FDA Cracks Down on Hills Pet Nutrition

[Britster]

Hill's Pet Nutrition Inc 11/23/11

WARNING LETTER
Ref. KAN 2012-02

Neil Thompson
President and CEO
Hill’s Pet Nutrition, Incorporated
400 SW 8th Street
Topeka, Kansas 66603

Dear Mr. Thompson:

This letter concerns Hill’s Pet Nutrition’s marketing of the Science Diet® Healthy MobilityTM Adult Dry Dog Food (“the Healthy Mobility Diet”)[1]. The Food and Drug Administration (FDA) reviewed the label and labeling of this product, including statements made on your website at the Internet addresses Hill's Pet Nutrition Home | Select a Location and Science Diet: Healthy Pet Food for Cats and Dogs | Hill's Pet Nutrition. Based on claims made by Hill’s Pet Nutrition for this product, the Healthy Mobility Diet is a drug under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (“FD&C Act”), [21 U.S.C. § 321 (g)(1)(B)], as it is intended for use in the mitigation and treatment of joint disease in dogs. As discussed below, this product is an unapproved new animal drug and your marketing of it violates the FD&C Act.

The Healthy Mobility Diet bears the following claims on its label:
“Tested nutrition to enhance active mobility in just 30 days”
“Improves joint flexibility in just 30 days”
“Enhance active mobility in just 30 days
Vital fatty acids
Optimal levels of Omega-3 fatty acids to enhance overall mobility”
“Improve joint flexibility in just 30 days
Omega-3 fatty acids plus Glucosamine & Chondroitin Sulfate
Natural key building blocks of healthy cartilage and joint function”

The product’s label also bears the statement, “For more information about our precisely balanced nutrition and about other Hill’s® Science Diet® pet foods visit www.sciencediet.com.” This link takes a consumer who accesses it to a page on the hillspet.com website: Science Diet: Healthy Pet Food for Cats and Dogs | Hill's Pet Nutrition.

FDA acknowledges that the claims on the Hill’s Healthy Mobility Diet label – “enhance active mobility” and “improves joint flexibility” – appear to be claims that the product affects the structure or function of the body (“structure/function claims”), and the FD&C Act permits foods to make appropriate structure/function claims.

Some structure/function claims, however, imply that the product has an impact on disease. Although a food may make claims that refer to the product’s ability to maintain healthy structure or function, structure/function claims that imply the product is intended to diagnose, cure, mitigate, treat, or prevent disease are classified as “disease claims” and the product for which the claims are made is regulated as a drug.[2] FDA evaluates the context in which a structure/function claim is made to determine whether it is a disease claim. See 21 C.F.R. §101.93(g).[3]

The Hill's Pet Nutrition website provides ample context showing that the Healthy Mobility Diet is intended to treat or mitigate joint disease in dogs. The content on your website implies that the Healthy Mobility Diet has an effect on joint disease, including arthritis, by referring to identifiable characteristics of the disease. Reference to a characteristic set of signs or symptoms of a disease, even in the absence of the name of the disease, can be understood as a reference to the disease. See 21 C.F.R. 101.93(g)(2)(ii). The following lay terminology is used on your website to describe the “early signs of joint health issues”:
“Slow to get up or down”
“Lagging behind while walking”
“Longer recovery time after play or exercise”
“Less playful, running less or less active in general”
These signs are consistent with and indistinguishable from the characteristic signs and symptoms of arthritis, a broad spectrum of joint diseases with numerous etiologies. For instance, a page on your website entitled “Arthritis and Joint Pain” states that “If your dog has arthritis, the first thing you'll notice is that he or she finds movement difficult and is reluctant to walk, run and jump.”

Read more: Hill's Pet Nutrition Inc 11/23/11

[Nancy1999]

I think this is just because Hill's uses the word “arthritis” on it's website, and this is considered a disease and you can’t claim a food or supplement helps with a disease or it will be classified a drug. I think it has more to do with wording and our laws, which can be very confusing.

