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 food. 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 you 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 food must comply with current good manufacturing practice (cGMP) regulations issued by FDA. cGMP regulations generally 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; and production and process controls. For certain products, the regulations include requirements for record keeping to ensure efficient recall of foods that are found to be contaminated.

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

Bioterrorism Act Requirements

FDA Food Safety Modernization Act Requirements

The FDA Food Safety Modernization Act (FSMA) (P.L. 111-353), enacted on January 4, 2011, implements some of the most significant changes to food safety regulation in 70 years. The FSMA represents a major reform of the food safety provisions of the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and expands the powers of the Food and Drug Administration (FDA) with respect to food. The new law generally does not apply to meat, poultry, or egg products regulated by the U.S. Department of Agriculture.

State Licensing

Many states have licensing requirements for manufacturing, processing, packing, and/or holding foods.  It can be difficult finding and complying with these requirements.

Let R. FLORA & ASSOCIATES, INC. help you with your licensing needs.

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

Foods that comply with U.S. law may be exported to foreign countries if they comply with the laws of those countries. There are also circumstances were foods that cannot be legally distributed in the U.S. may be exported to a foreign country.

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.

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 food products (including dietary supplements) and cosmetics are generally entitled "Certificates of Free Sale". 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.