Private Label
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
- Label Printing Included*
- Certificate of Analysis (upon request)
- NO MRP (manufacturing retail pricing)
* Restrictions May Apply
How Can You Benefit from Private Labeling with PRL?
Included Services
- Design transfer with existing designs. Custom label services are available for additional fees.*
- Label printing*
- FDA compliant content for each product via legal review, which includes the content on the manufactured label without a Premier Research Labs reference.*
- Certificate of Analysis (upon request)*
Build Your Own Personal Brand
- Grow customers 6x faster
- Retain up to 7% of your customers
- Brand recognition and loyalty
- Increase repeat sales
- Avoid Pricing Wars
Grow Sales and Margins
- Competitive Margins*
- Low minimum orders*
- Set your own retail price*
- No retail price restrictions*
Access to Resources
- Certificate of analysis provided upon request
- cGMP compliant facilities
- Unique delivery systems
- Patented nutritional ingredients
- Marketing support
- Strong technical support
Your Very Own Personalized Brand is Only 3 Steps Away!
1. Consult with our PRL qualified sales team 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.
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.
Low Minimums & 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 100 units per product (50 units on reorders). 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! Printing is included in the prices for private labeled products. 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 sales representative will discuss potential fees for the additional service beyond the basic package (such as an advanced label).
Production Time
As a new customer, your sales representative 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 sales representative 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.
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.
Premier Research Labs 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.
Why Trust is Important
In 2011, 73% of supplement manufacturers inspected by the FDA failed to adhere to 1 or more regulations.*
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.*
Purity
83% of companies tested actively performed ingredient substitution.
Identity
59% of tested botanical supplements contained plant species not listed on the label.
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
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]
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.