"Although a food may make claims that refer to the product’s ability to maintain healthy structure or function, structure/function claims that imply the product is intended to diagnose, cure, mitigate, treat, or prevent disease are classified as “disease claims” and the product for which the claims are made is regulated as a drug.[2] FDA evaluates the context in which a structure/function claim is made to determine whether it is a disease claim."

So many suppliments aren't watched by the FDA because they don't actually claim to help with disease on the bottle, but that information is put out elsewhere. It sounds like Hills is adding Glucosamine, Chondroitin, and Omega-3 fatty acids and many of us suppliment with those, so I would think adding it to food could be a good thing.

[tem_sat]

Originally Posted by Nancy1999

It sounds like Hills is adding Glucosamine, Chondroitin, and Omega-3 fatty acids and many of us suppliment with those, so I would think adding it to food could be a good thing.

According to the Adult Healthy Mobility page found here Adult Healthy Mobility? - Dry, it states:

"Enriched with high levels of Omega-3 fatty acids; plus Glucosamine and Chondroitin Sulfate from natural sources - Science Diet® Adult Healthy Mobility™ dog food helps maintain ease of movement and is formulated to support bone and joint cartilage."

To me, I understand that to read that they are not "adding" Glucosamine and Chondroitin, but instead stating that it is coming from natural sources.

The ingredient list shows:
Whole Grain Corn, Whole Grain Wheat, Chicken By-Product Meal, Soybean Meal, Animal Fat (preserved with mixed tocopherols and citric acid), Chicken Liver Flavor, Corn Gluten Meal, Flaxseed, Fish Oil, Dried Beet Pulp, Lactic Acid, Powdered Cellulose, Soybean Oil, Natural Flavor, Potassium Citrate, DL-Methionine, Choline Chloride, L-Lysine, Calcium Carbonate, vitamins (L-Ascorbyl-2-Polyphosphate (source of vitamin C), Vitamin E Supplement, Niacin, Thiamine Mononitrate, Vitamin A Supplement, Calcium Pantothenate, Biotin, Vitamin B12 Supplement, Pyridoxine Hydrochloride, Riboflavin, Folic Acid, Vitamin D3 Supplement), Taurine, Vitamin E Supplement, minerals (Manganese Sulfate, Ferrous Sulfate, Zinc Oxide, Copper Sulfate, Calcium Iodate, Sodium Selenite), Iodized Salt, L-Tryptophan, L-Threonine, preserved with Mixed Tocopherols and Citric Acid, L-Carnitine, Phosphoric acid, Beta-Carotene, Rosemary Extract.

I assume the "natural sources" are the Chicken By-Product Meal?

[Nancy1999]

Originally Posted by tem_sat

According to the Adult Healthy Mobility page found here Adult Healthy Mobility? - Dry, it states:

"Enriched with high levels of Omega-3 fatty acids; plus Glucosamine and Chondroitin Sulfate from natural sources - Science Diet® Adult Healthy Mobility™ dog food helps maintain ease of movement and is formulated to support bone and joint cartilage."

To me, I understand that to read that they are not "adding" Glucosamine and Chondroitin, but instead stating that it is coming from natural sources.

The ingredient list shows:
Whole Grain Corn, Whole Grain Wheat, Chicken By-Product Meal, Soybean Meal, Animal Fat (preserved with mixed tocopherols and citric acid), Chicken Liver Flavor, Corn Gluten Meal, Flaxseed, Fish Oil, Dried Beet Pulp, Lactic Acid, Powdered Cellulose, Soybean Oil, Natural Flavor, Potassium Citrate, DL-Methionine, Choline Chloride, L-Lysine, Calcium Carbonate, vitamins (L-Ascorbyl-2-Polyphosphate (source of vitamin C), Vitamin E Supplement, Niacin, Thiamine Mononitrate, Vitamin A Supplement, Calcium Pantothenate, Biotin, Vitamin B12 Supplement, Pyridoxine Hydrochloride, Riboflavin, Folic Acid, Vitamin D3 Supplement), Taurine, Vitamin E Supplement, minerals (Manganese Sulfate, Ferrous Sulfate, Zinc Oxide, Copper Sulfate, Calcium Iodate, Sodium Selenite), Iodized Salt, L-Tryptophan, L-Threonine, preserved with Mixed Tocopherols and Citric Acid, L-Carnitine, Phosphoric acid, Beta-Carotene, Rosemary Extract.

