Ingredient Review

With a few notable exceptions, all ingredients in foods, drugs, cosmetics, and dietary supplements are required to be listed on the labels of those products.  The requirements are similar, but different for each type of product.

Let R. FLORA & ASSOCIATES, INC. help you determine the regulatory status of the ingredients in your product as well as how they are to be listed on your labels.

Labels and Labeling

The Food and Drug Administration (FDA) has very detailed regulations regarding the labeling of drugs. If your label is not in compliance with those regulations, then your product is misbranded and can be subject to regulatory action such as recall and civil and/or criminal penalties.

We know the regulations.  Review and/or preparation of label copy is the lion's share of our business.  We can review what your have and/or we can help you with all or any part of your label preparation.

GMP Issues

The manufacture, processing, packaging, and holding of drugs must comply with current good manufacturing practice (cGMP) regulations issued by FDA. cGMP regulations cover issues such as sanitation and pest control; education, training, supervision, and sanitary practices of personnel; design, construction, and maintenance of equipment, buildings, and facilities; production and process controls and procedures; quality control and record keeping requirements.

Why not benefit from our considerable experience and contacts?  Let R. FLORA & ASSOCIATES, INC. help you navigate these sometimes difficult regulations.

Drug Listing and Establishment Registration

State Licensing

Import Issues

Food, drug, cosmetic, and dietary supplement products that are imported into the U.S. are required to comply with all the laws and regulations applicable to domestic products. An article will be refused admission if it appears from an examination of the sample, or from any other information, that the article has been manufactured, processed, or packed under insanitary conditions, that sale of the article is forbidden or restricted in the country in which it was produced or from which it was exported, or that the article is adulterated, misbranded, or in violation of new drug requirements.

We can help you determine if your product is in compliance before you bring it in to save you the costs and delays involved with having your product detained or refused.  If your product is detained we can help you navigate the tortuous path of getting it released, reworked and released, returned, or if all else fails, destroyed.  Detention is never a good thing.

Let R. FLORA & ASSOCIATES, INC. put its considerable resources to work for you!

Export Issues

A food, drug, cosmetic, or dietary supplement that is intended for export to a foreign country will not be regarded as adulterated or misbranded under circumstances that assure that the article will not be sold in violation of law. The article must be in accord with the specifications of the foreign purchaser; there must be no conflict with the laws of the country to which it is intended to be exported; the label on the outside of the shipping package must indicate that the article is intended for export; and the article may not be sold or offered for sale in domestic commerce. When a product is seized because of alleged misbranding or adulteration, it is the burden of the claimant to prove that the export exemption applies, because the exemption constitutes an affirmative defense to the charge. 

A drug or biological product that has been approved as safe and effective in specified developed nations may be exported to any country, regardless of whether the product has been approved by the FDA for marketing in the U.S. Exported products must comply with the laws of the country to which they are exported and must be exported pursuant to a valid marketing authorization from that country. Products intended for investigational use in any listed country may be exported to that country without meeting the requirements for investigational use exemptions under the Federal Food, Drug, and Cosmetic Act. A product intended for formulation, filling, packaging, labeling, or further processing in anticipation of approval in a listed country may be exported for use in accordance with the laws of that country. If the FDA has disapproved an application for a drug or biological product, the agency must notify the appropriate official of the country to which the product will be exported that the product was disapproved. 

Products that have not been approved by the FDA or any country listed as having an adequate regulatory system for drugs and biologics may be exported directly to a country that although not listed, meets the regulatory criteria required of listed countries. These include review by a government entity that authorizes the approval of only those products found to be safe and effective on the basis of adequate and well-controlled scientific studies; statutory or regulatory requirements governing the methods, facilities, and controls for the manufacture, processing, and packaging of the products that are adequate to preserve their identity, quality, purity, and strength; requirements for the reporting of adverse experiences and the withdrawal of unsafe products; and requirements that the labeling and promotion of products conform with their approval. 

Exports to countries that are not listed and that do not meet the specified regulatory requirements require a petition to the FDA and the agency's permission to export the product. Permission will be granted only upon a showing by the exporter that the product would meet the requirements for approval by the FDA or by a listed country. The exporter must also provide credible scientific evidence that the product would be safe and effective under the conditions of use in the country to which it is being exported. The appropriate health authority of the country must request the approval of the product's export and concur that the scientific evidence provided by the exporter provides credible evidence of the product's safety and efficacy in that country. The authority must certify that they understand that the product is not approved by the FDA or any listed country. The FDA must act on the petition within 60 days. 

An exporter may request the FDA to certify in writing that a drug or biological product either meets the requirements for FDA approval or meets the requirements for the export of unapproved products. If written certification is issued within 20 days of the request, the FDA can charge a fee of up to $175 for each certificate. The funds collected are to be available only for the costs of the FDA 

Persons requesting an export certificate have the burden and responsibility to provide information that will assist FDA in determining whether a certificate may be issued. Certificates for human drugs, biologics, animal drugs, and medical devices that may be legally marketed, sold, offered for sale, or distributed in the United States should be entitled, "Certificate to Foreign Government", unless required to bear a different name. Certificates for human drug products, including human biological drugs, that conform to the World Health Organization’s certification requirements should be entitled "Certificate of a Pharmaceutical Product". Certificates for products that may not be marketed, distributed, or sold in the United States, but which may be legally exported, should be entitled, "Certificate of Exportability". The appropriate center compliance director or his/her designee may issue certificates. If authentication of the certificate is required, the certificate may be notarized or certified under seal of the Department of Health and Human Services in accordance with 21 CFR 5.22, or both.