OEM Private Brand (Collagen, Anti ageing, Cosmetics, Joints care, Slimming)

Nizona provides you MADE IN JAPAN products in 'Your Private Brand'. (Functional Foods, Nutraceuticals, Wellness Supplements, Dietary Supplements,Skincare Supplements, Energy Drinks, Cosmetics, Fat burning, Fitness, muscle development, etc.) The development stages are as below :

Nizona Product Lifecycle

Frequently Asked Questions

Item

NIZONA

Customer

Content

Product Concept

Customer interested in launching a completely new beauty product easy to carry, with enjoyable taste, targeted to medium-high income, beauty-conscious consumers of his local market

Feasibility

Based on the customer’s concept, NIZONA evaluates technical feasibility of ingredients and their cost impact for customer approval.

Interim Specification

Based on extensive technical and business experience, NIZONA prepares interim “product specification” for confirmation of customer.

Laboratory Sampling (“LS”)

Upon approval of the above, NIZONA will engage a qualified laboratory in Japan to engage in the initial LS. As a result of this work, we submit laboratory samples to the customer

LS approval

Customer receives and approves the LS prepared by NIZONA. In case required, LS are adjusted for meeting requirements of taste, appearance, consistency, etc.

Product Image design

Our team of designers will prepare the initial product image design to the satisfaction of customer.

Product image approval

Customer receives and approves the initial design prepared by NIZONA. In case required, design is adjusted based on customer’s feedback.

Labeling

We are sensitive about legal and regulatory requirements of your country. Therefore, based on prior experience, we will submit language draft for your local label for your careful confirmation and approval.

Manufacturing

Based on the specifics of the case, NIZONA will appoint the most suitable of its existing Japanese sub-contractors. Manufacturing will be engaged only to factories meeting all the quality and regulatory certification requirements of the customer’s country.

Manufacturing reporting

NIZONA will continuously report on the status of the manufacturing to the customer, establishing a realistic and honest delivery lead-time prior to confirming the order.

Logistics support

NIZONA has the expertise of handling complex import/export operations to provide all necessary support to our customers and their shipping agents for smooth international delivery.

Registration & Regulatory

NIZONA has professional capacity to handle complex documentation and regulatory requirements. Upon requirement of customer, NIZONA will prepare and submit all required documentation regarding product and manufacturing process. Close cooperation with the sub-contract manufacturer is assured in order to complete this step.

Registration & Regulatory (USA)

US FDA requires complex submission of data in order to obtain various import permits, which can only be applied from the exporting country. NIZONA has experience in successfully completing the registration of 3 products in the US FDA via online submissions (FCE/SID, etc.)

Marketing & Promotion

Our expert team of marketing specialists will support customer pertaining the launch of the product, with submission of all required information and data when available for the preparation of marketing materials and brainstorming on marketing strategies and promotion.