I assume the "natural sources" are the Chicken By-Product Meal?

I know many people are going to read so much into this, but all you have to do is read the FDA letter, it states:

Some structure/function claims, however, imply that the product has an impact on disease. Although a food may make claims that refer to the product’s ability to maintain healthy structure or function, structure/function claims that imply the product is intended to diagnose, cure, mitigate, treat, or prevent disease are classified as “disease claims” and the product for which the claims are made is regulated as a drug.[2] FDA evaluates the context in which a structure/function claim is made to determine whether it is a disease claim. See 21 C.F.R. §101.93(g).[3]

So it's only because they used the word "arthritis" which is a disease.

[107barney]

Originally Posted by Nancy1999

I know many people are going to read so much into this, but all you have to do is read the FDA letter, it states:

Some structure/function claims, however, imply that the product has an impact on disease. Although a food may make claims that refer to the product’s ability to maintain healthy structure or function, structure/function claims that imply the product is intended to diagnose, cure, mitigate, treat, or prevent disease are classified as “disease claims” and the product for which the claims are made is regulated as a drug.[2] FDA evaluates the context in which a structure/function claim is made to determine whether it is a disease claim. See 21 C.F.R. §101.93(g).[3]

So it's only because they used the word "arthritis" which is a disease.

Exactly Nancy. It really is about reading comprehension.

[Britster]

I'm just posting as an FYI, just as I do for any food recall or FDA warning I see. I have in the past for Champion, Blue Buffalo, etc, etc. I have no opinions on it, lol. I don't think this sounds like a huge deal. But thought it was worth posting!

[Nancy1999]

Originally Posted by Britster

I'm just posting as an FYI, just as I do for any food recall or FDA warning I see. I have in the past for Champion, Blue Buffalo, etc, etc. I have no opinions on it, lol. I don't think this sounds like a huge deal. But thought it was worth posting!

The problem is many people will think it's a huge deal, there will be so many people who interrupt that as Hills is doing something really wrong, and that doesn't appear to be the case. People will see the word "WARNING" and that's about all. It's so sad when people are scared to buy a food because of all the propaganda posted on the Web. I can understand posting a food recall, but it might be best to explain what the FDA warning means.

[Britster]

*shrugs* I posted about a Blue Buffalo warning a while back, not a recall, and many thought it was a pretty big deal. Same thing with Champion and their fish waste. I think it's important to get the information out there for all the pet food companies!

http://www.yorkietalk.com/forums/yor...nned-food.html
http://www.yorkietalk.com/forums/yor...ry-recall.html
http://www.yorkietalk.com/forums/yor...e-buffalo.html
http://www.yorkietalk.com/forums/yor...n-recalls.html

[Nancy1999]

Originally Posted by Britster

*shrugs* I posted about a Blue Buffalo warning a while back, not a recall, and many thought it was a pretty big deal. Same thing with Champion and their fish waste. I think it's important to get the information out there for all the pet food companies!

http://www.yorkietalk.com/forums/yor...nned-food.html
http://www.yorkietalk.com/forums/yor...ry-recall.html
http://www.yorkietalk.com/forums/yor...e-buffalo.html
http://www.yorkietalk.com/forums/yor...n-recalls.html

Didn't read your other posts that I recall, but I don't understand what they have to do with this?

