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What Is GMP Contract Manufacturing?

GMP Contract Manufacturing Services

You may have asked yourself what GMP supplement manufacturing is all about and why it is so important to work with one. What is GMP contract manufacturing, and other queries might be still running through your mind.  First, you need to know what GMP or what Good Manufacturing Practice Regulations are all about and that basically is there to ensure that companies maintain a strict code of ethics as well as quality in the products that they make.

What Do The Regulations State?

Having the backing of the law, these regulations require manufacturers as well as processors and even packagers of drugs, food, medical devices and blood to take the right steps to make sure that the products they put out into the market are not only effective but safe as well. This gives one a broad and general answer as to what is GMP supplement contract manufacturing, cGMP contract manufacturing are, along with what they need to do to make sure that they get on board with these guidelines. These regulations actually make this industry a better place as it is just too sensitive to not have these rules.What is Supplement cGMP Contract Manufacturing

Why Are GMP Supplement Regulations Necessary?

These GMP regulations ensure that when you are looking for a vitamin and supplement manufacturer you are approaching a company with the highest quality supplements and can answer these three queries of what is GMP contract manufacturing, cGMP contract manufacturing, and GMP contract supplement manufacturers. This will mean that companies are more capable of eliminating or even minimizing a certain acceptable degree of errors, mix-ups or even contamination. This will also mean that the consumer gets a product that is not dangerous or one that won’t be effective as far as his needs are concerned.

Consequences of Failure

Companies that do not conform to these rules are liable to certain penalties as laid down by the law. These penalties are what keeps them in check and without them, there is not even thinking what might have been going on. They help keep the right order of things, and mistakes are less or in some cases, even not there at all. Seizure of the company, recall, fines imposed on the company and even some serious jail time are some of the strongest consequences that have been put in place to ensure that the consumer is protected against negligence or inefficiency.

The “c” in cGMP

Well if you look at this phrase what is GMP contract manufacturing, cGMP contract manufacturing or GMP contract manufacturers you will notice the c. This actually stands for the word current, which refers to the fact that manufacturers have to employ the latest systems and technology in order for them to be considered compliant with the regulation. By today’s current technology pace, systems as well as equipment that may have been used fifteen years ago to ensure prevention of errors, mix-ups or contamination may not be relevant at all today. So, companies must always aim to make sure that they comply with these at all times.

GMP Supplement Manufacturer USA

FTC Standard For Made In USA

What Does The Term “Made In USA” Really Mean?

The Federal Trade Commission (FTC) regulates product claims and benefits in the United States., including any U.S. origin claim such as “Made In USA” that may be used on product advertising or labeling.  As such, any U.S. origin claim must be truthful and substantiated.  Here is a short list of some of the definitions and factors that the FTC has outlined regarding such claims.  As a USA health supplement manufacturer, Matsun Nutrition adheres to these strict requirements.

FTC’s Standard for “Made in USA” Claims

What is the FTC Standard for Made In USA?  In order to make an unqualified U.S. origin claim, the FTC has long held that an advertiser must “possess and rely upon a reasonable basis that the product is all or virtually all made in the United States.”1  The “all or virtually all” standard for unqualified U.S. origin claims has three essential requirements:

(1) the last substantial transformation must have taken place in the United States;

(2) the final assembly or processing, except for de minimis finishing, must have taken place in the United States; and

(3) the amount of foreign content must be negligible or non-existent.

Substantial Transformation

“Substantial transformation” is a term used by the U.S. Customs and Border Protection (CBP) to determine the country of origin. Under the Tariff Act of 1930, imported goods, including dietary supplements, must be marked with a foreign country of origin (e.g., “Made in China”).4 When an imported product contains components or ingredients from more than one country, the country of origin is determined to be the country where the last “substantial transformation” took place. Substantial transformation is defined as a “manufacturing process that results in a new and different product with a new name, character, and use that is different from that which existed before the change.”5 Matsun Nutrition may combine raw ingredients from U.S. and foreign suppliers in their manufacturing process.  This process results in a completely new and different product than just that of a single ingredient.  As such, all liquid supplement products manufactured by Matsun Nutrition meet the “substantial transformation” requirement.