1. Is NIZONA manufacturing base located in Japan?
Yes
2. Does NIZONA have own factory?
No. NIZONA has an extensive network of Japan Government licensed sub-contract manufacturers. We select the most suitable sub-contract manufacturer depending on our customers’ needs and particular situation.
3. How does NIZONA support me as per import and product registration documents?
NIZONA has technical capacity in regulatory and legal support for producing the documentation required for each specific case/country. Upon understanding our customers’ needs, we will then select the sub-contract manufacturer which has the required licenses for the country in question in addition to producing all the documents required from NIZONA as an exporter. However, we always note our customers that the ultimate responsibility for imports and local regulations in country of destination is theirs.
4. How does NIZONA address the legal regulations and language differences in cases where various packaging materials must be prepared?
Generally, NIZONA provides the basic text for the label/box as per the knowledge that we've gained with experience. In addition, we offer image design services as extra service for our customers. In any case, if NIZONA makes label designs/language, the customer has to approve them before the labels or packages are printed. As OEM contract manufacturer, NIZONA encourages its customers to carefully evaluate their local labeling/product claims regulations and notes that ultimately, it is the customer’s responsibility to carefully prepare all import procedures, customs, labeling and distribution regulations in his own country.
5. How does an NIZONA address preference as to formulation, presentation (i.e., powder, granules, liquid, etc.) and size, when variations are required?
First, NIZONA needs to know your needs. We break down your needs in basics such as: Use, presentation, brand, esthetiques, components, target consumer audience, marketing concept, etc. (please see OEM Matrix in last page) all within the context of a mutually agreed “price band” and MOQ. We then consult you regarding technical feasibility of the product concept and submit samples for your approval. After the “product development” contents and objectives are set, we will work exclusively within the agreed parameters in order to assure effective use of the customers’ time and resources while maintaining customers duly informed of the product development process, if applicable.
6. How does NIZONA address consumer dietary restrictions, perhaps based on Religious observance (i.e., Islamic, Hindi, etc.), since some ingredients in formulation might have to be changed?
This is addressed via the method outlined above. NIZONA always submits the prospective list of ingredients to clients in advance. The clients are very well aware and particular about any problematic ingredients in the beginning. We always look to avoid these ingredients at the onset. Over time, NIZONA has come to understand which ingredients are difficult due to both regulation and Religion but ultimately, it is the customers who give the final approval to our formulations prior to placing their orders.
7. How about Halal certification?
As OEM manufacturers, we can certify that a specific product contains no trace of unwanted raw materials. Moreover, raw materials from river, lake and ocean sources/animals in addition to non-animal sources such as plants, fruits, flowers, wood roots, etc. do NOT require halal certification1 .In other cases, in general unfortunately Japanese factories are still not widely familiar with Halal certification. In fact, there are very few Halal factories in Japan. Hence, although some ingredients we use are Halal certified, most of our products do not have such certification. Again, in case of need, our subcontractors and we can issue a certified letter assuring the non-existence of unwanted material/s in a specific product upon your request. You will be transparently notified and made aware of the product details and ingredients with a complete specification.
8. Does NIZONA accept small lot size orders for private brand products?
Yes. We understand and support our customers being reasonable during the initial orders. The extent of flexibility will depend however on the specifics of the product and the required packaging.
9. Does NIZONA bear inventory?
No. NIZONA doesn't keep your private brand finished product in inventory. At the level of our subcontractors however, we sometimes maintain an inventory of components, including labels, bottles, boxes, ingredients, etc. to reduce supply lead-time of future orders.
10. How does NIZONA select sub-contract manufacturers?
We have already an extensive network of subcontractors in Japan. This allows us to respond to each customer’s needs exactly depending on their situation, size, market and import regulatory needs of their country. In summary, upon understanding your needs, we can determine which manufacturing line is more suitable for you. Rest assured, GMP/ISO certified factories are common in Japan and the Japan Ministry of Health is one of the strictest controllers of safety and hygiene of healthcare products in the world.
11. What is the relationship between NIZONA and the sub-contract manufacturers?
They are our direct contractors in Japan. Our relationship with them is transparent and we have extensive past relationship with them. Hence, the contractual relationship with the contractors is direct between NIZONA and the factory within Japan.
12. What is the relationship between the customer and the sub-contract manufacturers?
The customer is NIZONA’s buyer. Hence, the contractual relationship of seller and buyer is between the customer and NIZONA. Subcontractor in Japan is a factory engaged by NIZONA for the manufacture of the product for our customer. There is no direct contractual relationship between the buyer and the subcontractor.
13. What is my benefit of working with NIZONA?
The Japanese healthcare segment is clearly divided between the large manufacturers and the small/mid size manufacturers:
  • Large manufacturers are few and usually have their own brands and run their own operations and distributions worldwide and/or in partnership with other major companies. Their international distribution channels are strictly controlled and set. For this reason, these companies are as a principle difficult to reach and would usually not entertain “middle sector” business proposals from outside of Japan.
  • Small/Mid sized manufacturers are hundreds and in many cases they work as sub-contractors of large manufacturers’ brand products. They have excellent manufacturing expertise. However, due to tradition or limited capacity/intention, their business model is in most cases focused exclusively on manufacturing and not in sales/marketing and/or foreign markets. These companies rely heavily on traditions, established practices and relationships and for these and the above reasons, in most cases their business is limited to selling within Japan and hence, difficult to reach and manage from outside of Japan.
          NIZONA sells high quality of Japanese products while taking care of all the challenges described above: We create, develop and sell Japanese products to the world by filling the gap and adding value in the supply chain: We solve the language and communication gap. We solve the regulatory and document drafting gap. We solve the product design concept gap (because we are able to understand foreign customer needs). We consult in marketing aspects of the product. We provide technical support. Finally, in cases where a customer requires the development of several products, he does not need to deal with the administration of handling several factories, which have different requirements simultaneously. For this and many other reasons, NIZONA is not a simple trading company, but a true professional in the industry who provides cost-sensitive added value to our customers.
14. Are your products foods, dietary supplements, medicines or drugs?
In Japanese law, products taken orally are largely classified into drugs and foods.
Our products are mainly under the “food” category legally. Therefore, “dietary supplements”, “supplements”, “nutraceuticals”, etc. are ALL consider legally as “foods”.
For such reason, there is usually no special instruction as per the consumption of these products2 because the ingredients of our products are in many cases, essentially healthy ingredients that are present in general food but that we tend not to eat enough of due to busy or sedentary lifestyles.

