her in choosing a contract manufacturing partner for her first venture in the nutritional supplement market. "The regulations around nutritional supplements were a big concern of ours," says Pearson, "Bret and his sales team were very clear and explained the new cGMPs to us. We dealt with many companies in trying to find a contract manufacturer and Vitakem educated us more than anybody. They made it so easy for us. If I had to do it all over again, I would go right back to Vitakem."
For more information about current cGMP requirements for small nutritional supplement companies or to find out about contract manufacturing services, please contact Bret Hoyt Sr. at 800-233-2112or visit www.vitakem.com.
About Vitakem Nutraceutical, Inc.
Vitakem Nutraceutical, Inc., www.vitakem.com, has provided custom manufacturing for the nutrition industry 2003. They provide start-to-finish services that include planning, formulation, production, packaging and labeling, design and order fulfillment. Vitakem's facilities meet current good manufacturing guidelines (cGMPs) established by the U.S. Food and Drug Association (FDA), the World Health Organization (WHO) and the European Union (EU). While Vitakem partners with a range of companies, they specialize in working with small, startup companies. For more information about Vitakem's services or to get a free quote, please visit www.vitakem.com or call 800-233-2112
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Media contact: Bret Hoyt, Sr., Vitakem Nutraceutical, Inc. 800-233-2112 ext. 1
Articles
June - 2010
Vitamin Manufacturers: 3 Key Questions To Ask Your Contract Supplement Manufacturer About GMPs This June
As a small supplement manufacturer, you're probably painfully aware of the new requirements that come into effect for you this June. Small nutritional supplement and vitamin manufacturers, companies with less than 20 employees, have until June 25, 2010 to comply with the FDA's current good manufacturing practices (GMPs).
The 1994 Dietary Supplement and Health Education Act (DSHEA) charged the FDA with establishing and enforcing GMPs. However it wasn't until 2007 that the FDA finally itemized the GMPs that it would require. And in 2008 the FDA began enforcing them with large manufacturers, followed by medium-sized manufacturers in 2009.
Now, it's your turn.
For Small Vitamin Manufacturers, GMPs Bring Benefits As Well As Challenges
While to some extent these regulations may seem onerous, they actually are a boon to an industry challenged by uneven standards and the consumer mistrust that comes with it. For this reason, many companies have welcomed the enforcement of these long overdue regulations. Industry experts predict that the enforcement of GMPs will improve the industry's image and boost the already steady market growth for nutritional supplements.
Nonetheless, making sure you survive this tricky year may require some major changes in your production process. And it certainly means that you need to have a solid manufacturing partner who is ready to help you meet compliance without a hitch.
To make sure you have the right partner, here are three strategic questions to ask them about GMP compliance:
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What has been your history of applying GMPs to your manufacturing process and what are you doing now to insure you're compliant?
Long before the FDA's GMPs went into effect in 2007, many quality manufacturers followed good manufacturing practices borrowed from the pharmaceutical industry, other countries, or established informally within the nutrition industry itself.
It's certainly possible that some companies will be able to establish compliance with limited adherence prior to the establishment of FDA guidelines. But there are clear advantages to working with a partner who has made most of the move already:
A company that has been following GMP guidelines before the FDA enforced them is more likely to have a core commitment to quality. Wouldn't you rather work with a manufacturer who has on its own invested in quality control rather than one forced into it by regulation?
Secondly, having the right equipment is one thing . . . Having personnel experienced in using the equipment is another . . . And having a company culture created by these experienced people - a culture that already focuses on looking for problems, spotting them and attending to them - is even better.
Applying GMPs effectively to manufacturing takes more than just new equipment or even new personnel. It takes a company that has woven good manufacturing into the way it operates. With well-tested systems and experienced people in place, it can meet GMP requirements effectively.
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Do you use any form of internal auditing to catch problems before an outside inspection does?
At one point or other, the supplement manufacturer you're working with will have an FDA inspection of the plant. Hopefully this will go smoothly with maybe a few recommendations, but no major problems.
