FAQ


MINIMUMS

 

  • Retail volume requirements are 5,000 units per product.

  • Professional volume requirements are 25 gallons per product.

  • Exceptions to minimum quantities will be permitted at JJ Labs discretion on a case by case basis.


LEAD TIMES

  • The typical lead time for manufacturing is six weeks from JJ Lab's receipt of a PO.

  • For any given PO, however, the lead time may vary as a function of raw material availability, timely receipt of components per the bill of materials for each finished product and other factors that may be beyond JJ Lab's control.

  • R&D lead time is typically four to six weeks until first submission following receipt of detailed Product Development Request (PDR).


R&D Fees

  • JJ Labs charges a fee for product development, including projects where a customer provides a starting point formula and a sample product.
  • New formulations, which require more extensive lab resources and R&D, may incur a higher R&D fee.

  • If the initial order quantity is high, or guaranteed higher minimum orders are submitted, some or all of the R&D fees may be credited against an initial purchase order for the product in question.


FORMULA OWNERSHIP

  • JJ Labs will own the formulas unless the customer submits the formula in writing, to include process instructions.

  • In some cases, customers will have the opportunity to purchase, formulas or acquire formulas at no cost, subject to certain production minimums being achieved.


TESTING

 

  • JJ Labs assists with all aspects of efficacy, stability, safety, packaging fit, regulatory and patent filings, and all other issues relating to the production of the Products.
  • Customers will pay for all outside testing costs, which could include compatibility, RIPT, preservative challenge and ophthalmologic or sunscreen efficacy, as well as assay, process and method validation on any OTC product.

  • JJ Labs will inform customers of the cost of any such third party testing and, if approved, will instruct customers to contract for such testing at the quoted amounts.


  • OTC formulas, including sun protection (SPF) products, are subject to additional testing and oversight under the FDA. Development and production costs associated with these products are significantly higher.

  • The cost of OTC formulas is dependent on the number of "active" ingredients the product includes, which can range from one to five, or more.  

  • JJ Labs uses a number of testing labs to ensure the most competitive pricing on the market.  We work with you to customize product pricing, in some cases including such testing costs into the base pricing, and in other situations allowing customers to pay for testing separately and over time.

OTC


JJ LABS RESPONSIBILTIES

  • Manufacture each batch upon the receipt of raw materials and components.

  • Fill and seal tubes, jars, bottles or airless pumps.

  • Apply labels, assemble additional components and apply security seal.

  • Insert each product in an individual box, packer and/or shipper.


CUSTOMER RESPONSIBILITIES

  • Provide JJ Labs with all components, packaging, boxes, packers and shippers.

  • Pay shipping and transportation costs

  • Ensure that any and all requirements of the FDA and other applicable government bodies relating to claims described in the labeling of the Product have been met.

  • Ensure that all export/import laws and requirements are met

  • Pay any extraordinary cost relating to raw ingredients not normally carried in inventory by the lab.


Component & Packaging Requirements

  • Customers supply JJ Labs with samples of all components and packaging in advance of anticipated production dates to ensure that the tooling and other requirements for filling are both achievable and available at the time of production.

  • Some components - including, for example, certain tube materials - may not be well suited for filling in the lab or for screening offsite.

  • Through the use of samples, JJ Labs will be able to perform test filling on its equipment, which may help to identify potential issues that can be resolved by selecting alternative components or packaging.

  • Customer's failure to provide samples of components and packaging could result in production delays.


OVERRUNS

  • The manufacture of each finished product requires an overrun of up to 10% above the total number of units ordered - customers will factor this overrun into each order.

  • JJ Labs will use the overrun products to perform various product testing and to run out all available finished mixes, provided that the lab has the required packaging to complete the finished products in accordance with each product's bill of materials.


COMPONENT SURPLUS

  • Customers will ensure that for all components, a minimum of 10% surplus is ordered and delivered to JJ Labs to accommodate the overrun allowance.

STORAGE  

  • For each PO submitted by customers, JJ Labs will provide a scheduled production date.

  • JJ Labs will accept delivery of components, raw materials and packaging for a maximum period of three weeks before the scheduled production date.

  • Skids may be held on site prior to or following production, subject to a monthly charge of $25/skid.

  • JJ Labs will determine, in its reasonable discretion, which skids it will accept on site.

  • Customers will confer with a designated representative of the Manufacturer to coordinate and confirm all deliveries and receipts.