In General -

In Japanese law, products taken orally are largely classified into drugs and foods. Dietary supplements including vitamins and foods for specified health use (FOSHUs) are regarded as foods and regulated by the Japan Food Sanitation Act and Health Promotion Act. However, these acts are not as stringent as the Pharmaceutical Affairs Act applied to drugs. When products are governed by law, safety is ensured by law at the same time. This means that dietary supplements have no stringent safety standards compared to drugs.

In Nizona case -

We plan, manufacture, sell and distribute food supplements. Although legally “foods”, our products are made under pharmaceutical standards by pharmaceutical manufacturing lines which follow the standards of the Pharmaceutical Affairs Act.
15. What type of documents can NIZONA provide?
NIZONA is the exporter and seller of the products to customers. As such, NIZONA is able to produce all export-related documents. Regarding manufacturing, all our sub-contractors are GMP-ISO certified. Example documents are below:
  • GMP Certificate
  • ISO Certificate
  • Certificate of registration
  • Health Certificate
  • Free Sale Certificate
  • Certificate of Analysis3
  • Certificate of Origin
  • Product Declaration
  • Product Specifications
  • Product Formulation Sheet
  • Manufacturing flowchart certificate
  • Radiation Certificate
  • Veterinary Certificate4
  • Others upon request
16. Can NIZONA provide the documents with attestation?
Yes5 . We can provide attestation (seal and signature) of documents from the following:
  • From NIZONA as exporter
  • From the subcontractor (factory)
  • From Japanese notary
  • From Japan Ministry of Health
  • From Japan Ministry of Justice
  • From Japan Ministry of Foreign Affairs
  • From your country’s local Embassy/Consulate
17. How about other documents such as Material Safety Data Sheet, Stability Tests, Acceleration Tests, etc.?
NIZONA deals primarily (though not exclusively) with products classified as food or dietary supplements under most countries. Of course, depending on the ingredients contained in the specific product, your country may consider some of them as medicines. Unless strictly necessary, we always try to avoid such classification in order to avoid import customs and regulatory administration red-tape. In order to do so, we have the capacity to modify the products formulations to make them match your country’s regulations as food supplements.
As a consequence, the documents mentioned above are not regularly available because they are mostly related to medicines or are standards for factories which handle dangerous chemicals (such as the MSDS or material safety data sheet), which is not our case . However, in some exceptional cases if required, we can still provide some form of additional tests but that will bring an extra cost.
18. Do you have import permits, or do you handle import procedures?
Not in principle. We are based in Japan and are exporters. We are not importers. Hence, we understand and take care of all procedures related to Japan only. However, of course we will always give you all required support (information, documents, etc.) for you to prepare and obtain all required import permits/licenses/quotas of your country , (You must inform us with enough time in advance for preparing the documents. Restrictions and costs may apply) as long as you advise us beforehand of the requirements applicable to your country. In other words, ultimately, all import procedures in the country where the product is to be imported/sold must be taken care by you. We will always provide the product specifications so that you, based on that information, can carefully check any possible import or distribution requirement of your country, which we strongly suggest to do in advance with the aid of professionals.
19. How do I know whether the product I will import is classified as a food/supplement/cosmetic/drug, etc. and hence be required/waived an import permit?
Please note that classification of products greatly varies between countries (E.g. a product may be considered a “food” in Japan, but a “drug” in XY Country, and viceversa. In other cases, a product may be considered a “food supplement” in Japan, but n XY Country such product type does not exist, etc.) and we cannot represent the classification of any product in any country other than Japan because we are not the importers. Having said that, of course we have experience in multiple countries and are ready to share that experience with you; however, that should not be taken as official customs/regulatory advice and you should always consult with a professional in advance to avoid import issues.
During development and/or in the proper time in advance, we will always provide the product specifications (mainly ingredients), for you to determine carefully the classification of this product in your county. In case any sort of registration is required, you should let us know well in advance so that we can prepare and provide the information/documents which are applicable to us as exporters/manufacturers in as much as possible.
20. How about cosmetics?
Almost the same process explained above for food supplements applies for cosmetics, in terms of the work flow. However, documentation is different mainly because cosmetics are not classified as foods under the law:

