REGULATORY & COMPLIANCE

Regulatory & Compliance
Support To Ensure Your
Private Label’s Success

Regulatory compliance is of paramount importance in the cosmetic and over-the-counter (OTC) industries. These sectors are highly regulated to ensure consumer safety and product efficacy. Here are a few key reasons why regulatory compliance is crucial:

  1. Consumer Safety: Compliance with regulations helps safeguard the health and safety of consumers. Strict adherence to regulations ensures that cosmetic and OTC products undergo thorough testing, ingredient evaluation, and quality control measures, reducing the risk of adverse reactions or harm to consumers.
  2. Product Efficacy: Regulatory requirements often include efficacy testing to validate product claims. Compliance ensures that products deliver the intended benefits, meeting consumer expectations and building trust in the brand.
  3. Legal Obligations: Non-compliance with regulations can result in legal repercussions, including penalties, product recalls, or even business closure. Adhering to regulatory guidelines helps companies avoid legal issues and maintain their reputation.
  4. Industry Standards: Compliance with regulations promotes consistency and uniformity across the cosmetic and OTC industries. It establishes a level playing field, ensuring fair competition and maintaining industry integrity.
  5. Consumer Confidence: Regulatory compliance enhances consumer trust in cosmetic and OTC products. When customers see that a brand complies with regulations, they have greater confidence in the safety and effectiveness of the products they purchase, leading to brand loyalty and repeat business.


Spa De Soleil offers customizable regulatory services to meet client/project needs. From ingredient evaluation to labeling compliance, we provide tailored solutions to navigate the complex regulatory landscape for your cosmetic and OTC products.

MoCRA Compliance

Dear Valued Client:

As you may be aware, Congress passed the Modernization of Cosmetics Regulation Act (MoCRA) in December 2022.  MoCRA substantially changes the regulatory requirements for cosmetic products in the U.S., and it is set to take effect in late 2023.

MoCRA places several new requirements on brand owners of cosmetic products. Below, you can download a table outlining the new requirements created by MoCRA and showing which requirements apply to your company as the brand owner.  The FDA has not yet announced the effective dates for compliance, and we at SDS are still in the process of acquiring all available information and learning about the new requirements. In the meantime, we encourage you to stay informed and reach out to a qualified regulatory compliance specialist who can assist your company with preparing for compliance when the dates are announced by the FDA.

MoCRA also places new requirements on manufacturers of cosmetic products. Spa de Soleil is currently working with our compliance specialists to ensure that we are prepared to transition to the new compliance rules when they are finalized by the FDA.

Once we learn all the necessary information and processes, SDS will open another regulatory service department to assist our clients in this arena. As of now, we do not have details on timing and or fees, but we will update you as soon as we are able.

MoCRA is not projected to take effect until the end of 2023, but we at Spa de Soleil will continue to monitor FDA communications for information and updates.  Please feel free to contact us if you have any questions about the company and brand owner/manufacturer responsibilities and the upcoming changes.

IN-HOUSE, EZ-RUN & SAMPLES SHOPS TERMS AND CONDITIONS AGREEMENT

By placing this order with Spa de Soleil, Inc. (“Developer”), you (“Client”) agree to the following terms and conditions of sale.  Please review carefully and confirm your agreement with your signature below.