However, the only way to ensure that there are no disturbing surprises is to be proactive by checking for compliance before the inspector comes. To this end, see if your supplement manufacturer has set up an internal audit system.
With this system, an internal audit team regularly pays surprise visits to various departments and assesses their performance. The team's reports help to initiate discussions, fix problems and improve production procedures. Best of all, this happens before you have an FDA inspector breathing down your neck.
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How will the implementation of these regulations affect my production costs and schedule?
Just about all vitamin manufacturers have had to make some adjustment to meet new regulations. This includes expenses like new equipment, new facilities, or hiring new personnel. And these requirements have also brought new schedules to accommodate new procedures or added steps like raw materials analysis. Both the cost and the scheduling can end up affecting your production costs and schedule.
These new expenses are unavoidable. Some companies will not be able to meet the new costs and will end up closing as a result. The ones that pull through, on the other hand, can look forward to increased consumer confidence that can only boost the nutritional supplement industry's steady growth.
In the short run, a good partner will not only share the increased financial burden with you but will also work with you to look for cost savings. Perhaps it means securing new raw ingredients or scaling up your production to larger runs. Perhaps it means identifying new packaging that will help you save on shipping.
A good supplement manufacturer will help you look for alternatives that can help you continue production in a timely manner without losing a healthy profit margin.
Ask These Questions Of Your Supplement Manufacturer For A Productive Partnership
If you're a small business concerned about meeting these new GMPs, a good supplement manufacturer as a partner can make all the difference. So ask your partner these three questions to gain a deeper insight not only into their ability to meet GMP requirements, but also their commitment to work with you in developing high quality products and a strong business. With this discussion, you can be sure your partnership will be a productive one.
And should you need to find a new contract manufacturer, these questions will also help you find the right one.
To learn more about how we work with small supplement and vitamin manufacturers to help them meet GMP requirements and build a solid business contact our sales team or call us at 1-800-233-2112.
April - 2010
The human body is a complex structure with many processes. For smooth running of these processes, the body needs nutrition. Actually, the medical science suggests certain basic nutritional requirements for a healthy body which, if not fulfilled, lead to diseases. Vitamins, thirteen in number, are needed by human beings to avoid hazardous diseases like night blindness, scurvy, beri-beri and many more.
These vitamins generally come to us through natural food. But the present scenario of chemical fertilizer usage and alike has led to our food items containing less nutritional value. At the same time food is increasingly getting expensive and everyone can't afford to consume enough food to fulfill all the body’s demands.
Now, who do we turn to? Certain vitamin manufacturers like VitaKem have assumed the responsibility of researching and producing vitamin products, that, if taken regularly, can fulfill our body’s demands. Even doctors and health experts are now suggesting that people use vitamin supplements. As consumers are becoming more aware of the deficiencies in their natural diet, they are increasingly utilizing alternative sources for their intake of these nutrients. Due to rising demands, there has been a rapid increase in the number of vitamin manufacturers.
Consumers must also be aware of the possible risks that consumption of vitamin products may cause. It is therefore very important to thoroughly investigate vitamin manufacturers. At a minimum, be sure your manufacturer follows Good Manufacturing Practices, or GMP. GMP is a strict set of rules given by the FDA to the vitamin supplement industry and leads to proper oversight of the manufacturing process and quality control.
Vitakem is a reliable vitamin manufacturer producing vitamin products according to GMP guidelines. Use of our products can help you maintain good health while minimizing risks associated with poorly manufactured products.
In today’s high-tech world, use of modern farming methods has led to a sharp decline in the quality of soil and food production. This has led to our deteriorating health, which we don't realize until it is too late.
While a person may think that he or she has been eating a healthy diet, it may be lacking in many nutritional elements. It is nearly impossible to have the exact amount of each type of nutrient required by our bodies for optimal health. Every food item has different nutrients, and for fulfilling all of our body’s requirements we would have to consume all types of food on a daily basis, which is close to an impossible task. So, we in all likelihood lack something or other in our diet which leaves us prone to diseases. Vitamin manufacturers like VitaKem can solve this problem.