a. Cosmetic Products regularly do NOT have CoA: Nutritional facts cannot be measured because the product is not for eating. Specifications including safety and microbial assessments can be provided along with a specification of the product, containing the product’s ingredients CAS number, etc.
b. Cosmetic Products are regularly NOT made by GMP factories. Cosmetic products are NOT made by GMP factories. In Japan, GMP applies only for the manufacturing of medicines, not cosmetics. There are of course cases where a pharmaceutical company also makes cosmetics: In such case, the factory has GMP certificate though even in that case the cosmetic product itself has a very different manufacturing process than that of a medicine. However, whenever a cosmetic product is made by a purely cosmetics company, the GMP certificate will not be available. Rather, we can submit a cosmetics manufacturing certificate.

 

P1: Customer: “I have a marketing concept for a new product!” NIZONA will advise and support based on extensive experience.

 

 

 

 

NIZONA Sales Dept. is the primary point of communication with Customer. Central Dept. and sub-contractor support in aspects related with:

Regulations, legal, technical, packing & manufacturing and finally, logistics.

 

P2: Customer / NIZONA Sales Dept: Initial feasibility is made, with interim assessment of possible costs.

 

P3: NIZONA Central Dept: Once Customer agrees the initial interim cost parameter with Sales, “Development phase” starts:

  • Customized and/or laboratory samples are prepared and sent.
  • Product artwork designs are exchanged.
  • Legal and regulatory aspects are assessed and documents are prepared.

 

[This phase requires payment of a development fee]

 

P4: NIZONA Central Dept / Sub-contractor: This is the final phase where once Customer approves the samples and artwork, price is officially defined and manufacturing begins. Products are shipped to Customer
directly from Japan with support of our logistics department.


1Halal Hub Jakim: http://www.halal.gov.my/ehalal/pdf/FAQ_english.pdf


2However, we always advise our customers that, in their private labels, they include the note that pregnant or nursing women in addition to people of less than 18 y/o and/or persons with any kind of allergy or condition should consult the doctor prior to taking the product.


3As CoA requires a product sample, this document can only after final confirmation of the product. Depending on the case, a larger lot of the product is required to issue the CoA


4Applicable for the US imports. Importer needs to have an Import Permit issued by the US Department of Agriculture. Veterinary Certificate issued by the Japan Animal Quarantine Services. Veterinary Certificate can be issued only before goods leave Japan


5Cost applies. Feasibility will depend in legal requirements of the department in question and documents contents


6Only for specific documents under fixed format pre-established by the MoH. This meaning, not any document can be attested by the MoH; but only specific ones depending on case.


7http://www.safetyvet.com/osha/drugmsds.htm