Sunday, June 14, 2009

FDA approved pet food

A statement made by a pet food company caught my eye the other day: “FDA Approved” it said – and made me wonder: I wasn’t aware there was such an approval, neither as a requirement nor as an option. But I have been wrong before in my life and so I decided to further investigate the matter. Here is what I found, related to pet food right at the place where people should know best: The Food & Drug Administration or FDA. Here I came to find out that they were confronted with that same issue before I came around. So much indeed that they figured it would be even worth for them to publish and dedicate an entire brochure on the subject matter. Like I said, I only want to address pet food related statements, for the entire article including a link to the publication visit “Is it really FDA approved?” In a narrative it looks like this:

“FDA approved": Maybe you saw the words on a company's Web site or in a commercial promoting a new product or treatment. Some marketers may say their products are "FDA approved," but how can you know for sure?
FDA is responsible for protecting the public health by regulating human and animal drugs, biologics (e.g. vaccines and cellular and gene therapies), medical devices, food and animal feed, cosmetics, and products that emit radiation.
But not all of these products undergo premarket approval—a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA's enforcement efforts focus on products after they are already on the market. This is determined by law.
The following facts can shed light on when the term "FDA approved" is appropriate after such a determination is made by the agency.

FDA does not approve companies.
FDA does not "approve" health care facilities, laboratories, or manufacturers. FDA does inspect product manufacturers to verify that they comply with good manufacturing practices.
Owners and operators of domestic or foreign food, drug, …facilities are required to register with FDA.

FDA approves new drugs and biologics.
New drugs and biologics must be proven safe and effective to FDA's satisfaction before companies can market them. FDA does not develop or test products; FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers.
If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.

FDA approves drugs and additives in food for animals.
FDA is responsible for approving drugs and food additives given to, or used on, over one hundred million pets, plus millions of poultry, cattle, swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)

FDA does not approve pet food, but rather approves the food additives that are used in pet food. FDA has the authority to take action against pet food products that are in violation of the law.

FDA approves color additives used in FDA-regulated products.
This includes those used in food, dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency, and each must be used only in compliance with its approved uses, specifications, and restrictions.
In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.”

Up to here, this is pretty much what the FDA guys have to say related to an approval process. In one word: Negative.

I also think the following statements, though related to human applications, make further clear that the FDA does not have too much of an involvement related to any mysterious food approval:

FDA does not approve medical foods.
A medical food is used for the dietary management of a disease or health condition that requires special nutrient needs. An example of a medical food is a food for use by persons with phenylketonuria, a genetic disorder. A person with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine. A medical food is intended for use under the supervision of a physician.
Medical foods do not have to undergo premarket approval by FDA. But medical food firms must comply with other requirements, such as good manufacturing practices and registration of food facilities. Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and non-misleading.

FDA does not approve infant formula.
FDA does not approve infant formulas before they can be marketed. However, manufacturers of infant formula are subject to FDA's regulatory oversight.
Manufacturers must ensure that infant formula complies with federal nutrient requirements. Manufacturers are required to register with FDA and provide the agency with a notification before marketing a new formula.

FDA does not approve dietary supplements.
Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. Most dietary supplements that contain a new dietary ingredient (a dietary ingredient not marketed in the United States before October 15, 1994) require a notification to FDA 75 days before marketing.
The notification must include the information that was the manufacturer or distributor's basis for concluding that the dietary supplement will reasonably be expected to be safe. After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.

FDA does not approve the food label, including Nutrition Facts.
FDA does not approve individual food labels before food products can be marketed. But FDA regulations require nutrition information to appear on most foods, including dietary supplements. Also, any claims on food products must be truthful and non-misleading, and must comply with any special requirements for the type of claim.
Manufacturers are required to provide the serving size of the food and information about the nutrient content of each serving on the "Nutrition Facts" panel of the food label (or on the "Supplement Facts" panel for dietary supplements.)

FDA does not approve structure-function claims on dietary supplements and other foods.
Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is "calcium builds strong bones”.
Dietary supplement firms that make structure-function claims on labels or in labeling must submit a notification to FDA. This notification must be submitted no later than 30 days after marketing the dietary supplement with the structure/function claim. Additionally, the notification must include the text of the claim, as well as other information, such as the name and address of the notifier. FDA does not require conventional food manufacturers to notify FDA about their structure-function claims.
Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease. Conventional foods are not required to carry such a disclaimer.”

This lets me conclude that they don’t approve any animal prescription food, puppy or kitten food or dietary supplements for pets either.

Therefore my advice to you is this: The next time you see any pet food manufacturer making such a claim, think again. They may have some marketing gurus who are in a very bold fashion testing how long they can cash in on not better knowing consumers before they get caught. They also may be extremely profit driven and simply greedy if they are willing to take such a risk. But what risk am I talking about? The FDA states on this very same page only that “Misuse of FDA's logo may violate federal law. FDA's logo should not be used to misrepresent the agency nor to suggest that FDA endorses any private organization, product, or service.” So, it looks to me, making such bold statements doesn’t bear too much of a risk of prison time or heavy penalties.

As usual, it is all up to you, the educated consumer, to make the right decision. The pet owner who is smart enough to look beyond such misleading statements in order to figure out what else may be wrong with the actual product. Manufacturers offering quality products don’t need to rely on distracting the consumer with wrongful information. Their product, even in an overcrowded market as the pet food playing field, speaks for itself.


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