They have realized the need for additional sources of nutrients and produce nutritional supplements that can improve our health, by fulfilling the body’s nutrient demands. These supplements, which are recommended by many doctors, are extremely useful for our health. They compensate for our nutrient deficiencies and help us live a healthy life.
The industry manufactures these products only after conducting extensive research. Reputable manufacturers abide by the guidelines established by Good Manufacturing Practices (GMP). By making sure that your manufacturer follows these GMP guidelines, like VitaKem does, you can be assured of the product’s quality and safety.
Good health can’t be guaranteed, we can give ourselves the best chance of achieving and maintaining it.
March - 2010
Change is the only permanent thing in this world. Everything changes with the changing times. Nothing on this earth remains the same as it was ages ago. We also need to change. As stated, that which doesn't change ultimately dies and we can't let this happen to us. Our food items have also met massive changes in their nutrient value. Rarely does any food item contain the same nutrition value today as it did in the earlier days.
With the fact known to us, comes the need of a vitamin manufacturer. And this need has brought a great upsurge in the manufacturers researching over these nutrient products. In fact, the industry has experienced significant growth in the last decade and is expected to grow further in future times. People are getting more and more educated about these products and their benefits brought to them. Our body needs vitamins for the proper functioning of its processes.
Now, due to large number of companies dealing in vitamin products, there are similarly large number of capsules and powder. Getting the right one for you will be the most significant task in hand when checking out for the best product. Also their easy availability has made it very difficult to get the right person helping you out with the required information.
There are different types of vitamin products produced from the manufacturing industry and these vary in their forms too. Where multivitamins are with multiple vitamins in a one capsule, the single vitamin capsules have just a single vitamin in one capsule. With such difference, there is an obvious reason for the people to prefer multivitamin products rather than single vitamin products. The former can bring benefits of several vitamins in just a single dose.
Another point to mark when making the choice of your vitamin capsule is the brand. You should check out for the product to have passed through the tests for Good Manufacturing Practices. Only after this check should you buy the product for yourself.
Remember that your health is your most previous wealth. Getting the right product of the right vitamin manufacturer is necessary for your healthy body. Vitakem Nutraceutical, Inc., a top ranked Nutraceutical Supplement and Vitamin manufacturer specialist, brings to the table innovation and premium quality in Nutritional Supplements and Vitamin Products.
Man is a restless being and that is the secret of his success. Never has he been satisfied with what he has and it is the primary reason why he has left all other beings way behind. His innovative brain has always been able to extract gems from the deepest oceans. He has brought the best possible solutions for every problem and researches still continue for those that have not been solved. One of the major problems of the recent times has been our health and the vitamin manufacturers have found, and are still working to bring the best possible solution for deteriorating human health conditions.
Being an evolving field, researches in the bio-nutrients field is a continuous process like other fields. Production processes and research processes are also to continuously get better with time. The need of the products of vitamin manufacturers was found with their reducing presence in natural sources. Also that man started lacking even time to eat food leading to his deteriorating health condition.
With the progress of researches in the field, we are to concentrate more on the prevention of diseases than on their cure. The vitamin manufacturers try to focus more on the fact that their products should be able to help people live not only for longer periods of time but also with superior health conditions. They just fill in the gaps arising due to poor eating habits of the people combined with the poor nutrition value of the natural food items.
Also that the world population is on the rise and food outputs from all over the world are not sufficient to suffice the nutrient requirement of each one of us. There is a need of something extra and that extra have been provided by these vitamin manufacturers. Moreover, an aged man demands more of nutrients and researches show that their population is to double by 2020.
Against the advantages of vitamin products, people fear side effects caused by them. They don't realize the effort of the researchers who make a product only after years of researches for the positive effects and assure the least negative impact, if any. With the combination of chemical elements and natural elements, the manufacturers try to produce the best that can assure truly healthy future for the humans.
Bio-pharmaceutical researches have demonstrated great unending futures of the vitamin manufacturing industry.