  1. All sales are final.
  1. The Developer is not liable for any damages, delays, or losses that occur once goods are handed over to third-party shipping providers. This delineation of responsibility means that the Client assumes the risk associated with the shipping process, including the handling and condition of the goods during transit.
  1. Legal Compliance: Client is solely responsible for ensuring that the products and all products are sold in compliance with application regulations, State and Federal including FDA regulations governing product labeling and claims. Client acknowledges and agrees that Developer shall not be liable for any actions or representations of Client or any third party that causes the products or the sale of the products to violate applicable laws or regulations.
  1. Actions of Third Parties: Client acknowledges and agrees that Developer shall not be liable for any delays, loss, or damage to product or product packaging caused by third parties, including without limitation, shipping providers, fulfillment services, distributors, or retailers. Client further acknowledges and agrees that Developer shall not be responsible for providing or selecting product containers or packaging that meet or exceed durability standards, including without limitation, crush test certifications, required by shipping and fulfillment service providers. Client is solely responsible for determining the suitability and feasibility of all product containers and packaging. SDS is not liable for shipping 3rd party vendors.
  1. Release: Client acknowledges and agrees that it has sole responsibility solely responsible for proofing, approving, and ensuring legal compliance of all product formulations, label designs, label content, or product claims. Client releases Developer from all liability arising from or in connection with any product formulation, required or voluntary product registration, regulatory approval, product labeling, or product claims. Client understands and agrees that in no event shall Developer be liable to Client for any direct, indirect, special or consequential damages or lost profits, related to or arising from or in connection with any product formulations, label designs, label content, or product claims.
  1. Indemnity: Client, to the fullest extent permitted by law, hereby agrees to pay, defend, indemnify and hold Developer, its employees, heirs, successors and assigns harmless from any and all claims, demands, causes of action, damages, losses, costs, expenses, or government regulatory action or inquiry resulting from or arising in connection with product formulations, label designs, label content, or product claims. Client furthermore agrees to carry general liability and product liability insurance with limits of liability of not less than $1,000.00 per incident and no less than $2,000.00 in total liability coverage. Such insurance must cover all products sold under this Agreement and survive for a period of not less than five (5) years from the date of this Agreement.
  1. Limitations of Warranty: Developer warrants that all Product delivered to Client shall be produced according to current good manufacturing practices and shall conform to approved samples. Client understands and acknowledges that there may be variances in viscosity, color, and texture between lab samples and finished production of a given product. Client agrees that such variances are normal and acceptable. Client acknowledges that custom production or custom manufacturing may result in unavoidable overages. If Client orders custom production or custom manufacturing, then Client agrees to accept all such overages which shall be billed to the Client in the final invoice. Developer requires a pre-press sample for custom production if Developer arranges or orders the printing of labels or screen printing on behalf of Client. In order to produce a pre-press sample, Client shall provide a high-resolution file of print-ready artwork. Developer reserves the right to charge fees for a prepress sample and shall provide Client with a quote for such fees upon request. Developer shall provide to Client a Safety Data Sheet (“SDS”) and Certificate of Analysis (“COA”) for each Product after production. Other or additional documentation or regulatory requests shall be quoted separately.
  1. Force Majeure: Neither party shall be in breach of this Agreement or responsible for damages caused by delay or failure to perform in full or in part its obligations hereunder, provided that there is due diligence in attempted performance under the circumstances and that such delay or failure is due to one of the following events of force majeure: fire, earthquake, unusually severe weather, strikes, government sanctioned embargo, flood, act of God, war, act of any public authority or sovereign government, civil disorder, delay or destruction caused by public carrier, or any other circumstance substantially beyond the control of the party to be charged, and which cannot be reasonably forecast or prevented. Each party to this Agreement agrees and understands to notify the other promptly upon discovery of an event of force majeure, as set forth above, which may cause a failure or delay in performance hereunder. Notwithstanding the foregoing, a delay in performance due to an event of force majeure shall be excused only so long as the event continues or until a commercially reasonable alternative method of performance can be implemented. If performance by either party hereunder is delayed more than thirty (30) days due to an event of force majeure, then the other may terminate this Agreement upon thirty (30) days notice, if the event of force majeure has not ceased during such period.
  1. Unpaid Invoices: This agreement is not valid or binding on Developer until payment, including shipping, is made in full per the terms and conditions stated above. In the event that Client fails to make payment to Developer for any outstanding invoices, with a reasonable amount of time, Developer may retain possession of any stock produced by Developer for Client’s account and take reasonable measures to recuperate Developer’s losses by selling any such stock even if product stock is compounded from a finished formula owned by Client or bears Client’s labels, trade names, trademarks, trade dress or other Client intellectual property.
  1. Right of Developer to Sell Off Any Existing Unpaid Inventory: The parties understand that the terms of payment for products included in this Agreement and any separate Agreement for production of products are a material condition of this Agreement. In the event Client does not pay for any products which have been produced by Developer and which products and/or packaging contain and/or are protected by any proprietary intellectual property of Client, including, without limitations, any patents, copyrights, or trademarks, Client hereby grants to the Developer for the sum of one dollar and for other good and valuable consideration, and the receipt and sufficiency of which are hereby acknowledged, the non-exclusive right to sell all remaining inventory in Developer’s possession, which has been produced by Developer for Client and for which Client has not paid pursuant to the terms of the Agreement, and to sell such inventory in any manner whatsoever to any wholesaler or retailer at Developer’s sole discretion. Client hereby grants Developer the non-exclusive license; so that the sale by Developer to recoup all or a portion of the costs or profits which it would have received had Client made the payments will not be considered an infringement of any intellectual property rights owned by Client.  Developer will only sell off the inventory that it has produced, for which it has incurred expenses, and incurred costs, which have not been paid by Client.  Client understands and agrees that if there is excess packaging, Developer can utilize the packaging for its own use with no credit to Client.
  1. All prices are subject to change at any time and in the sole discretion of Developer. Client is informed that prices are subject to change and Developer will alert customers to changes as necessary.
  1. This agreement shall be governed by and construed under the laws of the State of California. Any dispute between Client and Developer arising out of or in connection with this Agreement shall be brought exclusively before the Courts of the State of California.

This agreement constitutes the entire understanding between Client and Developer with respect to the subject matter and supersedes all prior agreements between the parties and any representations or promises made by third parties, whether oral or written. This agreement may be amended or modified only by an instrument in writing, signed by an authorized representative of both parties.

For questions regarding your order or for any notices to be sent pursuant to this Agreement, email Developer at info@spadesoleil.com.

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