I'm only trying to reassure someone that this warning means very little and don't panic, the food has what it says in it. Hill just can't claim it helps with arthritis or the food will be considered a "drug" not a food.

[Britster]

Originally Posted by Nancy1999

Didn't read your other posts that I recall, but I don't understand what they have to do with this?

I'm only trying to reassure someone that this warning means very little and don't panic, the food has what it says in it. Hill just can't claim it helps with arthritis or the food will be considered a "drug" not a food.

I understand! I just thought it was being implied that I posted this just because it's "Hills", but it's not the case, lol. I find things about different food companies and always like to share because I am a dog food dork like that. And think it's worth sharing. It makes me feel good to know that the FDA takes note of even such little things, it gives me a bit of faith that they are doing a decent job monitoring things!

[Nancy1999]

Originally Posted by Britster

I understand! I just thought it was being implied that I posted this just because it's "Hills", but it's not the case, lol. I find things about different food companies and always like to share because I am a dog food dork like that. And think it's worth sharing. It makes me feel good to know that the FDA takes note of even such little things, it gives me a bit of faith that they are doing a decent job monitoring things!

No, I didn't even remember that Hills was Science Diet, so I didn't imply it. I just think there are way too many scare threads that really have no meaning.

Personally, I wish the FDA could have more teeth in doing things with supplements and "holistic" medications and weight loss drugs and "natural" supplements. These companies get away with murder because they don't promise to help with disease, and aren't considered a "drug." However, they do promise all sorts of other outrageous claims, but there's no regulation because they aren't a drug.

[Ellie May]

Thanks for posting this. Looks like Hill's messed up on their wording and they just need to reword what's on the site and bag. Seems as though they can't say arthritis, but also can't avoid saying it by giving a long list of likely symptoms either.

I'd like to know how all the holistic supplement companies get away with what they do though if Hill's can't word things this way. I guess only because this is food and they don't do supplements at all.

[Nancy1999]

Originally Posted by Ellie May

Thanks for posting this. Looks like Hill's messed up on their wording and they just need to reword what's on the site and bag. Seems as though they can't say arthritis, but also can't avoid saying it by giving a long list of likely symptoms either.

I'd like to know how all the holistic supplement companies get away with what they do though if Hill's can't word things this way. I guess only because this is food and they don't do supplements at all.

They don't claim to help a disease. It seems to me, that many of the websites that claim certain supplements do such and such aren't seemly connected to the manufacturers, it's as if it's independent information, and you buy the supplement elsewhere. This is okay, since the manufacturers aren’t' making the claims. Then, you also have small companies that make outrageous claims, but are out of business and under a new name, before the FDA can do anything about it.

Who has the responsibility for ensuring that a dietary supplement is safe?
By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace. However, manufacturers and distributors of dietary supplements must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. FDA is able to evaluate these reports and any other adverse event information reported directly to us by healthcare providers or consumers to identify early signals that a product may present safety risks to consumers. You can find more information on reporting adverse events associated with the use of dietary supplements at Dietary Supplements - Adverse Event Reporting5.Overview of Dietary Supplements

[Britster]

Originally Posted by Nancy1999

Personally, I wish the FDA could have more teeth in doing things with supplements and "holistic" medications and weight loss drugs and "natural" supplements. These companies get away with murder because they don't promise to help with disease, and aren't considered a "drug." However, they do promise all sorts of other outrageous claims, but there's no regulation because they aren't a drug.

I agree. So many of the weight loss supplements out there scare the crap out of me!

[tem_sat]

Originally Posted by Ellie May

I'd like to know how all the holistic supplement companies get away with what they do though if Hill's can't word things this way. I guess only because this is food and they don't do supplements at all.

I have not read all of this, but the answer to your question is probably here: Claims That Can Be Made for Conventional Foods and Dietary Supplements

There have, of course, been numerous successful lawsuits filed as well.