FTC Standard For Made In USA

Final Assembly or Processing

The FTC has indicated that an unqualified “Made in USA” claim for a product requires that its last assembly or processing (beyond de minimis finishing processes) be completed within the United States.7 For example, the FTC has stated that for a disposable razor, where the blade and other parts are made in the United States, but the final screwdriver assembly takes place abroad, an unqualified “Made in USA” claim would not be appropriate.8 Based on this example, it is likely that the FTC could find an unqualified “Made in USA” claim deceptive where final bottling of a dietary supplement, for example, took place abroad—even where other processing and ingredients are of domestic origin. A qualified claim still could be made regarding the extent of the U.S. content, such as “Finished in [name of country] with U.S. Ingredients.”  Since all of Matsun Nutrition’s liquid supplements are processed and bottled here at our U.S. based manufacturing facility we clearly meet this requirement.

Foreign and Domestic Content

The third prong of the FTC’s “all or virtually all” standard to make an unqualified U.S. origin claim requires that the amount of foreign content must be negligible or non-existent. Important factors in determining the amount of foreign content include the following:

(1) the proportion of the product’s total manufacturing costs that are attributed to U.S. parts/ingredients or processing; and

(2) the remoteness of foreign content from the finished product.

In addition, the FTC has recognized that where a raw material is not indigenous to the United States or available in commercially significant quantities, an unqualified “Made in USA” claim could still be made because “consumers are likely to understand that a ‘Made in USA’ claim on a product that incorporates such materials means that all or virtually all of the product, except for those materials not available here, originated in the United States.”11 For example, the FTC has indicated that this exception may apply to the vanilla beans in vanilla ice cream; thus, a vanilla ice cream product could be marketed with an unqualified “Made in the USA” claim if all or virtually all other components are of U.S. origin.12 But, the FTC also has cautioned that this consideration is not applicable where the imported raw material “constitutes the whole or essence of the finished product (e.g., the rubber in a rubber ball…).”13 Matsun Nutrition meets the above requirements since the vast majority of each product’s total manufacturing costs are attributed to U.S. ingredients and processing.

References
1. Federal Trade Commission, “Enforcement Policy Statement on U.S. Origin Claims,” December 1997, at 63756, 63768, http://www.ftc.gov/os/1997/12/epsmadeusa.htm. In addition to the 50 states and the District of Columbia, the product may be made in U.S. territories or possessions.
2. FTC Bureau of Consumer Protection, “Complying with the Made in USA Standard,” December 1998, http://business.ftc.gov/documents/bus03-complying-made-usa-standard. 
3. FTC, “Enforcement Policy,” at 63769.
4. 19 U.S.C. 1304, “Marking of Imported Articles and Containers,” Washington, DC: Government Printing Office, 2006.
5. FTC Bureau of Consumer Protection, “Complying with the Made in USA Standard,” at 15.
6. FTC Bureau of Consumer Protection, “Complying with the Made in USA Standard,” at 10. (Explains that a treadmill that is made almost entirely of foreign parts, but where those parts underwent significant processing to be last substantially transformed in the United States, could be marketed as “Made in U.S. from Imported Parts”).
7. FTC, “Enforcement Policy,” at 63678.
8. FTC, “Enforcement Policy,” at 63770, n. 120.
9. FTC Bureau of Consumer Protection, “Complying with the Made in USA Standard,” at 7.
10. FTC, “Enforcement Policy,” at 63679.
11. FTC, “Enforcement Policy,” at 63679, n. 117.
12. FTC, “Enforcement Policy,” at 63679, n. 117.
13. FTC, “Enforcement Policy,” at 63679, n. 117.

Supplement vs Beverage–New FDA Guidance

beverage-survey-drink-aisleOn January 14, 2014 the Food and Drug Administration (FDA) released two final reports providing guidance to determine the clear cut line between dietary supplements and beverages. Over the past few years there has been increased marketing in both dietary supplements and food beverages. Most products have been misrepresented due to labeling, marketing and ingredients. According to the FDA the purpose of this guidance is to, “…describe the factors to consider when determining whether a liquid product should be marketed as a dietary supplement or a conventional food”.   Here are the key points/examples on determining what is a dietary supplement and what is a beverage:

