Premier Quality with Premier Service

  • Phytoforensic Screened for Adulterants
  • Purity Verified
  • Identity Authenticated
  • Composition Confirmed
  • Inorganic Materials Inspected
  • Heavy Metals Examined
  • Moisture Content Analyzed
  • Manufactured to avoid magnesium stearate and other undesirable excipients
  • FREE Design*
  • FREE Labels*
  • FREE Label Printing*
  • FREE Certificate of Analysis
  • FREE Shipping
  • NO MRP (manufacturing retail pricing)
  • NO Hidden Costs*
  • NO Set-Up Fees*
  • NO Recurring or Hidden Costs*
* Restrictions May Apply

FDA FACTS PRIVATE LABELERS NEED TO KNOW

YOU ARE RESPONSIBLE for the distribution of the products being marketed under your firm’s name (i.e., labels)

YOU ARE RESPONSIBLE for the manufacturing and quality control operations of your contract manufacturer. Read below

Who is the FDA?

The U S. Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency that oversees cosmetics, dietary supplements, drugs, medical devices, foods, tobacco, etc. The agency ensures that the products in the market place are safe.

The FDA established regulations to require “current Good Manufacturing Practices (cGMPs)” for dietary supplements.

The cGMP final rule requires that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards..

US FDA made effective 21 CFR Part 111 cGMPs for Dietary Supplements in 2007.

Just as important, 21 CFR Part 111 indicates that the name of the company on the dietary supplement label is responsible for the product content as well as the product supply chain, from raw materials to finished product.

Because manufacturers set their own standards, the same product from different manufacturers may not be equivalent in composition, strength, or bioavailability. Manufacturers are not required to confirm the identity of all ingredients supplied to them, and following cGMP guidelines does not guarantee the absence of all contamination.

FDA requires companies that manufacture, package, label, or hold dietary supplements to comply with the cGMPs.

Code of Federal Regulations (CFR) Part 111
21 CFR 111.453

You must establish and follow written procedures for holding and distributing operations..

21 CFR 111.455
(a) You must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected.
(b) You must hold packaging and labels under appropriate conditions so that the packaging and labels are not adversely affected.
(c) You must hold components, dietary supplements, packaging, and labels under conditions that do not lead to the mixup, contamination, or deterioration of components, dietary supplements, packaging, and labels.
21 CFR 111.460
(a) You must identify and hold in-process material under conditions that protect against mixup, contamination, and deterioration.
(b) You must hold in-process material under appropriate conditions of temperature, humidity, and light.
21 CFR 111.465
(a) You must hold reserve samples of dietary supplements in a manner that protects against contamination and deterioration. This includes:
(1) Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions; and
(2) Using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container- closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which you distribute the dietary supplement for packaging and labeling elsewhere.
(b) You must retain reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations.
21 CFR 111.470

You must distribute dietary supplements under conditions that will protect the dietary supplements against contamination and deterioration.

21 CFR 111.475
Subpart M
(a) You must make and keep records required under this subpart M in accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for holding and distributing operations; and (2) Records of product distribution.

HOW CAN You BENEFIT FROM PRIVATE LABELING WITH PRL?

Free services

  • Free design transfer with existing designs. Custom label services are available for additional fees.*
  • Free labels (basic package, but advanced services available)*
  • Free label printing (basic package, but advanced services available)*
  • Free FDA compliant content for each product via legal review, which includes the content on the manufactured label without a Premier Research Labs reference.*
  • Free Certificate of Analysis*
  • Free shipping fees within the continental U.S.*

Build your own personal brand

  • Grow customers 6x faster - PLMA 2010 Private Label Yearbook
  • Retain up to 7% of your customers - Ipsos-MORU Nationwide Study 2009
  • Brand recognition and loyalty
  • Increase repeat sales
  • Avoid Pricing Wars

Grow sales and margins

  • No fees with basic package*
  • No-cost design*
  • Low minimum orders*
  • Set your own retail price*
  • No retail price restrictions*
  • No recurring or hidden costs will be accumulated*

Access to resources

  • Certificate of analysis provided with every order
  • cGMP compliant facilities
  • Unique delivery systems
  • Patented nutritional ingredients
  • Marketing support
  • Strong technical support

Why Trust Is Important

In 2011, 73% of supplement manufacturers inspected by the FDA failed to adhere to 1 or more regulations.

4. US Government Accountability Office. Dietary Supplements—FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products. Washington, DC: US Government Accountability Office; 2013. pp. 13–244

YOUR VERY OWN PERSONALIZED BRAND IS ONLY 3 STEPS AWAY!

  • 1. Consult with our PRL qualified sales account executive and select your products.
  • 2. Design or provide a label and select from a list of appropriate structure/function claims.
  • 3. Place your order.

BECOMING A PRIVATE LABEL CUSTOMER

We partner with healthcare practitioners, including chiropractors, naturopaths, physical therapists, nutritionists and more. You will be assigned a PRL Account Executive that is a trained health professional to help answer your questions and provide you with confidence in recommending your brand of supplements.

