Shelley's Place

Nutraceuticals

Functional Foods

US Manufacturing Dietary Supplement Current Good Manufacturing Practices Regulation
FDA Regulations
Health Canada

Quality, safety and trust are necessary in today’s marketplace for companies that want to stay competitive.

FDA Regulations

In the US, finished products, as well as their ingredients, are regulated by the FDA. United States manufacturers and distributors are prohibited from marketing products that are misbranded. They must also ensure that the products are safe and follow FDA good manufacturing practices (GMP). The products and their ingredients must be traceable from seed to end consumer and up to 2 years beyond expiration.

Health CanadaIn Canada these products are managed by Health Canada under NHPID – Natural Health Products Ingredients Database.

The Natural Health Products Ingredients Database (NHPID) provides an electronic tool which enables members of the public to access information on the following topics:

  • acceptable medicinal and non-medicinal ingredients used in Natural Health Products (NHP)

  • standard terminology used by the Natural Health Products Online System (NHP Online System), known as “Controlled Vocabulary”, referring to acceptable quality test methods, dosage forms, non-medicinal ingredient purposes, and so on.

  • pre-cleared information such as single ingredient monographs, product monographs and abbreviated labeling standards (AbLS)

Any violations in manufacturing, labeling or misrepresentation can lead to an FDA inspection or a Health Canada NPN removal.

VIOLATIONS

These violations can be broad ranging and encompass beyond just the labels on the product. Even errors that are seemingly insignificant can have potentially lethal consequences. Which can lead to product recalls and millions in lost revenue, as well as ruin a company’s reputation.

Why Shelley’s Place?

ShelleyRae has managed the licensing of 17 nutraceutical products with Health Canada; from researching, gathering and creation of supporting documents to the creation of the submission itself and input of the required information into the Health Canada submission.

ShelleyRae’s web design and development knowledge has allowed her clients to not be required to maintain multiple sites for compliance. One site, a single point of online presence, meets all FDA and Health Canada requirements.

ShelleyRae can help you keep your business running and strong.

Is your company being hit by natural product contamination issues? Is your brand damaged?

Missing a recall protocol?

Are you simply worried your business will get caught in the mess?

Consultations are FREE

Shelleyrae guides companies to remain in the compliance lane. From purchase, manufacture, testing to distribution with ShelleyRae supporting your business your risks are lower.

Her experience with documentation and creation of protocols has lead to minimizing her clients greatest risks – human injury and recall. Call today for your free consultation 732-Shelley

Wishlist 0
Open Wishlist Page Continue Shopping
×
×

Cart