  • Labeling and Advertising- FDA considers statements and graphics on any and all marketed items. Supplement companies cannot use words such as “refreshing”,  “rehydrate”, or any words relating to conventional beverages.
  • Product Name- A supplement company can not name its products with conventional food names such as “beverage,” “drink,” “water,” or “soda”. This is also true with beverage companies when they use words such as “dietary” or “supplement”.
  • Product Packaging–Packaging and design of supplemental items can not be designed to resemble conventional food items. The FDA considers “implied” representation when discerning bad marketing practices.
  • Serving size and Recommended doses- The FDA takes into account the practical sizes of supplements and beverages. If a supplement is over a certain size, then it must be labeled as a beverage.
  • Marketing- The FDA understands the ambiguity of marketing tactics so it takes into account all the labeling, packaging and verbiage used in describing products.
  • Composition- The FDA takes into account the ingredients and the proportions of those ingredients to differentiate between supplements and conventional food items. For example, if Coke decided to make a vitamin-cola, and kept the same coke formula, but just added vitamin A, then it still would be considered a beverage, because of the same proprietary ingredients .
  • Directions- Recommendations or directions to use a product as a “thirst quencher” can be considered recommendations or directions to use that product as a beverage, replacing other beverages such as fruit juice, water or soda and thus represent the product as a conventional food.
  • Other representation of product.- Any representation of products must be consistent and representative with a beverages specific category. Examples of alternative representations may include the product description documents when they are to be trademarked and/or patented, and also documents for international trade and sales.

Supplement vs Beverage--New FDA Guidance

Even though lines and specific regulations have been made, the distinctions between supplement and beverage is still a little gray. The FDA has made great progress differentiating between the two.  Hopefully,  in the future manufacturers will be able to work efficiently and productively without the worry of FDA product distinctions.  You can read more about liquid vitamins and supplements on various liquid supplement blogs.

FDA Label Changes for Liquid Vitamins and Supplements

nutrition-facts_0

There are new FDA Label Changes for Liquid Vitamins and Supplements.  Adapting to the new healthier climate in America, the FDA is planning to change how companies present their nutritional facts and labels.  “The food environment has changed and our dietary guidance has changed,” says Michael Taylor, FDA deputy commissioner, “It’s important to keep this updated so what is iconic doesn’t become a relic.”  A relic is correct. The FDA has not changed it’s labeling in the last 20 years, and it has been working almost a decade to implement the new changes its planning.  As I skim down the nutritional information of my drink, it is a jumble of numbers and hard to read words.

One of the main complaints from health experts is the ambiguity of serving sizes and the amount of serving per container. Often times businesses will include more than one serving per serving making the calorie and other nutrient information deceptive.
Taylor also comments that calories will be more prominently labeled. This might be in reaction to America’s obesity rating. As of a study conducted last year by United Nations food and agriculture organization, 31.8% of all americans are diagnosed with obesity. The FDA will also take a closer look on added sugars and proper labeling. Manufacturers are adding non-naturally occurring sugars and syrups, and these ingredients are not taken into account in the total sugars of the product. Also, mislabeling from manufacturers are occurring as they add natural sugars and label their product “Natural”, when no other natural ingredient is contained within that product.

FDA Label Changes for Liquid Vitamins and Supplements

Finalizing this transition is going to be long and lengthy process. It may take another few years for all the changes to be made, and have every single manufacturer comply with these new regulations. Well, whatever the FDA decides to change, America will be watching. A study performed by the Agriculture Department suggests that over half of all Americans, 57% look at nutritional labels. This is 15% increased compared to 42% in 2010.  It should be noted that the dietary supplement industry will remain unaffected by the changes in FDA regulation. The FDA will be focusing on the food and beverage, due to the high volume and gross mislabeling of products.

Here are some other changes submitted to the FDA from health experts.

— Add the percentage of whole wheat to the label. Some manufacturers will label a product “Whole Wheat” when only a small percentage of whole wheat is actually contained.

— Understandable Measurements. Concerns have been raised due to the fact that Americans don’t understand the metric system. Grams are not easily recognized and palpable, so health expert suggest using teaspoons or tablespoon.

—Front labeling. Nutrition experts are pushing for labels in the front so certain ingredients are more easily noticeable.