These products from vitamin manufacturers are true gifts for the mankind!
February - 2010
Body building supplements - To feed your worked-out muscles!
Summary: When you start to use your muscles more, it also starts demanding more. If you find that your usual intake of nutrients is not enough to feed the worked out muscles, you should immediately boost your nutrient intake with body building supplements.
Body building supplements of different types are available in the market. Deciding a good one for your body is a tough task as you need to know all pluses and minuses of each supplement. Also, it is solely dependent on the way your body will react towards the supplements and different bodies have different reaction for any product. It is always suggested that one should try to feed his or her body with some natural food but it is increasingly getting difficult to do so. On the other hand, the rising number of vitamin manufacturer has made it a bit easier to feed enough for a good body.
Anyways, when you have decided to go after the supplements for getting a well built body, you should keep a few dos and don'ts in your mind. It may be harmful, otherwise.
Starting with professional bodybuilding supplements is never suggested for an out of shape body. It could cause more harm to your body than good. It could really put you off and bring suffering moments. The reason for this can be stated that while a gradual and slow change can be adapted by your body, a sudden change will be detrimental.
Before that you should do a good amount of research talking to your seniors, friends and others who could be helpful. Nowadays, a lot of information is available over the internet and these should also be read well to know all about the tablets. After all, it is not the shape of the supplement produced but the constituents in it that really matters.
Bodybuilding is all about strengthening muscles and increasing their weights in the body that matters, so one should mainly go for trying protein based supplements as they are the primary nutrients that help in building muscles.
Once you start taking these supplements, you should never ever stop as that would be very bad for the appearance of your physique. It would cause the muscles to get loose and hang out of the earlier perfect shaped body.
Another thing that you should understand is that there is no supplement complete in itself. And it is very much dependent on the way you work in gym that you will become a Schwarzenegger kind or not.
Now, you should know the tip for buying these supplements at some cheaper price. As you have to keep up with them for a long time, you should get them as bulk purchase such that you can enjoy some kind of discount. This will be savings for you and can again be used for your gym. After all, body building is not a day's task and requires a good amount of zeal and money.
According to the original myths, natural herbs have been working as the solutions for various diseases and human problems. These herbal medicines have traveled a long way since their ancient origins. They are on to further researches to improve their existing products and bring newer ones for the people.
Many companies have also plunged into the herbal world of medicines to help the people. These companies also include the vitamin manufacturers making vitamin products for the men, women and children. The vitamin pills and powder, produced by them, helps you to cope with different deficiencies that appear due to abnormal eating habits.
Whilst the pills are known to be composed of chemicals and have side effects, the herbal medicines are assured of zero side effects. They have been coming down for ages into the human civilization and are also known by the modern medical science to be well effective on all diseases. The earliest account of herbal treatments has its origin in China and dates back to 2800 B.C. Since then they were a part of debated topics and had a rather checkered development.
Actually herbs are valuable sources of natural medicines and have proved to be highly effective on all forms of diseases. Going by the statistics, WHO has approximated that there are around 4 billion people all over the world, or eighty percent of world population are presently using herbal products for health benefits.
If we look through the treatment process in herbal science, they are quite simple and smooth. Falling under the category of complementary and alternative medicines, the herbal products are made through practices very different from the usual allopathic medicines. None of the practices finds any use of even a single chemical product. This makes the medicines even more significant for the people.
Although herbs and plants have great nutritive value and are considered safe for our body, care needs to be taken with their usage and dosage. You know the saying - "Excess of anything is bad". It works here too. You can't have an intake of any herbal medicine in excess quantity. It could prove detrimental for your health.
Presently, seekers of the herbal products are growing in number and thus are rising, the number of vitamin manufacturers picking this part as their enlisted products.
At Vitakem.com - Our herbal vitamin manufacturer services are ideally designed to develop your homeopathic product line. At Vitakem, our professionals innovate and help you build a comprehensive selection of homeopathic supplies through our uniquely comprehensive and pro herbal vitamin manufacturer solutions.
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