WHERE TRUST IS EARNED

USP Certified

Premier Research Labs™ (PRL) is a licensed primary manufacturer of dietary supplements under 21CFR111 of the FDA and is cGMP certified by the prestigious USP (United States Pharmacopeia) Quality Systems GMP Audited Verification Program.

PRL will be solely responsible for obtaining and maintaining compliance with cGMP(s) and any Regulatory Approvals relating to PRL’s manufacture, clinical testing, distribution, claims and suggested use of nutritional products.

Quality Guaranteed

  • Phytoforensic screened for adulterants
  • Purity verified
  • Identity authenticated
  • Composition confirmed
  • Inorganic materials inspected
  • Heavy metals examined
  • Pathogen microbiology performed
  • Moisture content analyzed
  • Manufactured to avoid magnesium stearate and other undesirable excipients
  • … and more

STRUCTURE / FUNCTION CLAIMS

Structure/function claims explain the role of a nutrient or dietary ingredient intended to affect the normal structure or function in humans, the general well-being from consumption, or describe the means by which a nutrient or dietary ingredient maintains the stated structure or function.

You will have the responsibility for the name of your private labeled product and its trademark, trademark registration and any claims and/or costs associated with it. In addition, you will solely be responsible for all written content, and printed matter pertaining to the private labeled product.

PRL will have final control over the private labeling of products. You will consult with your Account Executive regarding terms and claims that are FDA compliant for each product. Your label will be reviewed by PRL’s regulatory consulting team to ensure FDA compliance. In the end, according to the FDA, you are responsible for your label.

To make the process of private labeling a smooth and seamless experience, avoid using any terms that might imply a product is intended to cure, treat or prevent any disease or condition.

These terms include verbs about your product’s action and should not include disease terms or physical condition names. It is best to avoid terms such as: Changes • Increases • Decreases • Stops • Up-regulates • Down-regulates • Cures • Treats • Mitigates • Heals • Prevents • Cancer • Cardiovascular disease • Macular degeneration • Diabetes • Hepatitis • Osteoporosis • Arthritis • Autoimmune disorder • Inflammatory / Inflammation

This list is not comprehensive, but should provide you with general guidelines to get started as you consider your marketing needs. Our team will review your private label claims and technical information sheets for regulatory compliance and discuss any changes we deem necessary.

Why Trust Is Important

One study reported that 59% of tested botanical supplements contained plant species not listed on the label; additionally, active ingredient substitution was observed among 83% of companies tested.

46. Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013;11:222–235.[PMC free article] [PubMed]

Purity

83%

of companies tested

activly performed

ingrediant sub-

stitution

Identity

59%

of tested botanical

supplements contained

plant species not-

listed on the label.

LOW MINIMUMS & NO SET UP FEES

We want you to get started selling your own brand quickly, easily and without having to pay a large upfront cost. For human supplements, we offer a low private label minimum of 50 units per product. There are no set up fees associated with any of our basic services. We look forward to bringing your superior nutritional, dietary, and private label supplement manufacturing needs to life in the marketplace.

LABEL OPTIONS

Interested in a private label with your own branding? Add your own logo or provide your own custom artwork! Basic label design and printing is included in the prices for private labeled product. PRL reserves the right to modify any artwork to meet industry guidelines or restrictions. If PRL determines that advanced label design or printing is required, your Account Executive will discuss potential fees for the additional service beyond the basic package (such as an advanced label).

PRODUCTION TIME

As a new customer, your Account Executive will discuss your timing needs with you. Our goal is to deliver your product according to your timeline within the cGMP framework. Once you place your first order and the label approval process is complete, production may take 21-25 business days to complete. Your Account Executive will work with you to stay on track with your order, so you don’t miss any opportunities to help your clients and advance your brand.

FREE SHIPPING!

In order to better support your profit margin, which means more money in your pocket, shipping of your labels is free! Our shipping method is either UPS or FedEx ground depending on the weight of your shipment. If you have a preferred courier, please discuss this with your Account Executive.

PAYMENT

We accept credit cards. With the submission of each Purchase Order to PRL, you will make a 50% down payment for the total costs and charges pertaining to the order prior to initiation of PRL’s manufacturing or labeling of corresponding products.* The balance owed is required prior to shipment of the your products.

Is your trusted partner

PRL provides all private label clients:

  • Comprehensive Quality Management System Training
  • GMP Training
  • Certification of Contract Manufacturer Qualification

PRL is certified by United States Pharmacopeia (USP) in the GMP Audit Only Program. USP’s Good Manufacturing Practices (GMP) audit program covers dietary supplement and dietary ingredient manufacturing facilities. USP’s dietary supplement GMP standards incorporate FDA’s GMP requirements as well as USP additional GMP components. USP’s commitment to protecting public health through standards and related programs spans nearly 200 years.

PRL has been in business since 1998 and is regularly inspected by FDA. Our last 2 audits resulted in no reported observations.