Sources:
http://www.cdc.gov/obesity/data/adult.html
http://www.dailymail.co.uk/news/article-2545289/FDA-revise-nutrition-facts-label-make-calories-MORE-prominent.html
http://www.usatoday.com/story/money/business/2014/01/23/fda-to-revise-nutrition-facts-label/4799911/

cGMP Certification and Compliance: Science and Nature Meet

cGMP Certification and Compliance Liquid Supplements

Matsun Nutrition is cGMP compliant.  This means that the facility site and methods employed in the production of our herbs have been subject to a thorough quality control investigation and is certified to be in compliance. The cGMP evaluation process covers all aspects of manufacturing, including inspection of the buildings and grounds, the air and water purification systems, the handling and processing of raw herbs, the product manufacturing process, the operation and cleaning of equipment, the training of personnel and quality control testing and documentation.

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Private Labeling Supplements

 

Private Labeling:  (great for new startups, low 12 bottles minimum order)

 

Supplement Contract Manufacturing

 

Contract Manufacturing:  (custom formulations, 800 bottles minimum order)

 

Adherence to guidelines established in the Chinese Pharmacopoeia, formal Manufacturing Instructions, Standard Operating Procedures and Quality Control Protocols ensures that every batch of product is safe and of the highest quality. These standards are the guidelines upon which our manufacturers base each decision, and allow us to have the confidence to say that our product manufacturers are some of the best herbal product manufacturers not only in China but also in the world today.

As U.S.-based manufacturers of herbal products begin to grapple with the implementation of GMPs for the first time (mandatory as of 2010), it is important to note that even when attained, these will only be Dietary Supplement. Matsun Nutrition’s manufacturing partners are internationally GMP compliant for the manufacturing of medicinal grade products. This necessitates a much higher standard of oversight, manufacturing, and quality control than can be attained by similar products produced in the U.S.

Liquid Supplement Contract Manufacturing

What does GMP compliant mean?

GMP means Good Manufacturing Practices and is a mark that can commonly be found alongside NSF registration. This is a term that is used around the world and signifies that product has been tested for quality control. cGMP also regulates the equipment used to create each product and requires that all methods of operation, which includes: cleaning, testing, and manufacturing, have been validated to perform their specific function.

In short, GMP and NSF registration mean that you are getting a safe and consistent product each time that you buy it. With ongoing NSF and GMP processes, the same high standard is applied to the product whether you purchase today or three years later. It will always be the same product manufactured with the same high standards.

Liquid Supplement Manufacturer FDA cGMP Compliance

Matsun Nutrition is in full compliance with all FDA, NSF, and cGMP regulations

Matsun Nutrition is a liquid supplement manufacturer that is fully FDA, NSF registered and cGMP Compliant. We meet all state and federal manufacturing requirements.  The advanced quality control systems at Matsun Nutrition help to make Matsun Nutrition the most advanced liquid vitamin manufacturer in the USA.  We manufacture health supplements for partners worldwide. The quality control and care that goes into each of our supplements far exceed that of the nutraceutical industry and liquid manufacturing industry standards.

As a liquid health supplement manufacturer,  Matsun Nutrition goes above and beyond what is required by the FDA and State Governments to ensure that their products are of the utmost quality. Matsun Nutrition is an NSF registered, cGMP compliant contract manufacturer. Although our qualified technicians are very diligent in their efforts to support the quality goals of Matsun Nutrition, we feel that strict procedures are necessary in order to maintain a consistently excellent liquid vitamin. We invite you visit us in southern California and to tour our facility.   Compare our contract manufacturing systems, processes and procedures to other companies in the industry.  Matsun Nutrition conducts semi-annual Third Party inspections by three separate agencies and organizations as well as periodic internal audits to ensure strict compliance with all quality control policies and cGMP standard operating procedures. Rest assured that you have found the highest quality in liquid supplement manufacturers.

Liquid Supplement Manufacturer FDA cGMP Compliance

Thank you for visiting Matsun Nutrition and we hope you will call us with your questions and order information.  Come to Matsun Nutrition for contract manufacturing liquid vitamins and dietary supplements.  We are more than happy to assign a team to your specific liquid custom supplement needs.   We can also do private labeling!

For more information call (888) 866-5755 or e-mail us: [email protected]

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